Use of multiple drugs to reduce pain of propofol injection

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/11/047602
• Lead Sponsor: Mysore Medical college and Research Institute

Brief Summary

Propofol, a short acting intravenous anaesthetic agent is used extensively because of its smooth induction and rapid recovery.  It is the agent of choice for day care anaesthesia, total intravenous anaesthesia, for sedation in intensive care units, and as an agent for maintenance of anaesthesia.   However, pain on intravenous injection is a major drawback of propofol. Pain is acknowledged reaction of propofol administration. ..Propofol can directly inflame the skin, mucous membranes and venous intima and can instantly lead to nociceptor and free nerve ending stimulation. Pain post propofol administration can be disquieting and is known to affect between 28% and 90% of patients. Injection pain is associated with the concentration of the aqueous free propofol. It has been attributed to the contact between the aqueous phase and the venous intima. It has been advocated that propofol causes release of bradykinin via activation of the kallikrein-kinin system, leading to venous dilation and hyperpermeability, enhancing the contact between the aqueous phase and free nerve endings, resulting in deferred pain within 10-20 seconds. Various pharmacological (e.g., pretreatment with lignocaine, ondansetron, granisetron, palonosetron, magnesium sulphate, nitroglycerine, ramosetron, metoclopramide, nitroglycerine, diluting propofol with 5% dextrose and using medium and long chain triglycerides) and non-pharmacological (e.g., injecting propofol into large vein, cooling of propofol, warming of propofol, adding saline to propofol or varying the rate of propofol infusion) methods have been used with variable results and the research for the ideal agent to decrease pain on propofol injection is still going on. Pre-treatment with lignocaine with venous occlusion was found to decrease the incidence and severity of pain on injection of propofol. Lignocaine hydrochloride due to its membrane stabilising action along with blocking of sodium channels was well accepted. Ondansetron a 5HT3 antagonist, widely used as an antiemetic drug which has got a local anaesthetic property it is also used as pretreatment for alleviation of pain on propofol injection. Ramosetron is one of the potent 5HT3 receptor antagonist commonly used as an antiemetic and has been found to be effective in prevention of early Post operative nausea and vomiting compared to ondansetron. Metoclopramide shares structural and physicochemical properties with lignocaine and is a weak local anaesthetic. It has been shown to be as effective as lignocaine in reducing propofol injection pain. Considering this, the aim of present study is to compare effect of lignocaine, ondansetron, ramosetron and metoclopramide in attenuation of propofol induced pain during the induction of anaesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-12
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1.Patients undergoing elective surgeries under general anaesthesia.
• 2.Belonging to American Society of Anaesthesiologists (ASA) Physical status I or II.
• 3.Patients who are willing to sign written informed consent form.

Exclusion Criteria

• 1.Patients belonging to ASA III and IV physical status.
• 2.Patients with known cardiac disorders, other systemic disorders of lung and liver.
• 5.Those allergic to Propofol and study drugs 6.Those with history of motion sickness 7.History of post- operative nausea and vomiting 8.Patients in nasogastric tube and patients with difficult airway.
• 9.Patient refusal 10.History of taking any analgesic before surgery 11.Neurological deficit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Attenuation of propofol induced pain during induction of anaesthesia.	Pain is assessed at baseline, 5 seconds 10 seconds, 15 seconds, 20 seconds, 25 seconds and 30 seconds during induction of anaesthesia using propofol injection

Trial Locations

Locations (1)

KR Hospital and Cheluvamba Hospital operation theatre; 🇮🇳 Mysore, KARNATAKA, India

KR Hospital and Cheluvamba Hospital operation theatre

🇮🇳Mysore, KARNATAKA, India

Dr VY Srinivas

Principal investigator

9448165082

drsrinivasvy@gmail.com