Prevention of Spinal Induced Shivering During CS

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will includes four groups as follows: Granisetron1 group: women will receive 1mg IV granisetron Granisetron 0.7 group: women will receive 0.7 mg IV granisetron and Control group: women will receive 2 ml of 0.9% sodium chloride. Throughout the study period,shivering scores, core temperature, sensory level and motor block will be recorded, heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined. If heart rate decreases by more than 20% of the baseline atropin will be received and if blood pressure decreases 20% of the baseline ephedrine will be received. 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.

Official Title
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Prophylactic Granisetron for the Prevention of Spinal Induced Shivering During Cesarean Section: a Prospective Double Blind Dose Ranging Clinical Study

Conditions
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Spinal Induced Shivering

Intervention / Treatment
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* Drug: Granisetron
* Drug: Granisetron
* Drug: Sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women at term, ASA status I or II (American Society of Anesthesiologists) physical status class I-II, low-risk cesarean section, Scheduled for the spinal anesthesia Exclusion Criteria: Pregnant women in labor Patients who have the body temperature over 37.3 or less than 37 celsius degree Known allergies to the study drugs Contraindication to spinal anesthesia

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Granisetron 1<br>Intravenous granisetron 1 mg | Drug: Granisetron<br>* IV granisetron 1 mg before spinal anethesia<br>* Other names: Kytril ampule 3mg/3ml IV (Roche);|
| Active Comparator: Granisetron 0.7<br>Intravenous granisetron 0.7 mg | Drug: Granisetron<br>* IV granisetron 0.7 mg before spinal anethesia<br>* Other names: Kytril ampule 3mg/3ml IV (Roche);|
| Placebo Comparator: Placebo<br>intravenous 0.9% Sodium chloride (2 ml) | Drug: Sodium chloride<br>* IV 2 ml 0.9 sodium chloride before spinal anethesia<br>* Other names: 0.9 Sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shivering score |  | 180 min (immediately before the block till 180 min after the block) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| core temperature |  | 90 min (immediately before the block till 90 min after the block) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shivering, Granisetron, Spinal, Cesarean section