Optimal Relaxation Technique for Laparotomies With Rocuronium Infusion Followed by Sugammadex Reversal (ProjectO5Rs)
|ClinicalTrials.gov Identifier: NCT01539044|
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : August 7, 2015
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:
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
- 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
|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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
subject will be given continuous infusion of rocuronium and reversal of sugammadex at the end of surgery at PTC 1-2
4 mg/kg sugammadex will be given stat at the end of surgery at PTC 1-2
Other Name: Bridion
- 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.
- 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%
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539044
|Hospital Sulatanah Aminah|
|Johor Bahru, Johor, Malaysia, 80100|
|Principal Investigator:||Dr Maria HS lee, MMed(Anaes)||Clinical research Centre Johor, Malaysia|