Prevention of Spinal Induced Shivering During CS

Phase 2

Completed

• Conditions: Spinal Induced Shivering
• Interventions: Drug: Granisetron; Drug: Sodium chloride

• Registration Number: NCT02588547
• Lead Sponsor: Assiut University

Brief Summary

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

The study will includes four groups as follows:

1. Granisetron1 group: women will receive 1mg IV granisetron

2. Granisetron 0.7 group: women will receive 0.7 mg IV granisetron and

3. 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.

Study Timeline

• Study First Submitted: 2015-10-24
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2015-11
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Granisetron 0.7	Granisetron	Intravenous granisetron 0.7 mg
Granisetron 1	Granisetron	Intravenous granisetron 1 mg
Placebo	Sodium chloride	intravenous 0.9% Sodium chloride (2 ml)

Primary Outcome Measures

Name	Time	Method
shivering score	180 min (immediately before the block till 180 min after the block)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Seham Mohamed Moeen Ibrahim; 🇪🇬 Asyut, Egypt