Comparison of 3 commonly used anaesthetic drugs - Ketamine, Midazolam and Pethidine, given in 3 different combinations, administered via intravenous route to prevent post spinal shivering

Phase 2/3

Recruiting

• Conditions: shivering post neuraxial anaesthesia

• Registration Number: CTRI/2018/01/011430
• Lead Sponsor: Kasturba Medical College

Brief Summary

Shivering is a common complaint after spinal anaesthesia. It has potential hazards. So in my thesis I aim to prevent post spinal anaesthesia shivering by using 3 drug combinations which includes Ketamine, Pethidine, Midazolam in one group; Ketamine and Midazolam in the second group ; Pethidine and Midazolam in the third group. I will be comparing the efficacy of each group In preventing the same. At the same time also compare incidence of adverse effects in each group. I will be measuring the body core temperature = tympanic temperature and skin surface temperature = axillary temperature.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-04
• Last Update Posted: 2018-12-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

ASA physical status 1 and 2 patients who are scheduled for elective lower abdominal and lower limb surgeries under spinal anaesthesia.

Exclusion Criteria

• Patient refusal, Severe systemic disorders like diabetes mellitus, hypertension, cardiopulmonary disease, etc.
• Body mass index of ≥30 kg/m2, Known history of alcohol or substance abuse.
• Renal insufficiency, Peptic ulcer disease, Thyroid disease, Psychiatric disorder, Pregnancy, Acute infections e.g. upper respiratory tract infection or urinary tract infection etc., and fever due to any other cause.
• Allergy to any of the study drugs and all known contraindications to spinal anaesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Incidence and grading of intraoperative shivering.	After spinal anaesthesia, every 10 minutes for 60 minutes
2. Core body temperature and body surface temperature	After spinal anaesthesia, every 10 minutes for 60 minutes

Secondary Outcome Measures

Name	Time	Method
1.Measurement of vital signs- HR, Blood pressure, Mean arterial pressure, SPO2.	2. Adverse effects- hypotension, hallucination, nausea and vomiting

Trial Locations

Locations (1)

Wenlock District Hospital; 🇮🇳 Kannada, KARNATAKA, India

Wenlock District Hospital

🇮🇳Kannada, KARNATAKA, India

Dr Lakshmi Sagar V

Principal investigator

9008610994

lakshmisagar.v@gmail.com