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Optimal Relaxation Technique for Laparotomies With Rocuronium Infusion Followed by Sugammadex Reversal

NCT01539044 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2015-08-07

No results posted yet for this study

Summary

Muscle relaxation using rocuronium infusion with sugammadex reversal hypothetically provide better quality of muscle relaxation and rapid recovery from anaesthesia compared with intermittent bolus of rocuronium muscle relaxant which is reversed with neostigmine.

50 patients undergoing major laparotomy surgery with predicted surgical time of more than 90 minutes will be randomised into 2 treatment arms: CI-sugammadex \& IB-Neostigmine.

After a bolus of rocuronium given during induction, patients in CI-Sugammadex arm will be started on rocuronium infusion immediately and rate adjusted according to the targeted PTC of 1-2. Patients randomised to IB-Neostigmine will be given boluses of rocuronium at reappearance of TOFC of 2.

At the end of the surgery, the subject will be reversed with either sugammadex or neostigmine at different depth of block, ie PTC 1-2 and TOFC 2 respectively.

Quality of intraoperative relaxation and effectiveness of reversal of the 2 technique, CI-Sugammadex and IB-Neostigmine will be compared with respect to:

1. Time to full reversal (T4/T1 \[TOF\] ratios ≥ 0.9) of neuromuscular blockade from:

* PTC 1-2 in CI-Sugammadex group
* TOFC ≥2 in IB-Neostigmine group
2. Incidence of residual neuromuscular blockade (T4/T1 ratios \< 0.9)
3. Improved quality of intraoperative neuromuscular relaxation by maintaining profound neuromuscular blockade, as reflected by reduced incidence of intraoperative events and high VAS grading of relaxation quality by surgeon

Conditions

  • Underdosing of Skeletal Muscle Relaxants for Laparotomy
  • Reversal of Skeletal Muscle Relaxant

Interventions

DRUG

Neostigmine, atropine

0.05 mg/KG NEOSTIGMINE AND 0.02 MG/ KG ATROPINE at TOF 2

DRUG

Sugammadex

4 mg/kg sugammadex will be given stat at the end of surgery at PTC 1-2

Sponsors & Collaborators

  • Hospital Sultanah Aminah Johor Bahru

    lead OTHER_GOV

Principal Investigators

  • Dr Maria HS lee, MMed(Anaes) · Clinical research Centre Johor, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Malaysia

Study Locations

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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 NCT01539044 on ClinicalTrials.gov