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

Neuromuscular Blockade Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02794714
• Other study ID #: CVL#123
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2018
• Source: Kuala Lumpur General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kuala Lumpur General Hospital	Merck Sharp & Dohme Corp.

References & Publications (15)

Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Apr 21. Review. — View Citation

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. — View Citation

Geldner G, Niskanen M, Laurila P, Mizikov V, Hübler 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Feb 22. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Deep block versus Moderate block: Patient satisfaction score	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
Secondary	Deep block versus Moderate block: Pain score	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
Secondary	Deep block versus Moderate block: PONV Score	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