A clinical trial to study the effectiveness of a drug Granisetron to prevent shivering, nausea and vomiting, which occurs after giving spinal anaesthesia in pregnant females undergoing cesarean sectio
Phase 4
Completed
- Conditions
- Health Condition 1: G978- Other intraoperative and postprocedural complications and disorders of nervous system
- Registration Number
- CTRI/2018/12/016756
- Lead Sponsor
- Maulana Azad Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Parturients scheduled for elective caesarean delivery under spinal anaesthesia
2. Aged 20-45 years
3. Full term singleton pregnancy
Exclusion Criteria
1. Parturient with contra-indications to regional anaesthesia
2. ASA Physical Status > II
3. Allergy to 5-HT3 Antagonists
4. Morbidly Obese
5. Placenta Previa
6. Use of vasodilators
7. Pre-operative body temperature >38 C or < 36.5 C
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Shivering ScoreTimepoint: 5 minutes before study drug administration till 180 minutes after spinal block
- Secondary Outcome Measures
Name Time Method 1. Incidence of nausea and/or vomiting <br/ ><br>2. Tympanic Membrane temperature <br/ ><br>3. Neonatal APGAR Score at 1 and 5 min <br/ ><br>4. Patient Satisfaction Score-24 hours after procedure <br/ ><br>5. Haemodynamic parameters ( heart rate, Systolic and diastolic blood pressure, mean arterial pressure, SpO2) <br/ ><br>6. Total dose of rescue drug required for shivering (pethidine) <br/ ><br>7. Total dose of rescue anti-emetic required for nausea and vomiting (metoclopramide)Timepoint: 5 minutes before study drug administration till 90 minutes after spinal block