Deep vs Moderate Block: Impact on Operating Conditions & Patient Satisfaction

Study Overview
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Brief Summary
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This study compares surgeon's satisfaction of operating conditions and patient's satisfaction following laparoscopic gynecological surgeries in two groups of patients, half of whom will receive deep neuromuscular blockade and the other half, moderate neuromuscular blockade.

Detailed Description
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Deep neuromuscular blockade in anesthesia has been shown to improve operating conditions in retroperitoneal surgeries, while there is minimal evidence regarding this method in laparoscopic gynecological procedures.The advantage of improving surgical conditions with a deep neuromuscular blockade in laparoscopic surgery may however lead to a delayed neuromuscular recovery and hence a delay in turnover of patients. Rocuronium will be used for muscle relaxation in order to achieve the necessary depth of neuromuscular blockade. Sugammadex is a modified cyclodextrin that forms complexes with rocuronium, reducing free plasma concentrations of rocuronium and reversing its neuromuscular blocking action from any depth. The use of rocuronium will therefore aid in achieving a deep neuromuscular blockade which the investigators postulate will improve surgical conditions and the reversal with sugammadex will ensure a rapid recovery thereafter.

Official Title
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Comparing Deep Neuromuscular Block and Moderate Neuromuscular Block in Patients Undergoing Laparoscopic Gynaecological Surgeries: Impact on Surgical Satisfaction of Operating Conditions and Patient Satisfaction

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: Deep neuromuscular blockade
* Drug: Moderate neuromuscular blockade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients identified from the anaesthetic clinic scheduled to undergo a laparoscopic gynaecological procedure under general anaesthesia requiring tracheal intubation elective surgeries (eg. laparoscopy & dye insufflation, bilateral tubal ligation, cystectomy, myomectomy, hysterectomy, salpingo-oophorectomy) American Society of Anaesthesiology (ASA) I-II Exclusion Criteria: Anticipated difficult airway Patients requiring rapid sequence induction Patient anticipated to require admission to the intensive care unit (ICU) or not planned for extubation Patient with liver or renal failure (creatinine clearance <50mls/min) Patients with a baseline heart rate <50/min Patients with documented or suspected neuromuscular disorder Guillain - Barre syndrome Cerebrovascular accidents with residual neurology Parkinson's Disease Myasthenia Gravis Any condition making the administration of patient satisfaction questionnaire difficult/impossible • speech or hearing impairment and language barriers Patients on fusidic acid or toremifene 24 hours before surgery Patients on hormonal contraceptives; oral or otherwise Patients on drugs, medical problems that may prolong or shorten the duration of rocuronium- (eg.. aminoglycosides, magnesium) Patients with a history of allergy to rocuronium or sugammadex

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deep neuromuscular blockade<br>Rocuronium will be administered to achieve PTC 1-2 throughout surgery. | Drug: Moderate neuromuscular blockade<br>* Moderate neuromuscular blockade attained during surgery using Rocuronium 0.6mg/kg at induction with intermittent boluses of 0.15 - 0.2 mg/kg to maintain Train of Four Count (TOFC) of 2 throughout surgery. Neuromuscular blockade reversed at the end of surgery with Sugammadex 2mg/kg.<br>* Other names: Rocuronium, Esmeron;|
| Active Comparator: moderate neuromuscular blockade<br>Rocuronium will be administered to achieve TOFC 2 throughout surgery | Drug: Deep neuromuscular blockade<br>* Deep neuromuscular blockade attained during surgery using Rocuronium 0.6mg/kg at induction of anesthesia with intermittent boluses of 0.15 - 0.2 mg/kg to maintain a Post Tetanic Count (PTC) of 1-2 throughout surgery. Neuromuscular blockade reversed at the end of surgery with Sugammadex 4mg/kg.<br>* Other names: Rocuronium, Esmeron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep block versus Moderate block: Impact on surgical satisfaction | The surgeon will be required to score the quality of operating conditions every 15 minutes from 1st visualisation of peritoneal cavity until the removal of laparoscopes at the end of surgery. | Every 15 minutes from first laparoscopic view till the removal of laparoscopes at the end of surgery or up to 8 hours from 1st score. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep block versus Moderate block: Patient satisfaction score | A blinded recovery nurse will administer Patient Satisfaction Questionaire | Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU | 
| Deep block versus Moderate block: Pain score | A blinded recovery nurse will obtain the Pain Score using Visual Analogue Scale | Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU | 
| Deep block versus Moderate block: PONV Score | A blinded recovery nurse will obtain the PONV Score using 4 point PONV scoring | Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Gynecologic Surgeries