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| ID | Type | Description | Link |
|---|---|---|---|
| SIUT-ERC-2021/A-326 | Other Identifier | Sindh Institute of Urology and Transplantation, Pakistan |
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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:
Researchers will compare the tramadol group to the ketamine group to see which drug is more effective and safer for shivering prevention.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | Tramadol 1 mg/kg IV given 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Up to 60 minutes post spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 60 minutes post spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Analgesic Use | Administration of rescue pethidine (0.35 mg/kg IV) for Grade 3 shivering lasting more than 15 minutes will be recorded. | Within 60 minutes post spinal anesthesia |
| Adverse Events Monitoring |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Q Abbas, MCPS, FCPS | Sindh Institute of Urology and Transplantation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sindh Institute of Urology and Transplantation | Karachi | Sindh | 74200 | Pakistan | ||
| Syed Muhammad Abbas |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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The study medications were prepared in identical syringes by an independent anesthesiologist not involved in patient care to maintain blinding. Both the anesthesia providers and outcome assessors were blinded to group allocation throughout the study.
| Ketamine | Drug | Ketamine 0.5 mg/kg IV administered 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering. |
|
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| 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. |
| Up to 60 minutes post spinal anesthesia |
Incidence of other side effects including hypotension, hypertension, hallucinations, and excessive sedation will be actively monitored and recorded intraoperatively and up to 60 minutes after spinal anesthesia.
| Intraoperative and up to 60 minutes post spinal anesthesia |
| Karachi |
| Sindh |
| 74200 |
| Pakistan |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |