Comparison of Low-Dose Intravenous Ketamine and Tramadol for Prevention of Post-Spinal Anaesthesia Shivering in Orthopedic Surgical Patients
August 22, 2026 updated by: Aqsa Sattar, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
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
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,
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aqsa Sattar, Mbbs Fcps 2( pg)
- Phone Number: +92 342-2437774
- Email: aqsasattar920@gmail.com
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74200
- Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)
-
Contact:
- Aqsa Sattar, Mbbs Fcps ( pg)
- Phone Number: +92 342-2437774
- Email: aqsasattar920@gmail.com
-
Principal Investigator:
- Syed zafar Mehdi, Mbbs fcps
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Tramadol Group
Participants in this group will receive intravenous tramadol 0.5 mg/kg immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.
|
Intravenous tramadol 0.5 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.
|
|
Experimental: Ketamine Group
Participants in this group will receive intravenous ketamine 0.25 mg/kg immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.
|
Intravenous ketamine 0.25 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of post-spinal anesthesia shivering
Time Frame: 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.
|
immediately after spinal anesthesia until 90 minutes post-spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of post-spinal anesthesia shivering
Time Frame: immediately after spinal anesthesia until 90 minutes post-spinal anesthesia
|
Severity of post-spinal anesthesia shivering will be assessed and recorded.
|
immediately after spinal anesthesia until 90 minutes post-spinal anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Syed zafar Mehdi, Mbbs Fcps, Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 21, 2026
Primary Completion (Estimated)
February 21, 2027
Study Completion (Estimated)
February 21, 2027
Study Registration Dates
First Submitted
August 22, 2026
First Submitted That Met QC Criteria
August 22, 2026
First Posted (Actual)
August 26, 2026
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 22, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-000242/SMBBIT/Approval2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared with other researchers.
Data will be used only for the purposes of this study and will be maintained confidentially in accordance with institutional and ethical requirements.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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