Evaluation of Atracurium-vecuronium Combination in Laparosocpic Surgery

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.

Conditions

• Patients Undergoing Laparoscopic Surgery

Interventions

DRUG

Vecuronium

A top-up dose of vecuronium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count.

DRUG

Atracurium

A top-up dose of vecuronium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count.

DRUG

Vecuronium + Atracurium

A top-up dose of vecuronium + atracurium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count.

Sponsors & Collaborators

• Sir Ganga Ram Hospital

  lead OTHER

Principal Investigators

• Amitabh Dutta, MD,PGDHR · Sir Ganga Ram Hospital

• Subhash Gupta, MD · Sir Ganga Ram Hospital

• Savitar Malhotra, MD · Sir Ganga Ram Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-20

Primary Completion

2018-10-25

Completion

2018-10-25

Countries

• India

Study Locations