A clinical trial to compare the effects of 3 drugs - Dexmeditomedine, Ketamine and Preservative free lignocaine in reducing the pain caused by injection of propofol

Phase 3

Active, not recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/12/060528
• Lead Sponsor: Dr Sanju Ashokkumar

Brief Summary

Propofol is one of the most commonly used induction agents in anaesthesia practice.Due to its sedative and hypnotic properties, its usage in TIVA and procedural sedation has become a common practice. Continous IV infusion of propofol is also used extensively for producing IV sedation, especially in ICU setups.  Its favourable features include quick onset of action, rapidity in causing loss of consciousness, pleasant sleep and quick smooth recovery and no postoperative nausea and vomiting.

It causes pain when given intravenously, the incidence varying from 28% to 98% in adults during induction of anaesthesia. The theories for this pain include activation of plasma kallikrein-kinin system, oil emulsion preparation, osmolality of the solvent used to make the preparation and the pH of the solution. Propofol injection pain can cause sympathetic activation, may induce unwanted apprehension and anxiety, leading to an unpleasant general anaesthesia experience.

Several methods have been tried to attenuate this pain, such as increasing flow rate, injecting it into larger vein, adding various opioids, cooling/dilution of propofol and pre- treatment with other drugs like ondansetron, ephedrine, metaclopramide, nafamostate mesilate, thiopentone sodium etc. The most extensively used method is pretreatment with lignocaine. It reduces pain during propofol injection by its local anaesthetic action and also by stabilising kinin cascade. However, it has a failure rate of 13-32%.

Ketamine, a phencyclidine derivative apart from being a good general anaesthetic agent, also has analgesic and local anaesthetic effects. This can be attributed to its antagonistic action on NMDA receptors, thereby can help in reducing propofol induced pain.

Recently Alpha 2 adrenergic agonists like clonidine have also been known to alleviate propofol injection pain. A more selective alpha 2 adrenergic agonist like dexmeditomedine , which also has analgesic and sedative properties has been researched to combat this pain.

There are limited studies comparing these drugs for reduction of propofol pain. In this study, we propose to compare intravenous dexmeditomedine , intravenous ketamine and intravenous preservative free lignocaine in reducing propofol injection pain.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-12-18
• Study Start: 2024-01-01

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients who are willing to participate in the study 2.
• Patients undergoing surgeries that require general anaesthesia with propofol as induction agent 3.
• Age group of 18-60 of either sex 4.
• American society of anaesthesiologist (ASA) physical status I and II.

Exclusion Criteria

1.History of drug allergy 2.Patients who dont fit in the age/ ASA criteria 3.History of psychiatric disorder 4.History of seizure disorder 5.History of substance abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of intravenous dexmeditomedine ,ketamine and preservative free lignocaine in reducing the Intensity of pain upon injection of propofol graded on a four point scale (0-3)	0 seconds, 30 seconds and 60 seconds
None (0) - No response to questioning	0 seconds, 30 seconds and 60 seconds
Mild (1) - Pain reporting in response to questioning only	0 seconds, 30 seconds and 60 seconds
Moderate (2) - Pain reporting in response to questioning and or pain reported spontaneously without questioning	0 seconds, 30 seconds and 60 seconds
Severe (3) - Strong vocal response accompanied by facial grimace, arm withdrawals or tears	0 seconds, 30 seconds and 60 seconds

Secondary Outcome Measures

Name	Time	Method
The hemodynamic variability in patients upon injecting these study agents.	0 seconds and 1 minute

Trial Locations

Locations (1)

McGANN TEACHING DISTRICT HOSPITAL; 🇮🇳 Shimoga, KARNATAKA, India

McGANN TEACHING DISTRICT HOSPITAL

🇮🇳Shimoga, KARNATAKA, India

Dr Sanju Ashokkumar

Principal investigator

9663149347

sanjuashokkumar@yahoo.com