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

NCT07043049 | Completed Phase 3

• 1 other identifier: SIUT-ERC-2021/A-326
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

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.

Conditions

Shivering

Keywords

Shivering; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Post-Spinal Anesthesia Shivering

  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

  Up to 60 minutes post spinal anesthesia

Secondary Outcomes (2)

• Sedation Score

  Up to 60 minutes post spinal anesthesia

• Incidence of Postoperative Nausea and Vomiting (PONV)

  Up to 60 minutes post spinal anesthesia

Other Outcomes (2)

• Rescue Analgesic Use

  Within 60 minutes post spinal anesthesia

• Adverse Events Monitoring

  Intraoperative and up to 60 minutes post spinal anesthesia

Study Arms (2)

Tramadol Group

EXPERIMENTAL

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.

Drug: Tramadol

Ketamine Group

ACTIVE COMPARATOR

Patients in this group receive intravenous ketamine 0.5 mg/kg five minutes after spinal anesthesia, using identical administration procedures to maintain blinding.

Drug: Ketamine

Interventions

Tramadol DRUG

Tramadol 1 mg/kg IV given 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering

Also known as: Tramal, Ultram

Tramadol Group

Ketamine DRUG

Ketamine 0.5 mg/kg IV administered 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering.

Also known as: Ketalar, Ketaset

Ketamine Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Syed Muhammad Abbas: lead

Study Sites (2)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

Location

Syed Muhammad Abbas

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Interventions

Tramadol; Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Muhammad Q Abbas, MCPS, FCPS

  Sindh Institute of Urology and Transplantation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The study medications were prepared in identical syringes by an independent anesthesiologist not involved in patient care to maintain blinding. Both the anesthesia providers and outcome assessors were blinded to group allocation throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 29, 2025
• Study Start: June 29, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

PA (2)