An interventional study of Tramadol and Ketamin in Post-spinal Anesthesia Shivering, sponsored by Shaheed Mohtarma Benazir Bhutto Institue of Trauma. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Shaheed Mohtarma Benazir Bhutto Institue of Trauma · Not applicable, Interventional, and Prevention
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,
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.
Shaheed Mohtarma Benazir Bhutto Institue of Trauma is the lead sponsor of 12 studies on the registry; 8 are open to participants now.
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* and II patients aged 18-60 years.
Exclusion Criteria:
* Patient refusal.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Intravenous tramadol 0.5 mg/kg will be administered 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.
Incidence of post-spinal anesthesia shivering
Shivering will be assessed after spinal anesthesia and the occurrence of post-spinal anesthesia shivering will be recorded.
Time frame: immediately after spinal anesthesia until 90 minutes post-spinal anesthesia
Severity of post-spinal anesthesia shivering
Severity of post-spinal anesthesia shivering will be assessed and recorded.
Time frame: immediately after spinal anesthesia until 90 minutes post-spinal anesthesia
Plan to share: No — 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.
Start is estimated for Aug 2026; primary completion for Feb 2027, 6 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Shaheed Mohtarma Benazir Bhutto Institue of Trauma