Deep Neuromuscular Block for Laparoscopic Surgery

NCT03034577 | Completed Phase 4 Results

• 1 other identifier: 2016.343
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 4

Brief Summary

Trial summary: deep neuromuscular block is proposed as a technique to improve operative conditions for laparoscopy. Early clinical data would suggest that there may also be patient benefits beyond the operative period related to lower intra-abdominal pressure, and improved surgical exposure. In order to safely conduct deep neuromuscular blockade, it is essential to use Sugammadex to reverse the neuromuscular block. Conventional practice is to provide moderate neuromuscular block and reverse with neostigmine. It is not possible to safely reverse deep neuromuscular block using neostogmine, as the majority of block must have worn off for neostigmine to be effective. in order to identify whether deep neuromuscular block improves quality of recovery after surgery, the investigators will conduct a randomised trial of deep versus moderate neuromuscular block, whilst minimising variance in other anaesthetic techniques and drugs used. the outcome measured will be the post-operative quality of recovery over multiple time periods using the Postoperative Quality of Recovery Scale (PostopQRS). 350 patients will be enrolled over 4 centres.

Conditions

Laparoscopy; Anesthesia Recovery Period

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Recovered Cognitively at 1 Week

  The primary outcome will be the cognitive domain at 1 week after surgery, when it is expected that most of the acute inflammation will have resolved, and analgesia requirements minimal.

  1 week

Secondary Outcomes (5)

• Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation

  3 months

• Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation

  6 hours

• Duration of Anesthesia From Induction to Cessation of the Anesthetic

  Up to 6 hours

• Number of Participants Categorized by Level of Surgical Satisfaction

  2 hours

• Duration of Hospital Length of Stay

  3 days

Study Arms (2)

ModNMB

ACTIVE COMPARATOR

Moderate Neuromuscular block: participants will receive moderate neuromuscular blockade with rocuronium aiming for TOF 0-2 twitches, with neostigmine reversal when the TOF at least 3 twitches. The depth of neuromuscular block may be reduced after completion of the majority of surgical excision to TOF 3 or more Neostigmine

Drug: Neostigmine

DeepNB

ACTIVE COMPARATOR

Deep Neuromuscular block: participants will receive DNB aiming for a post tetanic count of 1-2, which will be maintained until removal of the laparoscopic ports, with reversal using sugammadex

Drug: Sugammadex

Interventions

Sugammadex DRUG

Reversal of neuromuscular block Sugammadex dosage will be adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. Dosage will be 4mg/kg if TOF = 0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.

DeepNB

Neostigmine DRUG

Neostigmine 50 micrograms/kg coupled with atropine 20 micrograms/kg or glycopyrrolate 5 micrograms/kg, to a maximum dose of neostigmine of 5.0 mg. The neostigmine should not be administered until the TOF has at least 3 twitches present.

ModNMB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants
• operative gynecological or abdominal surgery
• receiving general anesthesia
• Operation expected to exceed1 hour duration
• Participants must speak sufficient English to answer the survey questions

You may not qualify if:

• Participants undergoing diagnostic laparoscopy only
• Participants \<18 years of age
• Current pregnancy
• Known allergy to rocuronium, neostigmine or sugammadex, or desflurane

Sponsors & Collaborators

• University of Melbourne: lead
• Melbourne Health: collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator
• Royal Hospital For Women: collaborator
• Northpark Private Hospital: collaborator

Study Sites (4)

Northpark Private Hospital

Bundoora, Victoria, 3083, Australia

Location

Melbourne Health

Parkville, Victoria, 3050, Australia

Location

The Royal Womens Hospital

Parkville, Victoria, 3050, Australia

Location

Victorian Comprehensive Cancer Centre

Parkville, Victoria, 3050, Australia

Location

Related Publications (1)

• Boggett S, Chahal R, Griffiths J, Lin J, Wang D, Williams Z, Riedel B, Bowyer A, Royse A, Royse C. A randomised controlled trial comparing deep neuromuscular blockade reversed with sugammadex with moderate neuromuscular block reversed with neostigmine. Anaesthesia. 2020 Sep;75(9):1153-1163. doi: 10.1111/anae.15094. Epub 2020 May 12.

  PMID: 32395901 DERIVED

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: Prof Colin Royse
• Organization: The University of Melbourne

Colin.Royse@unimelb.edu.au

+61408467548

Study Officials

• Colin Royse, MD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 27, 2017
• Study Start: June 16, 2017
• Primary Completion: February 15, 2019
• Study Completion: April 1, 2019
• Last Updated: April 22, 2020
• Results First Posted: October 21, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)