Skip to content

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

Comparison of prophylactic use of three combinations of Ketamine, Midazolam and Pethidine for prevention of shivering during regional anaesthesia.

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011430
Enrollment
120
Registered
2018-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- shivering post neuraxial anaesthesia

Interventions

Intervention1: Ketamine- 0.25mg/kg via IV route Midazolam- 5mcg/kg via IV route Pethidine- 0.35mg/kg via IV route: All the 3 drugs are given as a bolus dose once immediately after spinal anaesthesia.

Sponsors

Kasturba Medical College
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1.Incidence and grading of intraoperative shivering. 2. Core body temperature and body surface temperatureTimepoint: After spinal anaesthesia, every 10 minutes for 60 minutes

Secondary

MeasureTime frame
1.Measurement of vital signs- HR, Blood pressure, Mean arterial pressure, SPO2. 2. Adverse effects- hypotension, hallucination, nausea and vomitingTimepoint: Every 5 minutes for 30 minutes

Countries

India

Contacts

Public ContactDr Lakshmi Sagar V

Kasturba Medical College, Mangalore, Manipal University

pkaimar@yahoo.com9880094661

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026