Reduction of pain due to propofol by ondansetron or lignocaine - a comparative study

Not Applicable

Recruiting

• Conditions: Pain due to propofol administration

• Registration Number: CTRI/2018/05/013827
• Lead Sponsor: Sri Devaraj Urs Academy of Higher Education and Research

Brief Summary

To reduce pain due to propofol injection, various drugs have been triedsuch as lignocaine, ketorolac, paracetamol, ketamine, magnesium sulfate ortopical nitroglycerine application but complete attenuation of pain due topropofol injection was not observed. Mixing lignocaine withpropofol is most commonly used method for prevention of propofol injection pain. Ondansetron is a selective serotonin receptor antagonist (5-HT3),currently used for the prophylaxis and treatment of postoperative nausea andvomiting. Some studies have demonstrated that ondansetron can produce localanesthetic effect, probably by blocking sodium channels. It blocks theperipheral nociceptive effect of serotonin thus having antinociceptive effect. Ondansetronbinds to the opioid μ receptors and acts as an agonist.Twocomparative studies between lignocaine and ondansetron have been carried out inIndia with variable results and they had recruited 40-50 patients.7,8 Routinely ondansetron is administeredpreoperatively to prevent post-operative nausea and vomiting. Therefore,instead of another drug, ondansetron will be compared with lignocaine to assessthe analgesic effect in larger number of individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 546

Inclusion Criteria

1.Patients of either gender aged between 21- 50 years 2.Patients with body weight of 50-80 Kg 3.Patients undergoing elective surgeryunder general anesthesia 4.Patients belonging to American Society of Anesthesiology (ASA) physical status I and II.

Exclusion Criteria

1.History of allergy to study drugs 2.Pregnant and lactating women 3.Patients receiving analgesics 48 hours before surgery 4.Patients with pain posted for elective surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of ondansetron and lignocaine in reducing pain following propofol injection using Verbal Rating Scale (VRS)	Baseline and 15 seconds after propofol injection intravenoulsy

Secondary Outcome Measures

Name	Time	Method
To assess the adverse effect in both groups using WHO causality assessment and Naranjo probability scales	Study drugs administration to 6 hrs postoperatively

Trial Locations

Locations (1)

Sri Devaraj Urs Medical College; 🇮🇳 Kolar, KARNATAKA, India

Sri Devaraj Urs Medical College

🇮🇳Kolar, KARNATAKA, India

Bhuvana K

Principal investigator

9900383738

drbhuvanak2010@gmail.com