Use of Iv Tramadol and Ketamine for Prevention of Post Spinal Anesthesia Shivering

Phase 3

Recruiting

• Conditions: Shivering, Spinal Anesthesia
• Interventions: Drug: Ketamine only; Drug: Tramadol

• Registration Number: NCT06722742
• Lead Sponsor: Liaquat National Hospital & Medical College

Brief Summary

\*Ketamine:\* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response.

- \*Tramadol:\* Tramadol is a pain medication that can also help reduce shivering. It works by affecting the brain's temperature regulation centers, which helps to reduce the shivering response.

Detailed Description

Post-spinal shivering is when a patient starts shaking or shivering after receiving spinal anesthesia. This can be uncomfortable and even scary for the patient.

Using ketamine and tramadol to reduce post-spinal shivering can have several benefits, including:

* Reduced discomfort and anxiety for the patient

* Improved patient satisfaction

* Reduced need for additional medications or interventions

* Faster recovery times

Study Timeline

• Study Start: 2024-09-30
• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• Pateint for elective cesarean section
• Age 18 to 40 years
• ASA 1 and 2

Exclusion Criteria

• ASA 2 and 3
• Cesarean section requiring general anesthesia
• Hypersensitivity to Ketamine, Tramadol and Opiods
• History of cardiovascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group K	Ketamine only	Group K receive Inj: ketamine
Group T	Tramadol	Group T receive Inj: Tramadol

Primary Outcome Measures

Name	Time	Method
Shivering	20 minutes to 12 hours	Scale validated by crossley and mahajan Grade 0: No shivering Grade 1: Piloerection, peripheral vasoconstriction, peripheral cyanosis, or mild fasciculation of the face or neck, but no visible muscle activity Grade 2: Visible muscle activity in one muscle group Grade 3: Visible muscle activity in more than one muscle group Grade 4: Gross muscle activity involving the entire body

Trial Locations

Locations (1)

Liaquat National Hospital and Medical College; 🇵🇰 Karachi, Sindh, Pakistan