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Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Shivering is known to be a frequent complication, reported in 40 to 70% of patients undergoing surgery under regional anaesthesia. Shivering is a potentially serious complication, resulting in increased metabolic rate; increased oxygen consumption (up to 100-600%) along with raised carbon dioxide (CO2) production; ventilation and cardiac output; adverse postoperative outcomes.Post cesarean section spinal shivering is frequent. It causes involuntary muscular contractions and pain. Shivering, or muscular contractions, may be moderate or severe and persist for varying lengths. Anesthesia and body temperature fluctuations may produce post-spinal shivering. Properly managing post-spinal shivering improves patient outcomes and satisfaction.
Granisetron and pethidine treat post-spinal shivering. Granisetron blocks acetylcholine, a neurotransmitter that contracts muscles. Pethidine inhibits norepinephrine. Both drugs reduce post spinal shivering. However, the efficacy of granisetron and pethidine in treating post-cesarean spinal shivering has not been adequately explored.
Patients will undergo spinal anesthesia via the administration of 2.5ml of Bupivacaine 0.5% intrathecally using a 25-gauge spinal needle. The patients will be continuously monitored for any episodes of shivering, nausea, and vomiting. Vital data of the patients will also be closely monitored including oxygen saturation, pulse rate, blood pressure, respiratory rate and temperature at 10 minutes intervals throughout the operation and the stay in the recovery room. (PACU time around 30 minutes)
If shivering occurs the degree of Shivering will be classified as:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| granisetron group | Active Comparator | will receive granisetron 3 mg iv bolus |
|
| pethidine group | Active Comparator | will receive pethidine 25 mg iv bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granisetron 1 Mg/mL Intravenous Solution | Drug | will receive granisetron 3 mg iv bolus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| treating post spinal shivering | If shivering occurs the degree of Shivering will be classified as:
assessment of tested drugs in treating post spinal shivering in patients who undergone cesarean delivery and have been treated with either granisetron or pethidine | perioperatively/periprocedurally |
| Measure | Description | Time Frame |
|---|---|---|
| pain assessment | pain scores by VAS (visual analogue scale) which is from 0-10 , 0 no Pain and 10 worst pain | 12 hours postoperative |
| nausea, vomiting | incidence of postoperative complications: nausea, vomiting |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ayman M Kamaly, MD | Ain Shams University | Study Chair |
| David S Said, Msc | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D017829 | Granisetron |
| D008614 | Meperidine |
| ID | Term |
|---|---|
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
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| Pethidin |
| Drug |
will receive pethidine 25 mg iv bolus |
|
| 12 hours postoperative |
| D011720 |
| Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D010880 | Piperidines |