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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 4 Study of Optimal Relaxation With Rocuronium Infusion Followed by Rapid Reliable Reversal With Sugammadex: A Comparison With Conventional Practice

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 intraope

    Detailed Summary:

    Epidural will be established before induction of a standard balanced general anesthesia. After the epidural, they will be randomized into 2 groups, the CI-Sugammadex group and the IB-Neostigmine group.

    Intra operative analgesia will be achieved with epidural boluses. Adjuvant drugs were administered as per routine clinical practice and their use compared between the groups.

    For patients randomized to the CI-Sugammadex group, intravenous infusion of 0.3 mg/kg/hr (organon product insert) will be administered 30 minutes after the intubation dose or the return of PTC, whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/hr if PTC is > or < than 1-2 and adequate muscle relaxation is maintained throughout the surgery. A dose of Sugammadex (4 mg/kg) will be administered at the end of the surgery (last stitch).

    For patients allocated to IB-Neostigmine group, a bolus of Rocuronium at a dose of 10mg will be administered after reappearance of TOFC > 2 and depth of neuromuscular blockade will be maintained at TOFC of 1-2. At the end of surgery, a dose of Neostigmine (50mcg/kg) will be given at the reappearance of TOFC of 2.

    Rescue boluses of Rocuronium will be given if clinically indicated regardless of the depth of neuromuscular block appear on the TOF-watch.

    The patient will be excluded if his/her epidural fail to function and full dose of opioid is needed intra operatively for analgesia. Patients whose surgery ends before return of the first PTC 1-2 in CI-Sugammadex group or TOFC 2 in IB-Neostigmine group will also be excluded as drop outs

    Sponsor: Hospital Sultanah Aminah Johor Bahru

    Current Primary Outcome: 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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
    • 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
    • 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%


    Original Secondary Outcome: Same as current

    Information By: Hospital Sultanah Aminah Johor Bahru

    Dates:
    Date Received: February 15, 2012
    Date Started: February 2012
    Date Completion:
    Last Updated: August 6, 2015
    Last Verified: August 2015