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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01539044
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : August 7, 2015
Information provided by (Responsible Party):
Maria Lee, Hospital Sultanah Aminah Johor Bahru

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:

  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 or disease Intervention/treatment Phase
Underdosing of Skeletal Muscle Relaxants for Laparotomy Reversal of Skeletal Muscle Relaxant Drug: Neostigmine, atropine Drug: Sugammadex Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Primary Outcome Measures :
  1. speed of reversal [ Time Frame: patient monitored till return of full muscle power usually within 30 mins ]
    Time from start of administration of reversal agent to recovery of the T4/T1 ratio to 0.9.

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

  2. intraoperative events [ Time Frame: throughout the operation averagely 3 hours ]
    events suggestive of inadequate paralysis during surgery, a composite incidents of movement, coughing, bucking, breathing against ventilator or surgeon complaining of tight abdomen

  3. incidence of residual neuromuscular blockade [ Time Frame: 1 hour ]
    composite occurrence of clinical signs of residual muscle weakness like diplopia, ptosis, non sustained head lift, T4/T1 ratio less than 90%

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01539044

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Hospital Sulatanah Aminah
Johor Bahru, Johor, Malaysia, 80100
Sponsors and Collaborators
Hospital Sultanah Aminah Johor Bahru
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Principal Investigator: Dr Maria HS lee, MMed(Anaes) Clinical research Centre Johor, Malaysia

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Responsible Party: Maria Lee, Consultant Anaesthesiologist, principal investigator, Hospital Sultanah Aminah Johor Bahru Identifier: NCT01539044     History of Changes
Other Study ID Numbers: NMRR-10-1323-7843
NMRR-10-1323-7843 ( Registry Identifier: National Medical Research Register (NIH Malaysia) )
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Keywords provided by Maria Lee, Hospital Sultanah Aminah Johor Bahru:
muscle relaxant
Additional relevant MeSH terms:
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Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors