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

NCT02794714 | Withdrawn Phase 4

• 1 other identifier: CVL#123
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuromuscular Blockade

Keywords

Laparoscopic Gynecologic Surgeries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

deep neuromuscular blockade

EXPERIMENTAL

Rocuronium will be administered to achieve PTC 1-2 throughout surgery.

Drug: Moderate neuromuscular blockade

moderate neuromuscular blockade

ACTIVE COMPARATOR

Rocuronium will be administered to achieve TOFC 2 throughout surgery

Drug: Deep neuromuscular blockade

Interventions

Deep neuromuscular blockade DRUG

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.

Also known as: Rocuronium, Esmeron

moderate neuromuscular blockade

Moderate neuromuscular blockade DRUG

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.

Also known as: Rocuronium, Esmeron

deep neuromuscular blockade

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kuala Lumpur General Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (15)

• Song D, Joshi GP, White PF. Fast-track eligibility after ambulatory anesthesia: a comparison of desflurane, sevoflurane, and propofol. Anesth Analg. 1998 Feb;86(2):267-73. doi: 10.1097/00000539-199802000-00009.

  PMID: 9459231 BACKGROUND

• Gupta A, Stierer T, Zuckerman R, Sakima N, Parker SD, Fleisher LA. Comparison of recovery profile after ambulatory anesthesia with propofol, isoflurane, sevoflurane and desflurane: a systematic review. Anesth Analg. 2004 Mar;98(3):632-41, table of contents. doi: 10.1213/01.ane.0000103187.70627.57.

  PMID: 14980911 BACKGROUND

• Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.

  PMID: 15896435 BACKGROUND

• Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

  PMID: 24240315 BACKGROUND

• Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.

  PMID: 24809482 BACKGROUND

• Geldner G, Niskanen M, Laurila P, Mizikov V, Hubler M, Beck G, Rietbergen H, Nicolayenko E. A randomised controlled trial comparing sugammadex and neostigmine at different depths of neuromuscular blockade in patients undergoing laparoscopic surgery. Anaesthesia. 2012 Sep;67(9):991-8. doi: 10.1111/j.1365-2044.2012.07197.x. Epub 2012 Jun 14.

  PMID: 22698066 BACKGROUND

• Woo T, Kim KS, Shim YH, Kim MK, Yoon SM, Lim YJ, Yang HS, Phiri P, Chon JY. Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in Korean patients. Korean J Anesthesiol. 2013 Dec;65(6):501-7. doi: 10.4097/kjae.2013.65.6.501. Epub 2013 Dec 26.

  PMID: 24427455 BACKGROUND

• Carron M, Veronese S, Foletto M, Ori C. Sugammadex allows fast-track bariatric surgery. Obes Surg. 2013 Oct;23(10):1558-63. doi: 10.1007/s11695-013-0926-y.

  PMID: 23519634 BACKGROUND

• Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.

  PMID: 18946293 BACKGROUND

• Della Rocca G, Pompei L, Pagan DE Paganis C, Tesoro S, Mendola C, Boninsegni P, Tempia A, Manstretta S, Zamidei L, Gratarola A, Murabito P, Fuggiano L, DI Marco P. Reversal of rocuronium induced neuromuscular block with sugammadex or neostigmine: a large observational study. Acta Anaesthesiol Scand. 2013 Oct;57(9):1138-45. doi: 10.1111/aas.12155. Epub 2013 Jul 14.

  PMID: 23849107 BACKGROUND

• Gaszynski T, Szewczyk T, Gaszynski W. Randomized comparison of sugammadex and neostigmine for reversal of rocuronium-induced muscle relaxation in morbidly obese undergoing general anaesthesia. Br J Anaesth. 2012 Feb;108(2):236-9. doi: 10.1093/bja/aer330. Epub 2011 Oct 19.

  PMID: 22012861 BACKGROUND

• Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Vender JS, Gray J, Landry E, Gupta DK. Intraoperative acceleromyography monitoring reduces symptoms of muscle weakness and improves quality of recovery in the early postoperative period. Anesthesiology. 2011 Nov;115(5):946-54. doi: 10.1097/ALN.0b013e3182342840.

  PMID: 21946094 BACKGROUND

• Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear T, Vender JS, Gray J, Landry E. Postoperative residual neuromuscular blockade is associated with impaired clinical recovery. Anesth Analg. 2013 Jul;117(1):133-41. doi: 10.1213/ANE.0b013e3182742e75. Epub 2013 Jan 21.

  PMID: 23337416 BACKGROUND

• Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. doi: 10.1034/j.1399-6576.2002.460801.x.

  PMID: 12190791 BACKGROUND

• White H, Black RJ, Jones M, Mar Fan GC. Randomized comparison of two anti-emetic strategies in high-risk patients undergoing day-case gynaecological surgery. Br J Anaesth. 2007 Apr;98(4):470-6. doi: 10.1093/bja/aem001. Epub 2007 Feb 22.

  PMID: 17317757 BACKGROUND

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Vanitha Sivanaser, M.Med Anaes (UM)

  Kuala Lumpur General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: June 9, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 4, 2018

Record last verified: 2018-10