Ondansetron for Postspinal Anesthesia Hypotension

NCT ID: NCT05475873

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-18

Study Completion Date

2023-10-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Adverse Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control group

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

Group Type SHAM_COMPARATOR

normal saline

Intervention Type DRUG

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

Ondansetron 4 mg

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

Group Type EXPERIMENTAL

Ondansetron 4 mg

Intervention Type DRUG

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

Ondansetron 8 mg

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

Group Type EXPERIMENTAL

Ondansetron 8 mg

Intervention Type DRUG

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

Interventions

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normal saline

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

Intervention Type DRUG

Ondansetron 4 mg

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

Intervention Type DRUG

Ondansetron 8 mg

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

Intervention Type DRUG

Other Intervention Names

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NS 5-HT3 receptor antagonist 5-HT3 receptor antagonist

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi Chen, M.D.

Role: STUDY_CHAIR

General Hospital of Ningxia Medical University

Locations

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General Hospital of Ningxia Medical University

Yinchuan, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40248081 (View on PubMed)

Other Identifiers

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Yi Chen-2022-1

Identifier Type: -

Identifier Source: org_study_id

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