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

NCT01539044 | Completed Phase 4 DMC

• 1 other identifier: NMRR-10-1323-7843
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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:

• PTC 1-2 in CI-Sugammadex group
• TOFC ≥2 in IB-Neostigmine group
• Incidence of residual neuromuscular blockade (T4/T1 ratios \< 0.9)
• 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

Keywords

reversal; muscle relaxant; sugammadex

Outcome Measures

Primary Outcomes (1)

• speed of reversal

  Time from start of administration of reversal agent to recovery of the T4/T1 ratio to 0.9.

  patient monitored till return of full muscle power usually within 30 mins

Secondary Outcomes (3)

• Vital signs, i.e. heart rate and blood pressure

  first 24 hours of post op period

• intraoperative events

  throughout the operation averagely 3 hours

• incidence of residual neuromuscular blockade

  1 hour

Study Arms (2)

IB-neostigmine

ACTIVE COMPARATOR

subject will be given intermittent bolus of rocuronium during the surgery and reversal of neostigmine at the end of surgery at TOF 2

Drug: Neostigmine, atropine

CI-Sugammadex

EXPERIMENTAL

subject will be given continuous infusion of rocuronium and reversal of sugammadex at the end of surgery at PTC 1-2

Drug: Sugammadex

Interventions

Neostigmine, atropine DRUG

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

IB-neostigmine

Sugammadex DRUG

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

Also known as: Bridion

CI-Sugammadex

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 - 75 years old; ASA I - III;
• Elective or Semi-Emergency Laparotomy under general anaesthesia needed tracheal intubation and muscle relaxation;

You may not qualify if:

• Severe renal impairment (CrCL \< 30 ml/ min);
• Severe hepatic impairment;
• BMI \> 30 kg m2;
• Known or suspected neuromuscular disorders;
• Allergies to narcotics, muscle relaxant, benzodiazepine or other medication used during general anesthesia;
• Hypersensitivity to the active substance or to any of the excipients
• Patient where difficult intubation was anticipated during physical examination;
• Patient who is contraindicated to epidural analgesia;
• Patient on aminoglycoside antibiotics, anticonvulsants or magnesium, as it will interfere with the action of rocuronium;
• Female patient who were pregnant, breastfeeding, or of child bearing potential and not using adequate contraception;
• Patient with poor GCS and mental derangement who is unable to give consent.

Sponsors & Collaborators

• Hospital Sultanah Aminah Johor Bahru: lead

Study Sites (1)

Hospital Sulatanah Aminah

Johor Bahru, Johor, 80100, Malaysia

Location

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

Neostigmine; Atropine; Sugammadex

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Dr Maria HS lee, MMed(Anaes)

  Clinical research Centre Johor, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist, principal investigator

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 27, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

MY (1)