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

Kuala Lumpur General Hospital

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Neuromuscular Blockade

Interventions

Deep neuromuscular blockadeDRUG

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.

Moderate neuromuscular blockadeDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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) 2. American Society of Anaesthesiology (ASA) I-II Exclusion Criteria: 1. Anticipated difficult airway 2. Patients requiring rapid sequence induction 3. Patient anticipated to require admission to the intensive care unit (ICU) or not planned for extubation 4. Patient with liver or renal failure (creatinine clearance \<50mls/min) 5. Patients with a baseline heart rate \<50/min 6. Patients with documented or suspected neuromuscular disorder * Guillain - Barre syndrome * Cerebrovascular accidents with residual neurology * Parkinson's Disease * Myasthenia Gravis 7. Any condition making the administration of patient satisfaction questionnaire difficult/impossible • speech or hearing impairment and language barriers 8. Patients on fusidic acid or toremifene 24 hours before surgery 9. Patients on hormonal contraceptives; oral or otherwise 10. Patients on drugs, medical problems that may prolong or shorten the duration of rocuronium- (eg.. aminoglycosides, magnesium) 11. Patients with a history of allergy to rocuronium or sugammadex

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

Deep block versus Moderate block: Patient satisfaction score

A blinded recovery nurse will administer Patient Satisfaction Questionaire

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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