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This study compares the efficacy of two different doses of intravenous (IV) granisetron on the prevention of postspinal shivering during cesarean section, in comparison with placebo.
The study will includes four groups as follows:
Also, Apgar score at one minute and five minutes will be recorded. At the end patient satisfaction will be assessed using Verbal Numeric Scoring system Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting, pruritus etc ) will be recorded perioperatively in the operating room and postanesthetic care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granisetron 1 | Active Comparator | Intravenous granisetron 1 mg |
|
| Granisetron 0.7 | Active Comparator | Intravenous granisetron 0.7 mg |
|
| Placebo | Placebo Comparator | intravenous 0.9% Sodium chloride (2 ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granisetron | Drug | IV granisetron 1 mg before spinal anethesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| shivering score | 180 min (immediately before the block till 180 min after the block) |
| Measure | Description | Time Frame |
|---|---|---|
| non invasive blood pressure | 90 min (immediately before the block till 90 min after the block) | |
| heart rate | 90 min (immediately before the block till 90 min after the block) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seham M Moeen, MD | Assiut Univerisity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seham Mohamed Moeen Ibrahim | Asyut | 71111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29424008 | Derived | Abdel-Ghaffar HS, Moeen SM. Prophylactic granisetron for post-spinal anesthesia shivering in cesarean section: A randomized controlled clinical study. Acta Anaesthesiol Scand. 2019 Mar;63(3):381-388. doi: 10.1111/aas.13084. Epub 2018 Feb 8. |
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| ID | Term |
|---|---|
| D017829 | Granisetron |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
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| Granisetron | Drug | IV granisetron 0.7 mg before spinal anethesia |
|
|
| Sodium chloride | Drug | IV 2 ml 0.9 sodium chloride before spinal anethesia |
|
|
| core temperature |
| 90 min (immediately before the block till 90 min after the block) |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |