drugset / Trial / NCT03371953

Evaluation of Atracurium-vecuronium Combination in Laparosocpic Surgery

NCT03371953

Phase 4 Unknown 48 enrolled Sir Ganga Ram Hospital
RandomizedParallel-groupTriple-blindOther

Summary

Non-depolarising muscle relaxants are routinely employed to provide skeletal muscle relaxation during general anaesthesia (GA). Generally investigators use one or the other type of relaxant agent for this purpose and they are categorised based on their duration-of-action. Atracurium and vecuronium are two common muscle relaxant used during GA. They have an intermediate duration of action (around 40 minutes). Though they are effective relaxants and easy to reverse with reversal agents after the surgery, in case of the common laparoscopy procedures lasting an hour, they are relatively inefficient. There is evidence that when these agents are combined together (in 1:1 ratio), the duration-of-action, and reversibility improves. To render atracurium and vecuronium more efficient with laparoscopic surgery, the proposed study is aimed to evaluate the effects of combining 1/2 the respective standard doses of atracurium and vecuronium given together, in terms of its effect on the onset of block, duration-of-action, and reversibility of the neuromuscular blockade in adults undergoing laparoscopic surgery under GA. The study will be conducted with objective assessment parameter evaluation by TOF Watch SX (Organon, Teknica BV, Boxtel, The Netherlands), which will be used for facilitating institution, control, and monitoring the neuromuscular blockade during surgery. The objective of this study is to evaluate the additive effect of atracurium-vecuronium combination and profile its impact in patients undergoing laparoscopic surgery, especially in terms of increase in duration-of-action of muscle relaxation with the combination of drugs, when compared to respective individual drugs.

Timeline

Start
2017-12-20
Primary completion
2018-10-25
Completion
2018-10-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atracurium Small molecule 0.3 mg/kg
Comparator Atracurium Small molecule 0.6 mg/kg
Comparator Vecuronium Small molecule 0.04 mg/kg
Comparator Vecuronium Small molecule 0.08 mg/kg

Indications

No indication recorded.