Optimal Relaxation Technique for Laparotomies With Rocuronium Infusion Followed by Sugammadex Reversal (ProjectO5Rs)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Hospital Sultanah Aminah Johor Bahru
Sponsor:
Information provided by (Responsible Party):
Maria Lee, Hospital Sultanah Aminah Johor Bahru
ClinicalTrials.gov Identifier:
NCT01539044
First received: February 15, 2012
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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

Condition Intervention Phase
Underdosing of Skeletal Muscle Relaxants for Laparotomy
Reversal of Skeletal Muscle Relaxant
Drug: Neostigmine, atropine
Drug: Sugammadex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Optimal Relaxation With Rocuronium Infusion Followed by Rapid Reliable Reversal With Sugammadex: A Comparison With Conventional Practice

Resource links provided by NLM:


Further study details as provided by Hospital Sultanah Aminah Johor Bahru:

Primary Outcome Measures:
  • speed of reversal [ Time Frame: patient monitored till return of full muscle power usually within 30 mins ] [ Designated as safety issue: No ]
    Time from start of administration of reversal agent to recovery of the T4/T1 ratio to 0.9.


Secondary Outcome Measures:
  • Vital signs, i.e. heart rate and blood pressure [ Time Frame: first 24 hours of post op period ] [ Designated as safety issue: Yes ]
    pre-reversal, post-reversal, recovery and post-anesthetic visit

  • intraoperative events [ Time Frame: throughout the operation averagely 3 hours ] [ Designated as safety issue: No ]
    events suggestive of inadequate paralysis during surgery, a composite incidents of movement, coughing, bucking, breathing against ventilator or surgeon complaining of tight abdomen

  • incidence of residual neuromuscular blockade [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    composite occurrence of clinical signs of residual muscle weakness like diplopia, ptosis, non sustained head lift, T4/T1 ratio less than 90%


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IB-neostigmine
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
0.05 mg/KG NEOSTIGMINE AND 0.02 MG/ KG ATROPINE at TOF 2
Experimental: CI-Sugammadex
subject will be given continuous infusion of rocuronium and reversal of sugammadex at the end of surgery at PTC 1-2
Drug: Sugammadex
4 mg/kg sugammadex will be given stat at the end of surgery at PTC 1-2
Other Name: Bridion

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539044

Contacts
Contact: Dr Maria HS lee, MMed (Anaes) 60127092163 mariahslee@gmail.com
Contact: Dr Muhammad Rahmat Ali Hassan, MD ( UKM) espadano4@gmail.com

Locations
Malaysia
Hospital Sulatanah Aminah Recruiting
Johor Bahru, Johor, Malaysia, 80100
Contact: Dr Maria HS lee, MMed ( Anaes)       mariahslee@gmail.com   
Contact: Dr Azmiza Maharani , MMed ( Anaes)       azmiza1017@gmail.com   
Sub-Investigator: Dr Muhammad Rahmat Ali Hassan, MD (UKM)         
Sub-Investigator: Dr Azmiza Maharani, MMed ( Anaes)         
Sponsors and Collaborators
Hospital Sultanah Aminah Johor Bahru
Investigators
Principal Investigator: Dr Maria HS lee, MMed(Anaes) Clinical research Centre Johor, Malaysia
  More Information

No publications provided

Responsible Party: Maria Lee, Consultant Anaesthesiologist, principal investigator, Hospital Sultanah Aminah Johor Bahru
ClinicalTrials.gov Identifier: NCT01539044     History of Changes
Other Study ID Numbers: NMRR-10-1323-7843, NMRR-10-1323-7843
Study First Received: February 15, 2012
Last Updated: September 5, 2012
Health Authority: Malaysia: Institutional Review Board

Keywords provided by Hospital Sultanah Aminah Johor Bahru:
reversal
muscle relaxant
sugammadex

Additional relevant MeSH terms:
Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atropine
Neostigmine
Rocuronium
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors
Parasympathomimetics

ClinicalTrials.gov processed this record on August 01, 2014