Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794714
Recruitment Status : Withdrawn (unresolved budget issues)
First Posted : June 9, 2016
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Loo Su Yin, 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.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Deep neuromuscular blockade Drug: Moderate neuromuscular blockade Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Deep Neuromuscular Block and Moderate Neuromuscular Block in Patients Undergoing Laparoscopic Gynaecological Surgeries: Impact on Surgical Satisfaction of Operating Conditions and Patient Satisfaction
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Rocuronium, Esmeron




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794714


Sponsors and Collaborators
Kuala Lumpur General Hospital
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Vanitha Sivanaser, M.Med Anaes (UM) Kuala Lumpur General Hospital
Publications:

Layout table for additonal information
Responsible Party: Loo Su Yin, Dr, Kuala Lumpur General Hospital
ClinicalTrials.gov Identifier: NCT02794714    
Other Study ID Numbers: CVL#123
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Loo Su Yin, Kuala Lumpur General Hospital:
Laparoscopic Gynecologic Surgeries
Additional relevant MeSH terms:
Layout table for MeSH terms
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs