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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Sultanah Aminah Johor Bahru
• Treatments: Atropine; Neostigmine; Rocuronium

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.