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Clinical Trials/CTRI/2023/12/060528
CTRI/2023/12/060528Active, not recruitingPhase 3

"Comparison of intravenous pretreatment with dexmeditomedine, ketamine and preservative free lignocaine in alleviating propofol injection pain -- A prospective randomized study."

Dr Sanju Ashokkumar1 site in 1 country150 target enrollmentStarted: January 1, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Active, not recruiting
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
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)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients who are willing to participate in the study
  • Patients undergoing surgeries that require general anaesthesia with propofol as induction agent
  • Age group of 18-60 of either sex
  • 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.

Outcomes

Primary Outcomes

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)

Time Frame: 0 seconds, 30 seconds and 60 seconds

None (0) - No response to questioning

Time Frame: 0 seconds, 30 seconds and 60 seconds

Mild (1) - Pain reporting in response to questioning only

Time Frame: 0 seconds, 30 seconds and 60 seconds

Moderate (2) - Pain reporting in response to questioning and or pain reported spontaneously without questioning

Time Frame: 0 seconds, 30 seconds and 60 seconds

Severe (3) - Strong vocal response accompanied by facial grimace, arm withdrawals or tears

Time Frame: 0 seconds, 30 seconds and 60 seconds

Secondary Outcomes

  • The hemodynamic variability in patients upon injecting these study agents.(0 seconds and 1 minute)

Investigators

Sponsor
Dr Sanju Ashokkumar
Sponsor Class
Other [self]

Study Sites (1)

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