NCT05475873

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

June 18, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

November 2, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

July 25, 2022

Last Update Submit

October 31, 2023

Conditions

Adverse Effect

Keywords

OndansetronColoadHypotensionCesarean section

Outcome Measures

Primary Outcomes (2)

  • Overall stability of systolic blood pressure control versus baseline

    Evaluated by performance error (PE)

    1-15 minutes after spinal anesthesia

  • The incidence of post-spinal anesthesia hypotension

    Systolic blood pressure (SBP) \< 80% of the baseline

    1-15 minutes after spinal anesthesia

Secondary Outcomes (10)

  • Overall stability of heart rate control versus baseline

    1-15 minutes after spinal anesthesia

  • The incidence of severe post-spinal anesthesia hypotension

    1-15 minutes after spinal anesthesia

  • The incidence of nausea and vomiting.

    1-15 minutes after spinal anesthesia

  • The incidence of bradycardia.

    1-15 minutes after spinal anesthesia

  • The incidence of hypertension

    1-15 minutes after spinal anesthesia

  • +5 more secondary outcomes

Study Arms (3)

Control group

SHAM COMPARATOR

A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.

Drug: normal saline

Ondansetron 4 mg

EXPERIMENTAL

A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.

Drug: Ondansetron 4 mg

Ondansetron 8 mg

EXPERIMENTAL

A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.

Drug: Ondansetron 8 mg

Interventions

normal salineDRUG

A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.

Also known as: NS
Control group
Ondansetron 4 mgDRUG

A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.

Also known as: 5-HT3 receptor antagonist
Ondansetron 4 mg
Ondansetron 8 mgDRUG

A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.

Also known as: 5-HT3 receptor antagonist
Ondansetron 8 mg

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, 750004, China

Location

Related Publications (1)

  • Qin R, Xu X, Zhao N, Shi Y, Chen Y, Chen J, Ni X. Effect of different prophylactical doses of ondansetron for the hemodynamic stability in patients undergoing cesarean section: a randomized controlled study. Front Med (Lausanne). 2025 Apr 3;12:1495721. doi: 10.3389/fmed.2025.1495721. eCollection 2025.

    PMID: 40248081DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Saline SolutionOndansetronSerotonin 5-HT3 Receptor Antagonists

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingSerotonin AntagonistsSerotonin AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Yi Chen, M.D.

    General Hospital of Ningxia Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 27, 2022

Study Start

June 18, 2023

Primary Completion

October 27, 2023

Study Completion

October 27, 2023

Last Updated

November 2, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)