Evaluation of Atracurium-vecuronium Combination in Laparosocpic Surgery

NCT03371953 | Unknown Phase 4 DMC

• 1 other identifier: EC/10/17/1280
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vecuronium; atracurium; combination

Outcome Measures

Primary Outcomes (1)

• Duration-of-action of the intubating dose

  Duration of action will be calculated from the time the drug is administered till theTOF count is 1 on the accelerometer.

  From the time of administration of (0-hours, baseline) till 60-minutes intraoperatively

Secondary Outcomes (3)

• Onset-of-action of muscle relaxation following intubating dose

  From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively

• Qualitative intubating conditions.

  From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively

• Reversibility of muscle relaxant effect

  From the time of administration of (0-hours, baseline) till 5-minutes post administration

Study Arms (3)

Vecuronium group

ACTIVE COMPARATOR

Vecuronium 0.08 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation

Drug: Vecuronium

Atracurium group

ACTIVE COMPARATOR

Atracurium 0.6 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation

Drug: Atracurium

Vecuronium-Atracurium group

ACTIVE COMPARATOR

Vecuronium 0.04 mg/kg + atracurium 0.3 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation

Drug: Vecuronium + Atracurium

Interventions

Vecuronium DRUG

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.

Vecuronium group

Atracurium DRUG

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.

Atracurium group

Vecuronium + Atracurium DRUG

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.

Vecuronium-Atracurium group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I and II
• Laparoscopic surgeries likely to last for 1 hour duration

You may not qualify if:

• Patient refusal
• ASA physical status III and IV
• History of hypersensitivity to atracurium or vecuronium
• Alcoholism and drug addiction
• Neuromuscular disorders
• Neuropsychiatric patients
• Hepatic and renal disease patients
• Obese patients
• Abnormal airway anatomy
• Risk of oesophageal reflux

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

MeSH Terms

Interventions

Vecuronium Bromide; Atracurium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Amitabh Dutta, MD,PGDHR

  Sir Ganga Ram Hospital

  STUDY CHAIR

• Subhash Gupta, MD

  Sir Ganga Ram Hospital

  STUDY DIRECTOR

• Savitar Malhotra, MD

  Sir Ganga Ram Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amitabh Dutta, MD,PGDHR

CONTACT

00919810848064; duttaamiatbh@yahoo.co.in

Palem Reshmika

CONTACT

00919773587847; reshmika.palem@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient, the attending anaesthesiologist, and the personnel recording the assessment parameters will be blinded to the randomisation sequence and the drug inside the 5-ml solution is supplied in a 5-ml syringe. The study drug for the three group allocation will be contained in a similar 5-ml solution (drug+0.9% saline solution).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant & Professor

Model Details: Patients will be randomly divided into three groups in a 1:1:1 distribution undertaken by a computer-generated random number system. Vecuronium group - 0.08mg/kg vecuronium alone Atracurium group- 0.6mg/kg atracurium alone Vecuronium-atracurium group- 0.04mg/kg vecuronium and 0.3 mg/kg atracurium combination

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: December 13, 2017
• Study Start: December 20, 2017
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: December 14, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)