Effect of Prophylactic Ondansetron on the Incidence of Spinal-anesthesia-induced Shivering and Hypotension in Elective Cesarean Sections

Phase 3

Completed

• Conditions: cesarean section; spinal anesthesia induced hypotensionspinal anesthesia induced shiveringbradycardianauseavomitingheadachepainpruritusdizzinessrespiratory depression.; spinal anesthesia; hypotension; shivering

• Registration Number: TCTR20200825001
• Lead Sponsor: Ahmad Salahat (MSc )

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-10-10
• Study Start: 2020-08-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Patients undergoing elective cesarean sections surgery
2. American Society of Anesthesiologists (ASA) I or II classification
3. No major systemic diseases

Exclusion Criteria

1. Pre-existing or gestational hypertension
2. History of allergy to ondansetron drug
3. Cardiovascular or cerebrovascular diseases
4. Urgent cesarean sections
5. Mothers with suspected deteriorated fetuses
6. Contraindications for spinal block
7. Thyroid disorders
8. Participant temperature > 38°C or < 36.5°C
9. Patients likely to receive intraoperative blood transfusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence spinal-anesthesia-induced Hypotension induction time,3,9,12,15 minutes intraoperatively and 5,10,15 min postoperatively hypotension is defined as systolic blood pressure lower than 100 mmHg ,Incidence spinal-anesthesia-induced shivering induction time,3,9,12,15 minutes intraoperatively and 5,10,15 min postoperatively Shivering was graded using the previously validated 5-item scale (Crossley & Mahajan, 1994; Tsai & C

Secondary Outcome Measures

Name	Time	Method
perioperative bradycardia nausea,vomiting,headache,pain,pruritus,dizziness respiratory depression. induction time,3,9,12,15 minutes intraoperatively and 5,10,15 min postoperatively pain and headache measured using the numerical rating scale (0-10),Nausea and vomiting 0-5 scale