NCT01539044.

Trial name or title	Optimal relaxation technique for laparotomies with rocuronium infusion followed by sugammadex reversal (ProjectO5Rs)
Methods	Allocation: randomized Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: double‐blind (participant, caregiver, outcomes assessor) Primary purpose: treatment
Participants	Enrollment: 49 Inclusion criteria: Age 18 to 75 years, ASA I to 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 Allergy to narcotics, muscle relaxants, benzodiazepine, or other medication used during general anaesthesia Hypersensitivity to active substance or to any of the excipients Difficult intubation anticipated during physical examination Contraindication to epidural analgesia Aminoglycoside antibiotics, anticonvulsants, or magnesium, as these will interfere with the action of rocuronium Pregnant, breastfeeding, or woman of child‐bearing potential who is not using adequate contraception Poor GCS and mental derangement, unable to give consent
Interventions	Active comparator: IB‐neostigmine Participant will be given intermittent bolus of rocuronium during surgery and reversal of neostigmine at completion of surgery at TOFR 2 Experimental: CI‐sugammadex Participant will be given continuous infusion of rocuronium and reversal of sugammadex at completion of surgery at PTC 1 to 2
Outcomes	Primary outcome measures: Speed of reversal [Time Frame: participant monitored until return of full muscle power, usually within 30 minutes] [Designated as safety issue: no ]. Time from start of administration of reversal agent to recovery of T4/T1 ratio to 0.9 Secondary outcome measures: Vital signs, i.e. heart rate and blood pressure [Time Frame: first 24 hours of postop period] [Designated as safety issue: yes] Pre‐reversal, post‐reversal, recovery, and post‐anaesthetic visit intraoperative events [Time Frame: throughout the operation, on average 3 hours] [Designated as safety issue: no] Events suggestive of inadequate paralysis during surgery, a composite incidence 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 < 90%
Starting date	February 2012
Contact information	Principal investigator: Dr. Maria HS lee, MMed(Anaes), Clinical Research Centre, Johor, Malaysia
Notes	This study has been completed. No study data have been published to the best of our knowledge