Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Dexmedetomidine

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Patients were assigned to receive 0.9% saline intranasally 45 min before surgery using a computer-generated random number table.

Patients were assigned to receive 1µg.kg-1dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

Patients were assigned to receive 1.5µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

Patients were assigned to receive 2µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

0.9% saline intranasally 45 min before surgery using a computer-generated random number table.

0.9% saline

dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

dexmedetomidine 1µg.kg-1

Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

dexmedetomidine 1.5µg.kg-1

dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

Dexmedetomidine 2µg.kg-1

This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the optimal dose of intranasal DEX in breast lumpectomy.

Breast lumpectomy associated with a high level of anxiety, fear and pain requires fast and effective anaesthesia techniques. Presently, this procedure is usually performed under general or local anaesthesia. General anaesthesia provides an effective sedation; however, for minor procedures, general anaesthesia is resource-intensive and postoperative complications, such as nausea, vomiting or extended time to ambulation, are more likely. Local anaesthesia alone may be uncomfortable or uncooperative for patients. Therefore, an efficient drug regimen is required that reduces analgesic consumption, minimises opioid-related side effects and shortens post-anaesthesia care unit (PACU) stay following surgery.

Dexmedetomidine (DEX) is a highly selective α2 adrenoreceptor agonist that provides sedation without respiratory depression. Its sedative, anxiolytic, analgesic and haemodynamic effects have made it a useful adjunct to anaesthesia and sedation. DEX may provide a conscious sedation under monitored anaesthesia care (MAC) that is a logical middle ground between general anaesthesia and local anaesthesia. Intranasal DEX was recently shown to provide satisfactory anaesthesia and premedication sedation in healthy volunteers and paediatric patients. The intranasal route is not only effective, but also well-tolerated and convenient This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia, and to investigate the optimal dose of intranasal DEX in breast lumpectomy.

Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia

Tianjin Medical University Cancer Institute and Hospital

intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

placebo

Xiangcai Ruan, MD, PHD

Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. However, phenobarbital, as the traditional premedication, has less sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative, anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore, dexmedetomidine as premedication has certain advantages. The purpose of this research is to study sedative effect, safety and the impact of anesthesia recovery period of intranasal dexmedetomidine premedication for suspension laryngoscopy.

All patients received intranasal dexmedetomidine (1μg.kg-1) or placebo at approximately 45 min before induction of anesthesia.The study drug was prepared in a 1-ml syringe.An equal volume of dexmedetomidine or placebo was dropped into each nostril by a blinded research assistant in the supine position.Automatic sphygmomanometer measure blood pressure.Oxygen saturation and heart rate were measured by a pulse oximeter. Respiratory rate, sedation score and anxiety levels regularly assessed. Patients with general anesthesia, suspension laryngoscopy surgery and postoperative care, standard monitoring are unified.

Intranasal Dexmedetomidine Premedication

A Randomised Controlled Trial of Intranasal Dexmedetomidine as Premedication for Suspension Laryngoscopy

Baseline characteristic data of patients receiving intranasal placebo The weights of 41 adult patients receiving intranasal placebo

Baseline characteristic data of patients receiving intranasal dexmedetomidine The weights of 40 adult patients receiving intranasal dexmedetomidine

Baseline characteristic data of patients receiving intranasal placebo The heights of 41 adult patients receiving intranasal placebo

Baseline characteristic data of patients receiving intranasal dexmedetomidine The heights of 40 adult patients receiving intranasal placebo

Baseline characteristics (sex)of patients receiving intranasal placebo or dexmedetomidine The sex of 81 adult patients receiving intranasal placebo or dexmedetomidine

American Society of Anesthesiologists (ASA) status of patients receiving intranasal placebo or dexmedetomidine.

ASA I: No organic, physiologic, biochemical or psychiatric disturbance ASA II: A patient with mild systemic disease that results in no functional limitation.

ASA III: A patient with severe systemic disease that results in functional impairment.

ASA IV: Severe systemic disease that is a constant threat to life. ASA V: Moribund condition in a patient who is not expected to survive with or without the operation.

ASA VI: Declared brain death patient whose organs are being harvested for transplantation.

Duration from intranasal drug administration to arrival at operating room of patients receiving intranasal placebo surgical data of patients receiving intranasal placebo

Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal dexmedetomidine surgical data of patients receiving intranasal dexmedetomidine

Duration from intranasal drug administration to anesthesia intubation of Patients Receiving Intranasal Placebo surgical data of patients receiving intranasal placebo

Duration of minutes From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal dexmedetomidine surgical data of Patients Receiving Intranasal dexmedetomidine.

Duration of anesthesia of patients receiving intranasal placebo Duration from anesthesia intubation to anesthesia ending

Duration of anesthesia of patients receiving intranasal dexmedetomidine Duration from anesthesia intubation to anesthesia ending

Duration of surgery of patients receiving intranasal placebo Duration from surgery beginning to anesthesia ending

Duration of surgery of patients receiving intranasal dexmedetomidine. Duration from surgery beginning to anesthesia ending

Modified OAA/S score of patients receiving intranasal placebo Before intranasal drugs Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

Modified OAA/S score of patients receiving intranasal dexmedetomidine Before intranasal drugs Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

Modified OAA/S score of patients receiving intranasal placebo at Pre-induction.

Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):

6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

Modified OAA/S score of patients receiving intranasal dexmedetomidine at Pre-induction.

Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):

6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

Modified OAA/S score of patients receiving intranasal placebo After extubation. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

Modified OAA/S score of patients receiving intranasal dexmedetomidine after extubation.

Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):

6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

Anxiety score of Patients Receiving Intranasal Placebo Before Intranasal Drugs. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)

Anxiety score of Patients Receiving Intranasal dexmedetomidine Before Intranasal Drugs.

The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)

Anxiety score of Patients Receiving Intranasal Placebo at Pre-induction. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)

Anxiety score of Patients Receiving Intranasal dexmedetomidine at Pre-induction.

The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)

Satisfaction scores of patients receiving intranasal placebo. satisfaction was assessed using a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).

Satisfaction scores of patients receiving intranasal dexmedetomidine. Satisfaction used a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).

Time to spontaneous breathing of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and adequate ventilation

Time to spontaneous breathing of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and adequate ventilation

Time to consciousness of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and consciousness.

Time to consciousness of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and consciousness.

Time to extubation of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and extubation

Time to extubation of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and extubation

Predicted effect-site concentrations of propofol after intranasal placebo at tracheal intubation.

Propofol was infused intraoperatively to a target-controlled infusion (TCI) plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at tracheal intubation.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal placebo before inserting operative laryngoscope.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal dexmedetomidine before inserting operative laryngoscope.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal placebo on removal of operative laryngoscope.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal dexmedetomidine on removal of operative laryngoscope.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal placebo at return of spontaneous breathing.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at return of spontaneous breathing.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal placebo at emergence.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at emergence.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal placebo at extubation.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at extubation.

Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

Predicted effect-site concentrations of remifentanil after intranasal placebo at tracheal intubation.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at tracheal intubation.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal placebo before inserting operative laryngoscope.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine before inserting operative laryngoscope.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal placebo on removal of operative laryngoscope.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine on removal of operative laryngoscope.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal placebo at return of spontaneous breathing.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at return of spontaneous breathing.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal placebo at emergence.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at emergence.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal placebo at extubation.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at extubation.

Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

HR in the placebo group Before Intranasal Drugs HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room

HR in the dexmedetomidine group Before Intranasal Drugs . HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room

HR in the placebo group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room

HR in the dexmedetomidine group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room

Patients with postoperative analgesia in two groups. analgesic requests within 2 h after extubation were recorded. An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.

Patients With postoperative nausea in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.

Patients With postoperative vomiting in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.

Patients With postoperative shivering in Two Groups. the occurrence of postoperative shivering

Patients With intra-operative awareness in Two Groups. patients receiving intranasal placebo or dexmedetomidine

An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.

The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration

Modified Observer's Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine.

Modified Observer's Assessment of Alertness/Sedation Scale:

6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus.

Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study.

satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction.

Anxiety score \>2 was considered to be better for the patient.

4-point anxiety score:

1. = combative
2. = anxious
3. = calm
4. = amiable. Anxiety score \>2 was considered to be better for the preoperative patients.

Systolic blood pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine.

Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU).

Satisfaction score \<2 was considered to be better for the patient

Bradycardia was defined as heart rate (HR) \<45 bpm for more than 10 s.

Tachycardia was defined as heart rate (HR) \>100 bpm for more than 10 s.

Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min.

Hypertension was defined as systolic blood pressure (SBP) increased 130% of the pre-operative value for more than 1 min.

Guangzhou First People's Hospital

Vice Chair

intranasal dexmedetomidine

Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

intranasal saline

placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia	NCT02675049	Intranasal Dexm...	0.9% saline dexmedetomidine... dexmedetomidine... Dexmedetomidine...	20 Years - 60 Years	Tianjin Medical University Cancer Institute and Hospital
Intranasal Dexmedetomidine Premedication	NCT02108171	Benign Neoplasm...	Dexmedetomidine placebo	18 Years - 60 Years	Guangzhou First People's Hospital
Intranasal Dexmedetomidine Premedication	NCT02108171	Benign Neoplasm...	Dexmedetomidine placebo	18 Years - 60 Years	Guangzhou First People's Hospital
Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia	NCT02675049	Intranasal Dexm...	0.9% saline dexmedetomidine... dexmedetomidine... Dexmedetomidine...	20 Years - 60 Years	Tianjin Medical University Cancer Institute and Hospital
Patient Satisfaction and Quality of Life Impact - PecFent®	NCT01698645	Breakthrough Ca...	PecFent® (fenta...	18 Years -	Archimedes Development Ltd
Patient Satisfaction and Quality of Life Impact - PecFent®	NCT01693328	Breakthrough Ca...	PecFent® (fenta...	18 Years -	Archimedes Development Ltd

Spots Global Cancer Trial Database for intranasal

Every month we try and update this database with for intranasal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for intranasal

Every month we try and update this database with for intranasal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for intranasal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.