Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Rare Diseases

Pleural Effusion

Pleural Effusion, Malignant

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Chronic Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Psychotropic Drugs

Anesthetics

Fentanyl

Dexmedetomidine

Midazolam

Dexmedetomidine infusion for pleuroscopy sedation. Rescue drugs will be midazolam for inadequate sedation and fentanyl for pain control

Midazolam for sedation and fentanyl for pain will be used for pleuroscopy monitored anesthesia care

The primary objective of this prospective trial will be to assess the effects of dexmedetomidine administration on oxygenation and respiratory function in patients undergoing diagnostic or therapeutic medical thoracoscopy/pleuroscopy for a pleural effusion compared to conventional conscious sedation/monitored anesthesia care (MAC) with midazolam. The secondary endpoint of the study will be to also assess the effects of dexmedetomidine administration on respiratory mechanics and postprocedural complications

The study will be conducted at the Department of Anesthesiology and Pain Management in collaboration with the Department of Thoracic Surgery at the Attikon University Hospital, Athens.

The trial has received approval by the Attikon University Hospital's Scientific \& Bioethics Committee and written informed consent will be obtained from all patients enrolled in the study.

Sample Size Calculation: A total of 60 patients will be assigned on a 1 to 1 basis to avoid bias to either a "DEX = dexmedetomidine" (n=30) or a "MIDAZOLAM/FENTANYL" group (n=30). To determine the required sample sizes quoted above, the statistical G-power calculator developed by Faul, Erdfelder, Lang, and Buchner was used. Values used to calculate the effect size (e=0.9326031) are based on results previously reported in the literature. For a study power of 90% with an alpha value of 0.05, a total of 26 patients in each group will need to be enrolled. Factoring in possible losses this number was rounded up to 30 patients per group.

Main Measurements Performance \& Methods: Patients will initially be assessed with spirometry and arterial blood gas (ABG) analysis prior to the medical thoracoscopy/pleuroscopy to determine their baseline values of Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and Partial arterial Pressure of Oxygen/ Fraction of Inspiratory Oxygen (PaO2/FiO2) ratio respectively. Intra-operatively repeat ABG analysis will be performed at 30 minutes following the start of administration of the study drug. Subsequent to their medical thoracoscopy/pleuroscopy procedure study subjects will remain in the Post Anesthesia Care Unit (PACU) for a minimum of 1 hour following the discontinuation of the study drug. Repeated ABG analysis and spirometry will be carried out at that 1 hour to assess improvement over the pre-operative values. The administration of the spirometry exam will be by the same pulmonologist using the same spirometer device so as to minimize inter-observer variability. Arterial blood gas measurements will also be performed in the same analysis device.

Protocol for Sedation \& Analgesia: Dexmedetomidine (DEX) group: Initial loading dose of dexmedetomidine will be 1.0 μg/kg of dexmedetomidine administered over 10 minutes. Fifteen minutes after starting the study drug administration, patients will be assessed for their level of sedation using the Observer's Assessment of Alertness/Sedation Scale (OAA/S), and any patient having a score ≥3 will receive intravenous (IV) midazolam in 0.5 mg doses, which will be repeated until the OAA/S is ≤2. MIDAZOLAM/FENTANYL group: Patients will be assessed for their level of sedation using the Observer's Assessment of Alertness/Sedation Scale (OAA/S), and any patient having a score ≥3 will receive intravenous (IV) midazolam in 0.5 mg doses, which will be repeated until the OAA/S is ≤2 All subjects will receive local anesthesia prior to the commencement of the "open" trocar insertion technique performed by the thoracic surgeon at the point of introduction of the rigid trocar in the pleural cavity with a combination of lidocaine 1.5% and ropivacaine 0.75%. If a patient is not adequately sedated, rescue midazolam will be administered as single IV boluses of 0.5 mg, which will be repeated as needed to achieve an OAA/S score of ≤3. Intravenous fentanyl, 25 μg boluses which can be repeated as necessary, will be given if a patient expresses a pain score of ≥3 during the study drugs infusion and ≥4 in the PACU on a Verbal scale of 0-10 (0 = no pain, 10 = worst pain), or if the anesthetist determines the presence of pain when verbal communication is not possible. Blood gas analysis will be obtained at 30' and 60' minutes intraoperatively. The dexmedetomidine infusion will be discontinued after wound closure.

At any time, if clinically indicated, the patient will be converted to an alternative sedative or anesthetic therapy and the study will be discontinued. OAA/S scores and all standard vital signs will be obtained every 5 min throughout the study drug infusion and before the administration of any rescue midazolam.

The time to reach OAA/S =5 from the end of infusion will be recorded. Other data recorded at the end of surgery will include total fentanyl and midazolam used intraoperatively, crystalloid infusion in litres, total mcg of the study drug (provided a \[dex\] = 4 mcg/ml) and postoperative Visual Analogue Scale (VAS) pain score. If VAS\>3 acetaminophen 1 g will be administered. The patient's monitoring will be continued in the post-anesthesia care unit (PACU) with vital signs been recorded every 5 minutes for the first 15 minutes, then every 15 minutes for the next 45 minutes. Blood gas analysis will be obtained every 30' until discharge from the PACU. At 24 hours from the end of surgery, a spirometry will be performed. Patient satisfaction and surgeon satisfaction score will also be registered (4-point scale - 0 min to 3 max). Patients will be discharged from the PACU when their OAA/S score =5.

Respiratory Function of Dexmedetomidine in Patients Undergoing Pleuroscopy

The Effect on Respiratory Function of Monitored Anesthesia Care With Dexmedetomidine in Patients Undergoing Diagnostic or Therapeutic Pleuroscopy

This 5 point Scale is used to assess level of sedation during the procedure (5- 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 and/or repeatedly, 2-Responds only after mild prodding or shaking, 1-Does not respond to mild prodding or shaking)

incidence of bradycardia (HR \<45 beats/ min) during procedure

incidence of hypotension (MAP\<65 mmHg) during procedure

incidence of hypoxemia (SaO2\< 92%) during procedure

Attikon Hospital

Assistant Professor of Anesthesiology

Lung Neoplasms

Lung Diseases

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Remifentanil

Racepinephrine

Epinephryl borate

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Analgesics, Opioid

Narcotics

Remifentanil IV bolus 0.5 mcg/kg bolus in 10 minutes. Initial bolus followed by infusion 0.05-0.25 mcg/kg/min for OAA/S 2-3. Remifentanil IV bolus 0.3 mcg/kg PRN for time-limited painful stimuli.

Dexmedetomidine 0.4 mcg/kg IV bolus in 10 minutes. Dexmedetomidine 0.5-1.0 mcgg/kg/h for OAA/S 2-3. Midazolam 0.015 mg/kg bolus IV PRN.

Olivier Verdonck, MD

Nadia Godin, RN

Lung cancer is the second most commonly diagnosed primary neoplasia in Canada accounting for 22 865 new cases in 2007. Recent randomized trials have shown a significantly better diagnostic yield and fewer unnecessary thoracotomies with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) when compared to conventional TBNA for various clinical conditions including peripheral pulmonary lesions and sarcoidosis. EBUS-TBNA are now routinely performed in our institution for staging of pulmonary and mediastinal cancer. EBUS-TBNA are performed under monitored anesthesia care (MAC) in the endoscopy suite at the Centre de soins ambulatoires of the Hôpital Maisonneuve-Rosemont.

Remifentanil, used in combined regime or as single agent proved to be effective and safe for MAC. Nonetheless, anesthesiologists are still confronted to the respiratory depression profile of remifentanil and other commonly used agents. An analysis of the ASA Closed Claims demonstrated that respiratory depression remains a significant drawback during MAC in remote locations. Furthermore, patients with coexisting pulmonary diseases scheduled for EBUS-TBNA are at increased risk of such complications.

The investigators hypothesize that compared to the use of remifentanil-based MAC protocol, the use of dexmedetomidine-based MAC protocol for EBUS-TBNA will result in a lower incidence of major respiratory and hemodynamic adverse events (bradypnea, apnea, oxygen desaturation, hypotension, hypertension, bradycardia and tachycardia) with equivalent overall procedure conditions.

Safety Evaluation of Dexmedetomidine for EBUS-TBNA

Safety Evaluation of Dexmedetomidine Monitored Anesthesia Care for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Bradypnea,apnea, oxygen desaturation, hypotension, hypertension, heart rate \<45 beats per minute, heart rate ≥120 beats per minute

Vocal cord movement before fiberscope passage

Observer's Assessment of Alertness/Sedation Scale (OAA/S) throughout the EBUS-TBNA procedure. Specific time points: before fiberscope nasal insertion, before vocal cord passage, after vocal cord passage and at the end of the procedure.

Aldrete score immediately after removal of fiberscope, time for Aldrete score equal or superior to 9 (assesed at 5 minute intervals).

Cumulative dose of lidocaine administered by the endoscopist

Cumulative dose of vasopressor administered

Coughing episodes throughout the EBUS-TBNA procedure

Endoscopist global satisfaction score based on a 4-point Likert scale

Recall evaluation once Aldrete score superior to 9 in post anesthesia care unit. Evaluation based on a 4-point Likert scale

Maximal pain evaluation based on a visual analog scale. Score measured once an Aldrete score superior to 9 in the post anesthesia care unit is achieved.

Global patient satisfaction associated with the procedure. Score based on a 5 point Likert scale. Measured before patient leaves the post anesthesia care unit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Respiratory Function of Dexmedetomidine in Patients Undergoing Pleuroscopy	NCT03597828	Pleural Effusio... Pleural Effusio... Pleural Disease...		18 Years - 100 Years	Attikon Hospital
Safety Evaluation of Dexmedetomidine for EBUS-TBNA	NCT01381627	Lung Cancer	Remifentanil Dexmedetomidine	18 Years - 75 Years	Maisonneuve-Rosemont Hospital

Spots Global Cancer Trial Database for monitored anesthesia care