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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07787702

Enrollment

106

Registered

2026-08-26

Start date

2026-08-21

Completion date

2027-02-21

Last updated

2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-spinal Anesthesia Shivering

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,

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.

Interventions

DRUGTramadol

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

DRUGKetamin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Pakistan

Contacts

CONTACTAqsa Sattar, Mbbs Fcps 2( pg)

aqsasattar920@gmail.com+92 342-2437774

PRINCIPAL_INVESTIGATORSyed zafar Mehdi, Mbbs Fcps

Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026