Post-spinal Anesthesia ShiveringNCT07787702
Comparison of Low-Dose Intravenous Ketamine and Tramadol for Prevention of Post-Spinal Anaesthesia Shivering in Orthopedic Surgical Patients
A study testing Tramadol and Ketamin in people with Post-spinal Anesthesia Shivering, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial 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, Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-spinal Anesthesia Shivering
- What is being tested?
- Tramadol and Ketamin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Aug 2026to 21 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- * ASA I and II patients aged 18-60 years.
- Both genders.
- Patients undergoing orthopedic surgery under spinal anesthesia.
Who cannot join
- * 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)
Karachi, Sindh, 74200
Aqsa Sattar, Mbbs Fcps ( pg), +92 342-2437774, aqsasattar920@gmail.com
Syed zafar Mehdi, Mbbs fcps
About this study
Official title: 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,
Read the 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.
- Conditions
- Post-spinal Anesthesia Shivering
- Being tested
- Tramadol, Ketamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Intravenous tramadol 0.5 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.
KetaminDrug
Intravenous ketamine 0.25 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ketamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-spinal anesthesia shivering
Shivering will be assessed after spinal anesthesia and the occurrence of post-spinal anesthesia shivering will be recorded.
Measured: immediately after spinal anesthesia until 90 minutes post-spinal anesthesia
Secondary outcomes (1)
Severity of post-spinal anesthesia shivering
Severity of post-spinal anesthesia shivering will be assessed and recorded.
Measured: immediately after spinal anesthesia until 90 minutes post-spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start21 Aug 2026 (estimated)
- Primary completion21 Feb 2027 (estimated)
- Study completion21 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-spinal Anesthesia ShiveringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial comparing prophylactic intravenous ketamine and tramadol for prevention of post-spinal anesthesia shivering.
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqsa Sattar, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Investigators
- Syed zafar Mehdi, Mbbs Fcps, Principal investigator, Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787702
- Sponsor's protocol ID
- IRB-000242/SMBBIT/Approval2026
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 23087460
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07787702
- Acronym / sponsor ID
- IRB-000242/SMBBIT/Approval2026
- Conditions
- Post-spinal Anesthesia Shivering
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 21 Aug 2026 (estimated)
- Primary completion
- 21 Feb 2027 (estimated)
- Study completion
- 21 Feb 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial comparing prophylactic intravenous ketamine and tramadol for prevention of post-spinal anesthesia shivering.
| Arm | Type | Receives |
|---|---|---|
| Tramadol Group | Active comparator | Drug: TramadolParticipants 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: KetaminParticipants in this group will receive intravenous ketamine 0.25 mg/kg immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- * ASA I and II patients aged 18-60 years.
Key exclusion criteria (4 listed)
- * Patient refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolIntravenous tramadol 0.5 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering. | Drug | Tramadol Group |
| KetaminIntravenous ketamine 0.25 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering. | Drug | Ketamine Group |
Primary outcome
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.
1 secondary outcome
Severity of post-spinal anesthesia shivering
Time frame: immediately after spinal anesthesia until 90 minutes post-spinal anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 23087460Wason 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.
- Individual participant dataSharing planned: 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.
Related trials for Post-spinal Anesthesia Shivering
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Syed zafar Mehdi, Mbbs Fcps principal investigator
Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tramadol and Ketamin in people with Post-spinal Anesthesia Shivering, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aqsa Sattar, Mbbs Fcps 2( pg) (+92 342-2437774, aqsasattar920@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-spinal anesthesia shivering (time frame: immediately after spinal anesthesia until 90 minutes post-spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07787702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.