Ondansetron for Postspinal Anesthesia Hypotension

Ondansetron for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Adverse Effect
• Intervention / Treatment: Drug: normal saline; Drug: Ondansetron 4 mg; Drug: Ondansetron 8 mg

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yinchuan, China, 750004
    • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.	Drug: normal saline; A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.; Other Names: NS
Experimental: Ondansetron 4 mg; A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.	Drug: Ondansetron 4 mg; A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.; Other Names: 5-HT3 receptor antagonist
Experimental: Ondansetron 8 mg; A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.	Drug: Ondansetron 8 mg; A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.; Other Names: 5-HT3 receptor antagonist

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Study Chair: Yi Chen, M.D., General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hypotension; Cesarean section; Ondansetron; Coload
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Ondansetron
• Other Study ID Numbers: Yi Chen-2022-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No