ShiveringPhase 3KETRA4PSASNCT07043049
Comparison of Prophylactic Use of Tramadol Versus Ketamine for Prevention of Post Spinal Anesthesia Shivering
A Phase 3 study testing Tramadol and Ketamine in people with Shivering, run by Syed Muhammad Abbas at 2 sites in Pakistan.
Trial summary
The goal of this clinical trial is to compare the effectiveness of tramadol versus ketamine in preventing shivering after spinal anesthesia in adult patients (ages 20-65) undergoing elective lower abdominal or inguinoscrotal surgeries. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shivering
- What is being tested?
- Tramadol and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesPakistan
- Study dates
- 29 Jun 2022to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 65 years,
- American Society of Anesthesiologists (ASA) Physical Status I or II, and
- Scheduled for elective lower abdominal or inguinoscrotal surgeries
- Under spinal anesthesia were included
Who cannot join
- Thyroid or neuromuscular disorders,
- Pregnant
- History of chronic sedative or narcotic use,
- Requiring intraoperative blood transfusion
- Had a baseline body temperature greater than 38°C or less than 36°C,
- Undergoing transurethral resection of the prostate (TURP).
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Sindh Institute of Urology and Transplantation
Karachi, Sindh, 74200
Syed Muhammad Abbas
Karachi, Sindh, 74200
About this study
The goal of this clinical trial is to compare the effectiveness of tramadol versus ketamine in preventing shivering after spinal anesthesia in adult patients (ages 20-65) undergoing elective lower abdominal or inguinoscrotal surgeries.
The main questions it aims to answer are:
Read more
- Does prophylactic intravenous tramadol reduce the incidence and severity of shivering more effectively than ketamine after spinal anesthesia?
- Are there differences in side effects, such as sedation or nausea, between tramadol and ketamine?
Researchers will compare the tramadol group to the ketamine group to see which drug is more effective and safer for shivering prevention.
Participants will:
- Be randomly assigned to receive either tramadol (1 mg/kg) or ketamine (0.5 mg/kg) five minutes after spinal anesthesia.
- Have their shivering severity assessed at 15, 30, 45, and 60 minutes using a standardized scale.
- Be monitored for sedation, nausea, and other possible side effects.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Also called Tramal, Ultram
Tramadol 1 mg/kg IV given 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering
KetamineDrug
Also called Ketalar, Ketaset
Ketamine 0.5 mg/kg IV administered 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol Group | Experimental | Patients in this group receive intravenous tramadol 1 mg/kg five minutes after the administration of spinal anesthesia. The intervention is administered in a double-blind manner using identical syringes prepared by an independent anesthesiologist. Receives: Drug: Tramadol |
| Ketamine Group | Active comparator | Patients in this group receive intravenous ketamine 0.5 mg/kg five minutes after spinal anesthesia, using identical administration procedures to maintain blinding. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Post-Spinal Anesthesia Shivering
The incidence and severity of shivering will be assessed using the Bedside Shivering Assessment Scale (BSAS) at 15, 30, 45, and 60 minutes following the administration of spinal anesthesia.
BSAS Grading:
- 0 = No shivering
- 1 = Piloerection or peripheral vasoconstriction without visible shivering
- 2 = Visible muscular activity confined to one muscle group
- 3 = Gross muscular activity involving the entire body
Measured: Up to 60 minutes post spinal anesthesia
Secondary outcomes (2)
Sedation Score
Sedation will be measured using the Ramsay Sedation Scale (RSS) at 15, 30, 45, and 60 minutes post spinal anesthesia.
RSS scores range from 1 (anxious, agitated) to 6 (no response). Median and interquartile ranges will be calculated for each group.
Measured: Up to 60 minutes post spinal anesthesia
Incidence of Postoperative Nausea and Vomiting (PONV)
PONV will be assessed using the PONV Impact Scale at 15, 30, 45, and 60 minutes post spinal anesthesia. Presence or absence will be recorded at each time point.
Measured: Up to 60 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 posted29 Jun 2025
- Study start29 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syed Muhammad Abbas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Syed Muhammad Abbas, Sindh Institute of Urology and Transplantation
- Investigators
- Muhammad Q Abbas, MCPS, FCPS, Study director, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043049
- Sponsor's protocol ID
- SIUT-ERC-2021/A-326
- Other IDs
- SIUT-ERC-2021/A-326
- Acronym
- KETRA4PSAS
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prophylactic Use of Tramadol Versus Ketamine for Prevention of Post Spinal Anesthesia Shivering
- ClinicalTrials.gov ID
- NCT07043049
- Acronym / sponsor ID
- KETRA4PSAS / SIUT-ERC-2021/A-326
- Conditions
- Shivering
- Keywords
- Shivering, Spinal Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Syed Muhammad AbbasUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Jun 2025 (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.
The goal of this clinical trial is to compare the effectiveness of tramadol versus ketamine in preventing shivering after spinal anesthesia in adult patients (ages 20-65) undergoing elective lower abdominal or inguinoscrotal surgeries.
The main questions it aims to answer are:
- Does prophylactic intravenous tramadol reduce the incidence and severity of shivering more effectively than ketamine after spinal anesthesia?
- Are there differences in side effects, such as sedation or nausea, between tramadol and ketamine?
Researchers will compare the tramadol group to the ketamine group to see which drug is more effective and safer for shivering prevention.
Participants will:
- Be randomly assigned to receive either tramadol (1 mg/kg) or ketamine (0.5 mg/kg) five minutes after spinal anesthesia.
- Have their shivering severity assessed at 15, 30, 45, and 60 minutes using a standardized scale.
- Be monitored for sedation, nausea, and other possible side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol Group | Experimental | Drug: TramadolPatients in this group receive intravenous tramadol 1 mg/kg five minutes after the administration of spinal anesthesia. The intervention is administered in a double-blind manner using identical syringes prepared by an independent anesthesiologist. |
| Ketamine Group | Active comparator | Drug: KetaminePatients in this group receive intravenous ketamine 0.5 mg/kg five minutes after spinal anesthesia, using identical administration procedures to maintain blinding. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 20 to 65 years,
- American Society of Anesthesiologists (ASA) Physical Status I or II, and
- Scheduled for elective lower abdominal or inguinoscrotal surgeries
- Under spinal anesthesia were included
Key exclusion criteria (6 listed)
- Thyroid or neuromuscular disorders,
- Pregnant
- History of chronic sedative or narcotic use,
- Requiring intraoperative blood transfusion
- Had a baseline body temperature greater than 38°C or less than 36°C,
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 |
|---|---|---|
| TramadolAlso: Tramal, UltramTramadol 1 mg/kg IV given 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering | Drug | Tramadol Group |
| KetamineAlso: Ketalar, KetasetKetamine 0.5 mg/kg IV administered 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering. | Drug | Ketamine Group |
Primary outcome
Incidence and Severity of Post-Spinal Anesthesia Shivering
Time frame: Up to 60 minutes post spinal anesthesia
The incidence and severity of shivering will be assessed using the Bedside Shivering Assessment Scale (BSAS) at 15, 30, 45, and 60 minutes following the administration of spinal anesthesia. BSAS Grading: * 0 = No shivering * 1 = Piloerection or peripheral vasoconstriction without visible shivering * 2 = Visible muscular activity confined to one muscle group * 3 = Gross muscular activity involving the entire body
2 secondary outcomes
Sedation Score
Time frame: Up to 60 minutes post spinal anesthesia
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Up to 60 minutes post spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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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. This study is not recruiting at the moment.
Muhammad Q Abbas, MCPS, FCPS study director
Sindh Institute of Urology and Transplantation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol and Ketamine in people with Shivering, run by Syed Muhammad Abbas at 2 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Post-Spinal Anesthesia Shivering (time frame: Up to 60 minutes post spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.