To compare the effects of cisatracurium and atracurium on levels of tryptase, Ig E and absolute eosinophil count in adult patients undergoing general anesthesia for elective surgery.

Completed

• Conditions: Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures,

• Registration Number: CTRI/2021/09/036550
• Lead Sponsor: ABVlMS and Dr RML hospital

Brief Summary

This is a  randomized prospective observational study in which comparison will be done on effects of cisatracurium and atracurium upon trypase levels , Ig E levels and absolute eosinophil counts in adult patients undergoing general anesthesia for elective surgery in Dr RML hospital New Delhi . The outcome measures will be tryptase levels, IgE levels, absolute eosinophil count , hemodynamic parameters and clinical side effects profile of the patients before induction, one and two hours after giving first dose of study drug and at the time of any side effects if any.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-10
• Study Completion: 2022-05-31
• Last Update Posted: 2023-09-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Consenting adult patients with ASA Grade 1/2 and modified Mallampati grade 1/2.

Exclusion Criteria

• Patients with anticipated difficult airway.
• Patients with peripheral neuropathy, diabetes mellitus, neuromuscular disorders and myopathies.
• Patients on antibiotics (e.g., aminoglycosides, tetracyclins, bacitracin, lincomycin, clindamycin, colistin).
• Patients on drugs like Magnesium sulphate, lithium, procainamide and quinidine.
• Patients with history of atopy and asthma.
• Patients with known allergy to any of the drugs involved in study.
• pregnant patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients tryptase levels,IgE levels, absolute eosinophil count, hemodynamic parameters (heart rate and SBP/DBP), cilinical side effects ( flushing of skin, rashes, hypotension, tachycardia, bronchospasm, anaphylaxis, arrhythmias)	Blood samples will be taken before induction , one and two hour after giving first dose of study drug and additional sample if and when any side effects occurs.

Trial Locations

Locations (1)

ABVIMS and Dr RML Hospital,New Delhi, 110001.; 🇮🇳 Delhi, DELHI, India

ABVIMS and Dr RML Hospital,New Delhi, 110001.

🇮🇳Delhi, DELHI, India

Neha Kumari

Principal investigator

8826803515

neha11j94@gmail.com