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This randomized controlled trial assessed whether intravenous ondansetron is more effective than low dose ketamine in preventing shivering after spinal anesthesia in adults undergoing elective surgery. Post spinal shivering is a frequent and uncomfortable complication of spinal anesthesia and may increase oxygen demand and interfere with routine monitoring. Adults aged 20 to 70 years (body weight 50 to 80 kg; American Society of Anesthesiologists class I to II) scheduled for elective procedures under standardized spinal anesthesia were randomly allocated in equal numbers to receive either ondansetron 8 mg intravenously or ketamine 0.25 mg/kg intravenously, administered 5 minutes after the spinal injection. Perioperative temperature management was standardized for all participants. The primary outcome was the occurrence of post spinal shivering during intraoperative monitoring. Among 180 participants, shivering occurred in 30.0% of those receiving ondansetron and 44.4% of those receiving ketamine, showing a statistically significant reduction with ondansetron.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Ondansetron | Experimental | Received 8 mg of ondansetron administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering. |
|
| Group Low Dose Ketamine | Active Comparator | Received ketamine 0.25 mg per kilogram administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ondansetron | Drug | 8 mg ondansetron administered intravenously as a single dose five minutes after spinal anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Post Spinal Shivering | Occurrence of post spinal shivering following administration of study medication, assessed clinically by the anesthesiology team and recorded as present or absent during intraoperative monitoring after spinal anesthesia. | From 5 minutes after administration of study drug until transfer of the patient to the post-anesthesia care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeel Ahmed | Mayo Hospital Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Hospital, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D007649 | Ketamine |
| C000712971 | N-methyl-d-aspartate receptor antagonist MN-08 |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketamine (0.25 mg/kg) | Drug | 0.25 mg per kilogram ketamine administered intravenously as a single dose five minutes after spinal anesthesia. |
|
|
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |