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

October 2, 2018 updated by: Loo Su Yin, Kuala Lumpur General Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: deep neuromuscular blockade
Rocuronium will be administered to achieve PTC 1-2 throughout surgery.
Drug: Moderate neuromuscular blockade
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.
Other Names:
  • Rocuronium, Esmeron
Active Comparator: moderate neuromuscular blockade
Rocuronium will be administered to achieve TOFC 2 throughout surgery
Drug: Deep neuromuscular blockade
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.
Other Names:
  • Rocuronium, Esmeron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep block versus Moderate block: Impact on surgical satisfaction
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.
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuala Lumpur General Hospital

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Vanitha Sivanaser, M.Med Anaes (UM), Kuala Lumpur General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 9, 2016

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVL#123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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