Comparison of Low-Dose Intravenous Ketamine and Tramadol for Prevention of Post-Spinal Anaesthesia Shivering in Orthopedic Surgical Patients

NCT07787702 | Not Yet Recruiting

• 1 other identifier: IRB-000242/SMBBIT/Approval2026
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will compare the prophylactic effectiveness of low-dose intravenous ketamine and tramadol in preventing post-spinal anesthesia shivering in patients undergoing orthopedic surgery at Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT), Karachi,

Conditions

Post-spinal Anesthesia Shivering

Outcome Measures

Primary Outcomes (1)

• Incidence of post-spinal anesthesia shivering

  Shivering will be assessed after spinal anesthesia and the occurrence of post-spinal anesthesia shivering will be recorded.

  immediately after spinal anesthesia until 90 minutes post-spinal anesthesia

Secondary Outcomes (1)

• Severity of post-spinal anesthesia shivering

  immediately after spinal anesthesia until 90 minutes post-spinal anesthesia

Study Arms (2)

Tramadol Group

ACTIVE COMPARATOR

Participants in this group will receive intravenous tramadol 0.5 mg/kg immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

Drug: Tramadol

Ketamine Group

EXPERIMENTAL

Participants in this group will receive intravenous ketamine 0.25 mg/kg immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

Drug: Ketamin

Interventions

Tramadol DRUG

Intravenous tramadol 0.5 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

Tramadol Group

Ketamin DRUG

Intravenous ketamine 0.25 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

Ketamine Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \* ASA I and II patients aged 18-60 years.
• Both genders.
• Patients undergoing orthopedic surgery under spinal anesthesia.

You may not qualify if:

• \* Patient refusal.
• ASA III and ASA IV.
• Prolonged surgical procedures expected to be more than 90 minutes.
• Patients who received blood transfusion or study drugs other than for the study purpose.

Sponsors & Collaborators

• Shaheed Mohtarma Benazir Bhutto Institue of Trauma: lead

Study Sites (1)

Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (1)

• Wason R, Jain N, Gupta P, Gogia AR. Randomized double-blind comparison of prophylactic ketamine, clonidine and tramadol for the control of shivering under neuraxial anaesthesia. Indian J Anaesth. 2012 Jul;56(4):370-5. doi: 10.4103/0019-5049.100821.

  PMID: 23087460 BACKGROUND

MeSH Terms

Interventions

Tramadol

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Syed zafar Mehdi, Mbbs Fcps

  Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aqsa Sattar, Mbbs Fcps 2( pg)

CONTACT

+92 342-2437774; aqsasattar920@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate traineee (Fcps ll candidate )

Model Details: Two-arm randomized controlled trial comparing prophylactic intravenous ketamine and tramadol for prevention of post-spinal anesthesia shivering.

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): February 21, 2027
• Study Completion (Estimated): February 21, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)