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Deep Neuromuscular Block for Laparoscopic Surgery

NCT03034577 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2020-04-22

Study results available
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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

Interventions

DRUG

Sugammadex

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.

DRUG

Neostigmine

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.

Sponsors & Collaborators

  • Melbourne Health

    collaborator OTHER

  • Peter MacCallum Cancer Centre, Australia

    collaborator OTHER

  • Royal Hospital For Women

    collaborator OTHER

  • Northpark Private Hospital

    collaborator UNKNOWN

  • University of Melbourne

    lead OTHER

Principal Investigators

  • Colin Royse, MD · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2019-02-15
Completion
2019-04-01

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03034577 on ClinicalTrials.gov