Neoplasms

Digestive System Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Obesity

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

All Drugs and Chemicals

Pharmaceutical Solutions

Anticonvulsants

Rocuronium

Bromides

Neuromuscular Blocking Agents

Vecuronium Bromide

Sugammadex sodium 4mg/kg/IV after operation

Sugammadex sodium 2mg/kg/IV after operation

1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.
2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.

Sugammadex Sodium

Sung soo Park, MD,PhD

This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction.

The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons

* Deep neuromuscular block group (98persons)
* Moderate neuromuscular group (98persons)

This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. This is a randomized controlled trial comparing deep NMB with moderate NMB in laparoscopic subtotal gastrectomy in obese patients with gastric cancer. The design of the study is blinded (the surgical team and the research team are all blinded to the treatment); the attending anesthesiologist is not blinded. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction.

The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons

* Deep neuromuscular block group (98persons)
* Moderate neuromuscular group (98persons) The patients are assigned to the deep NMB group or the moderate NMB group. The clinical research coordinator (CRC) uses a computer randomization program to determine the degree of muscle relaxation of each patient. Stratified block randomization is used to guarantee even distribution, which means that all participating hospitals are assigned moderate or deep NMB randomly in a 1:1 ratio. The CRC notifies the anesthesiologist of the degree of muscle relaxation just before the operation. Surgeons are blinded to the degree of muscle relaxation: They can enter the operating room after the muscle relaxation has been performed. A train-of-four (TOF) monitor is placed out of the surgeon's visual field. The anesthesiologist injects sugammadex after confirming the absence of the surgeon. The ward staff members who evaluate patient outcomes are blinded to the degree of muscle relaxation.

Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient

A Double-blind, Randomized and Controlled Multicenter Prospective Trial to Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient

Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery

Surgical rating score (SRS) at Four anatomical area during LN dissection

During surgery, the surgeon reported the SRS based on the Leiden surgical rating scale (1=extremely poor, 2=poor, 3=acceptable, 4=good, 5=optimal) for each anatomical landmark (LN stations 4sb, 6, and 5 and the suprapancreatic area).

Interrupted event by patient movement, coughing, muscle spasm during operation

Korea University Anam Hospital

Professor

Sugammadex sodium 4mg/kg/IV after operation

Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.

2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.

Deep Neuromuscular Block Group

Sugammadex sodium 2mg/kg/IV after operation

Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.

2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.

Moderate Neuromuscular Group

Total

The effect of "Age" on oncological quality should be also considered. So, we categorize the patient according to "Age". Age is an important factor when considering phenotypic changes in health and disease. Age-related physiological changes can affect pharmacokinetics and pharmacodynamics of the drug. Typically, clinical trials categorize patients according to the age of 18 and 65 years.

Age, Categorical

Age, Continuous

We tried to evaluate the impact of depth of neuromuscular block on oncological quality of laparoscopic surgery. In this circumstances, the effect of gender on oncological quality should be also evaluated. So, we categorize the patient according to "Sex".

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

South Korea

Region of Enrollment

Obesity hinders laparoscopic procedures and impedes oncological safety during laparoscopic cancer surgery. We aimed to evaluate whether deep neuromuscular block improves oncologic quality of laparoscopic cancer surgery in obese patients. So, we checekd wheter there is any difference in BMI between two groups.

Body mass index (kg/m^2)

The American Society of Anesthesiologists (ASA) physical status classification offers clinicians a simple categorization of a patient's physiological status that can be helpful in predicting operative risk

1. ASA I : No organic pathology or patients in whom the pathological process does not cause any systemic disturbance or abnormality.
2. ASA II: moderate but definite systemic disturbance, caused by the condition that is to be treated or surgical intervention. (Mild diabetes, Anemia)
3. ASA III: Severe systemic disturbance (Combinations of heart disease and respiratory disease)

ASA classification

Ten patients were excluded from the deep neuromuscular block group (7: protocol violation, 3: withdrew consent) and 5 patients were excluded from the moderate neuromuscular block group (3: protocol violation, 2: withdrew consent).

Dr. Shin Hoo Park

Total number of patients

The patients with BMI ≥28kg/m^2

This study originally intended to analyze whether a deeper depth of NMB can increase the number of retried LNs in obese gastric cancer patients. We tried to find a certain BMI point where the mean number of LNs showed a significant difference depending on the depth of NMB. BMI 28 was the starting point for the difference in the mean number of retrieved LNs.

Number of Retrieved Lymph Nodes Per Participant

SRS in LN #4sb

SRS in LN #5

SRS in LN #6

SRS in supra-pancreatic area

Average SRS from 4 area

Surgical Rating Score (SRS)

Number of Participants With at Least One Interruption Event

Intraoperative Blood Loss Amount

Overall Study

Substance Related Disorders

Neoplasm Metastasis

Fistula

Drug-Related Side Effects and Adverse Reactions

Pathological Conditions, Anatomical

Chemically-Induced Disorders

Central Nervous System Depressants

Analgesics

Adjuvants, Anesthesia

Psychotropic Drugs

Anesthetics

Oxycodone

Midazolam

Propofol

Analgesics, Opioid

Remifentanil

Flumazenil

Opiate Alkaloids

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Narcotics

Neuromuscular Nondepolarizing Agents

Antidotes

Protective Agents

GABA Modulators

Neurotransmitter Agents

Remazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction.Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance.

Propofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia.Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance.

Remimazolam is a new drug innovation in anesthesia. It combines the properties of two unique drugs already established in anesthesia - Midazolam and remifentanil. It acts on GABA receptors like midazolam and has organ-independent metabolism like remifentanil.

Remimazolam

Propofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures.

Rocuronium is a non-depolarizing neuromuscular blocker

Remifentanil is an esterase-metabolized opioid

oxycodone

Sugammadex sodium is an organic sodium salt that is the octasodium salt of sugammadex. Used for reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery

Flumazenil is used to reverse the effects of a benzodiazepine

This study is a prospective, randomized, controlled trial. In this study, 30 patients who underwent endotracheal tumor resection under rigid bronchoscope or stent placement for acquired tracheoesophageal fistula were selected as the subjects. The patients were randomly divided into remazolam general anesthesia group (R group) and propofol general anesthesia control group (P group). Remazolam general anesthesia group (R group): Remazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction. Propofol general anesthesia control group (P group): Propofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia. After induction, high-frequency jet ventilation was used in both groups, the respiratory rate was 30-60 times/min, the inspiratory-to-breath ratio was 1:2, and the driving pressure was 0.8-1.0 KPa. Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance. Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance. The dosage of propofol or remazolam was adjusted according to BIS and intraoperative hemodynamic changes. Rocuronium bromide 10 mg was added every half hour. Intraoperative application of vasoactive drugs to maintain mean arterial pressure above 60mmHg to avoid perioperative hypotension. Blood oxygen saturation and end-tidal carbon dioxide were monitored to avoid perioperative hypoxemia and hypercapnia, and warm measures were used to maintain the patient's intraoperative body temperature above 36.0°C. After surgery, group R was treated with sugammadex sodium 2-4 mg/kg to antagonize rocuronium bromide, and 0.5 mg of flumazenil was used to antagonize remazolam by intravenous injection; group P was treated with sugammadex 2-4 mg/kg to antagonize rocuronium.

Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy

Department of Anesthesiology, Cancer Hospital of the University of Chinese Academy of Sciences（Zhejiang Cancer Hospital), Research Center for Neuro-Oncology Interaction , Institute of Basic Medicine and Cancer, Chinese Academy of Sciences

Taking the stop of general anesthesia as the starting point for timing, the time for the patient to correctly complete the three commands of nodding, mouth opening and tongue extension is recorded, with seconds as the timing unit

Modified Brice interview over quality assurance techniques in detecting intraoperative awareness.

Fluctuations in intraoperative systolic, diastolic pressures and mean arterial pressure will be recorded

PONS is a modified version of the malnutrition universal screening tool and determines the presence of nutrition risk based on BMI, recent body weight loss, decrement of dietary intake, and preoperative albumin concentration.

The time from the start of peripheral intravenous injection of general anesthetic to the patient's loss of consciousness. Time is measured in seconds.

The proportion of cases of postoperative delirium in the enrolled patients

Fluctuations in intraoperative heart rate will be recorded

The proportion of cases of postoperative vomiting in the enrolled patients

Zhejiang Cancer Hospital

Clinical Professor

Gland and Hormone Related Diseases

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Recurrence

Thyroid Neoplasms

Thyroid Diseases

Paralysis

Vocal Cord Paralysis

Goiter

Neurologic Manifestations

Laryngeal Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Vagus Nerve Diseases

Cranial Nerve Diseases

Group I.IONM in thyroid surgery.Once the vagus has been detected,nerve conduction data will be detected with IONM. If the muscle relaxant effect is not detected, it will be detected with TOF device.

Group B.the vagal nerve is detected and then 2 mg / kg of sugammadex sodium is administered to remove the muscle relaxant effect

Group B. Sugammadex sodium-IONM

Turgut Donmez, surgeon

Mehmet Emin Gunes, surgeon

Turgut Donmez, MD

Thyroidectomy is a frequently performed surgeon by the head and neck and endocrine surgeons. In recent years, surgical techniques and technological developments have resulted in a significant reduction in complication rates. Despite these advances, there is still a great deal of anxiety about the sound problems that can be experienced in patients after surgery. In the past years,the investigators have tried to prevent recurrent nerve paralysis by using intraoperative nerve monitoring (IONM). The use of IONM has begun to be preferred by many surgeons in the investigator's country. However, the use of IONM decreases the number of recurrent nerve paralysis are still being discussed and many studies have been done. In this study, it is aimed to prevent the formation of recurrent nerve paralysis in order to safely carry out the IONM by removing the effects of neuromuscular blockade drugs using sugammadex sodium medicine in the thyroidectomy operations.

Patients who will undergo thyroidectomy using the IONM in the General Surgery Clinic of Istanbul, Bakırköy Dr.Sadi Konuk Training and Research Hospital. In this prospective observational clinical trial, the patients will be divided into two groups and the study will be performed as randomize. Randomization Patients who arrive consecutively, will be included in the study group (Group I IONM, group B IONM-sugammadex sodium). In both groups, anesthesia induction should be done with 3 mg / kg propofol, 2 ugr / kg fentanyl, 0.6 mg / kg rocuronium bromide, as the intubation tube, the number appropriate for the patient, After reaching the throat loom, the patient is entrapped and then the operation is started. After reaching the thyroid loin and hanging the throid with the swab sutures, the lobe is taken out with the finger maneuver and then the vascular nerve packet is dissected and the vagal nerve is exposed. IONM(Medtronic-NIM) were detected in the recurrent nerve thyroglossal groove and 100 microvolts or more were measured with nerve monitoring. + Acceptance of resection was started and IONM After the intubation of the group B-sugammadex sodium was started, the left hand ulnar sinus TOF-Guard device was placed and operation started. After reaching the thyroid loops and hanging the throids with hanging sutures and removing the lobe with finger maneuver, the vascular nerve was disassembled and the vagal nerve was dislocated. Then the electrical value was recorded with IONM and sugammadex sodium 2 mg / kg was made. and the TOF response at 4th minute is over 90% of the value to be measured and if the IONM is 100 microvolts higher, the recurrent nerve is found in the troglossal groove and the nerve is followed with the IONM and the resection procedure is started and the tirodidectomy will be performed. V0: vagal nerve initial value; V1: value before troid resection; V2: value after troid resection; R1: value after troid resection, R2: value after troid resection. Preoperative and postoperative vocal cord examination will be examined by otolaryngologist. Size, weight, sex, ASA scores, operation times, complications will be recorded. If there is no signal in RLN with intraoperative IONM and RLN paralysis will be accepted if there is inactivity in the vocal cord at the 1st postoperative ENT specialist vocal cord examinations. RLN paralysis will be accepted if there is inactivity in the cord at the vocal cord examination of the postoperative specialist ENT specialist. The ENT specialist and general surgeon will follow up and if the vocal cord is still in motion, the permanent RLN will be considered a paralysis.

Group A. Sugammadex sodium-IONM in thyroid surgery Group B.Standart technique-IONM in thyroid surgery

Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery

Reversal of Rocuronium-Induced Neuromuscular Blockade by Sugammadex Increase for Efficiency of Intraoperative Neural Monitoring in the Thyroid Surgery

Patients who are accepted to participate in the study will be gathered in the pool. The patients' data will be entered on the computer. The computer and patients will be randomized and set up on the day of surgery. The preop, perop and postop data of the patients will be recorded on the computer.

postoperative vocal cord examination will be performed and the recurrent laryngeal nerve will be examined.

V1: value to receive enough nerve conduction for IONM use from the vagus nerve

V2:Vagus value after resection of thyroid lobe

initial value after vagus sinus is detected

the time that the muscle relaxant is shown by the peripheral nerve stimulator whose effect has disappeared.TOF\>0.9

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient	NCT03196791	Gastric Cancer Obesity	Sugammadex Sodi...	19 Years - 75 Years	Korea University Anam Hospital
Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy	NCT05468671	Endobronchial M... Bronchoesophage... General Anesthe...	Remimazolam Propofol Rocuronium Remifentanil oxycodone Sugammadex Sodi... Flumazenil	18 Years -	Zhejiang Cancer Hospital
Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery	NCT03634956	Vocal Cord Para... Recurrent Laryn...	Group B. Sugamm...	18 Years - 75 Years	Lütfiye Nuri Burat Government Hospital

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