COMPARISON OF ONSET AND RECOVERY FROM FIRST NEUROMUSCULAR BLOCKADE BETWEEN CISATRACURIUM AND ATRACURIUM

Phase 4

Not yet recruiting

• Conditions: ADULT PATIENTS UNDERGOING SURGICAL PROCEDURES

• Registration Number: CTRI/2019/01/017084
• Lead Sponsor: MGM MEDICAL COLLEGE AND HOSPITAL

Brief Summary

Atracurium and Cisatracurium are two non depolarizingNMB agents with intermediate duration of action belonging to benzylisoquinoliniumgroup.

Atracurium is metabolized by Hofmann degradation andalkaline ester hydrolysis in the plasma and elsewhere in the body. It isassociated with production of tertiary metabolite laudanosine which has slowrenal elimination and crosses blood brain barrier.

Atracurium is associated with dose as well as speed ofinjection dependent histamine release which presents as transient hypotension,tachycardia and facial flushing.

Cisatracurium is a purified form of one of the 10  stereoisomers of atracurium which isapproximately 3 times more potent than atracurium and unlike the parentcompound, is not associated with dose-dependent histamine release in humans.

Cisatracurium undergoes Hofmann elimination but nothydrolysis by plasma esterases. Laudanosine levels are much lower compared toatracurium

.

The primary objective of this study is to compare theonset of neuromuscular blockade and recovery from the first loading dosebetween the two non-depolarizing NMBD, cisatracurium and atracurium in adultpatients undergoing surgical procedures under general anaesthesia.

The secondary objective is to observe the haemodynamicstability and adverse effects in relation to both the NMBDs.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

PATIENTS UNDERGOING ANY SURGICAL PROCEDURE UNDER GENERAL ANAESTHESIA REQUIRING NEUROMUSCULAR BLOCKADE.

Exclusion Criteria

ANTICIPATED DIFFICULT INTUBATION RISK OF ASPIRATION ASA GRADE 3 AND ABOVE HYPERSENSITVITY TO NEUROMUSCULAR BLOCKING AGENTS PATIENTS WITH HEPATIC OR RENAL DISEASE BMI MORE THAN 30.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ONSET OF ACTION	ONSET OF ACTION | HAEMODYNAMIC STABILITY | RECOVERY FROM FIRST LOADING DOSE OF CIS-ATRACURIUM AND ATRACURIUM
HAEMODYNAMIC STABILITY	ONSET OF ACTION | HAEMODYNAMIC STABILITY | RECOVERY FROM FIRST LOADING DOSE OF CIS-ATRACURIUM AND ATRACURIUM
RECOVERY FROM FIRST LOADING DOSE OF CIS-ATRACURIUM AND ATRACURIUM	ONSET OF ACTION | HAEMODYNAMIC STABILITY | RECOVERY FROM FIRST LOADING DOSE OF CIS-ATRACURIUM AND ATRACURIUM

Secondary Outcome Measures

Name	Time	Method
INTUBATING CONDITIONS	ADVERSE REACTIONS

Trial Locations

Locations (1)

MGM MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Aurangabad, MAHARASHTRA, India

MGM MEDICAL COLLEGE AND HOSPITAL

🇮🇳Aurangabad, MAHARASHTRA, India

DR PALAK R BOHRA

Principal investigator

8698032592

palak.leo@gmail.com