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

NCT07787702 — Not applicable, Not yet recruiting, 106 participants, Shaheed Mohtarma Benazir Bhutto Institue of Trauma

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

To Compare the Prophylactic Use of Low Doses of Intravenous Ketamine and Tramadol for the Prevention of Post Spinal Anaesthesia Shivering in Orthopedic Surgical Patients at Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT) Karachi, Sindh, Pakistan

Registry	NCT07787702
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	106 (Estimated)
Sponsor	Shaheed Mohtarma Benazir Bhutto Institue of Trauma (Other)
Conditions	Post-spinal Anesthesia Shivering
Interventions	Tramadol, Ketamin (Drug)
Dates	start 2026-08-21 (estimated), primary completion 2027-02-21 (estimated), completion 2027-02-21 (estimated), first posted 2026-08-26, last updated 2026-08-26
Locations	1 site in Pakistan

-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,

Expand all sections · Collapse all

+Detailed description

Post-spinal anesthesia shivering is a common and undesirable phenomenon in patients undergoing surgery under spinal anesthesia. This randomized controlled trial will compare the prophylactic use of low-dose intravenous ketamine and tramadol for prevention of post-spinal anesthesia shivering in orthopedic surgical patients. A total of 106 ASA I and II patients aged 18-60 years undergoing orthopedic surgery under spinal anesthesia will be randomly allocated into two groups. The tramadol group will receive intravenous tramadol 0.5 mg/kg and the ketamine group will receive intravenous ketamine 0.25 mg/kg immediately after spinal anesthesia. Patients will be monitored for shivering, body temperature, vital signs, pain, nausea, vomiting, alertness, adverse effects, and rescue medication requirements for 90 minutes. Shivering will be assessed using a graded scale from 0 to 4.

+Arms and interventions

Arm	Type	Interventions	Description
Tramadol Group	Active comparator	Drug: Tramadol	Participants in this group will receive intravenous tramadol 0.5 mg/kg immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.
Ketamine Group	Experimental	Drug: Ketamin	Participants in this group will receive intravenous ketamine 0.25 mg/kg immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

Tramadol (Drug): Intravenous tramadol 0.5 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.
Ketamin (Drug): Intravenous ketamine 0.25 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

+Outcome measures

Primary outcomes

Incidence of post-spinal anesthesia shivering [immediately after spinal anesthesia until 90 minutes post-spinal anesthesia]: Shivering will be assessed after spinal anesthesia and the occurrence of post-spinal anesthesia shivering will be recorded.

Secondary outcomes

Severity of post-spinal anesthesia shivering [immediately after spinal anesthesia until 90 minutes post-spinal anesthesia]: Severity of post-spinal anesthesia shivering will be assessed and recorded.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

* * ASA I and II patients aged 18-60 years.

  * Both genders.
  * Patients undergoing orthopedic surgery under spinal anesthesia.

Exclusion Criteria:

* * 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.

+Locations (1)

Facility	City	Country	Status
Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)	Karachi, Sindh	Pakistan

+Publications

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

+Investigators

Syed zafar Mehdi, Mbbs Fcps, Principal investigator, Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)