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

Phase 4

Withdrawn

• Conditions: Neuromuscular Blockade
• Interventions: Drug: Moderate neuromuscular blockade; Drug: Deep neuromuscular blockade

• Registration Number: NCT02794714
• Lead Sponsor: Kuala Lumpur General Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-05-19
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-09
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deep neuromuscular blockade	Moderate neuromuscular blockade	Rocuronium will be administered to achieve PTC 1-2 throughout surgery.
moderate neuromuscular blockade	Deep neuromuscular blockade	Rocuronium will be administered to achieve TOFC 2 throughout surgery

Primary Outcome Measures

Name	Time	Method
Deep block versus Moderate block: Impact on surgical satisfaction	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.	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.

Secondary Outcome Measures

Name	Time	Method
Deep block versus Moderate block: Patient satisfaction score	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	A blinded recovery nurse will administer Patient Satisfaction Questionaire
Deep block versus Moderate block: Pain score	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	A blinded recovery nurse will obtain the Pain Score using Visual Analogue Scale
Deep block versus Moderate block: PONV Score	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	A blinded recovery nurse will obtain the PONV Score using 4 point PONV scoring