Comparison of Prophylactic Use of Tramadol Versus Ketamine for Prevention of Post Spinal Anesthesia Shivering

Not Applicable

Completed

• Conditions: Shivering
• Interventions: Drug: Tramadol; Drug: Ketamine

• Registration Number: NCT07043049
• Lead Sponsor: Syed Muhammad Abbas

Brief Summary

The goal of this clinical trial is to compare the effectiveness of tramadol versus ketamine in preventing shivering after spinal anesthesia in adult patients (ages 20-65) undergoing elective lower abdominal or inguinoscrotal surgeries.

The main questions it aims to answer are:

* Does prophylactic intravenous tramadol reduce the incidence and severity of shivering more effectively than ketamine after spinal anesthesia?

* Are there differences in side effects, such as sedation or nausea, between tramadol and ketamine?

Researchers will compare the tramadol group to the ketamine group to see which drug is more effective and safer for shivering prevention.

Participants will:

* Be randomly assigned to receive either tramadol (1 mg/kg) or ketamine (0.5 mg/kg) five minutes after spinal anesthesia.

* Have their shivering severity assessed at 15, 30, 45, and 60 minutes using a standardized scale.

* Be monitored for sedation, nausea, and other possible side effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-29
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2025-05-28
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Patients aged 20 to 65 years,
2. American Society of Anesthesiologists (ASA) Physical Status I or II, and
3. Scheduled for elective lower abdominal or inguinoscrotal surgeries
4. Under spinal anesthesia were included

Exclusion Criteria

1. Thyroid or neuromuscular disorders,
2. Pregnant
3. History of chronic sedative or narcotic use,
4. Requiring intraoperative blood transfusion
5. Had a baseline body temperature greater than 38°C or less than 36°C,
6. Undergoing transurethral resection of the prostate (TURP).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol Group	Tramadol	Patients in this group receive intravenous tramadol 1 mg/kg five minutes after the administration of spinal anesthesia. The intervention is administered in a double-blind manner using identical syringes prepared by an independent anesthesiologist.
Ketamine Group	Ketamine	Patients in this group receive intravenous ketamine 0.5 mg/kg five minutes after spinal anesthesia, using identical administration procedures to maintain blinding.

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Post-Spinal Anesthesia Shivering	Up to 60 minutes post spinal anesthesia	The incidence and severity of shivering will be assessed using the Bedside Shivering Assessment Scale (BSAS) at 15, 30, 45, and 60 minutes following the administration of spinal anesthesia.; BSAS Grading: * 0 = No shivering; * 1 = Piloerection or peripheral vasoconstriction without visible shivering; * 2 = Visible muscular activity confined to one muscle group; * 3 = Gross muscular activity involving the entire body

Secondary Outcome Measures

Name	Time	Method
Sedation Score	Up to 60 minutes post spinal anesthesia	Sedation will be measured using the Ramsay Sedation Scale (RSS) at 15, 30, 45, and 60 minutes post spinal anesthesia.; RSS scores range from 1 (anxious, agitated) to 6 (no response). Median and interquartile ranges will be calculated for each group.
Incidence of Postoperative Nausea and Vomiting (PONV)	Up to 60 minutes post spinal anesthesia	PONV will be assessed using the PONV Impact Scale at 15, 30, 45, and 60 minutes post spinal anesthesia. Presence or absence will be recorded at each time point.

Trial Locations

Locations (2)

Sindh Institute of Urology and Transplantation; 🇵🇰 Karachi, Sindh, Pakistan

Syed Muhammad Abbas; 🇵🇰 Karachi, Sindh, Pakistan