Ondansetron for Postspinal Anesthesia Hypotension

Not Applicable

Completed

• Conditions: Adverse Effect
• Interventions: Drug: Ondansetron 4 mg; Drug: Ondansetron 8 mg; Drug: normal saline

• Registration Number: NCT05475873
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.

Detailed Description

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Ondansetron have been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, whether ondansetron could further reduction the incidence of post-spinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Status Verified: 2023-06
• Study Start: 2023-06-18
• Primary Completion: 2023-10-27
• Study Completion: 2023-10-27
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• 18-40 years
• Primipara or multipara
• Singleton pregnancy ≥ 37 weeks
• American Society of Anesthesiologists physical status classification I to II
• Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria

• Body height < 150 cm
• Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
• Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
• Hemoglobin < 7g/dl
• Fetal distress, or known fetal developmental anomaly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetron 4 mg	Ondansetron 4 mg	A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.
Ondansetron 8 mg	Ondansetron 8 mg	A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.
Control group	normal saline	A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
Overall stability of systolic blood pressure control versus baseline	1-15 minutes after spinal anesthesia	Evaluated by performance error (PE)
The incidence of post-spinal anesthesia hypotension	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \< 80% of the baseline

Secondary Outcome Measures

Name	Time	Method
Base excess	Immediately after delivery	From umbilical arterial blood gases.
Partial pressure of oxygen	Immediately after delivery	From umbilical arterial blood gases.
Overall stability of heart rate control versus baseline	1-15 minutes after spinal anesthesia	Evaluated by performance error (PE).
The incidence of nausea and vomiting.	1-15 minutes after spinal anesthesia	Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of hypertension	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \>120% of the baseline.
The incidence of severe post-spinal anesthesia hypotension	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \< 60% of the baseline
pH	Immediately after delivery	From umbilical arterial blood gases.
APGAR score	5 min after delivery	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
The incidence of bradycardia.	1-15 minutes after spinal anesthesia	Heart rate \< 55 beats/min.

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, China