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Adverse EffectNCT05475873

Ondansetron for Postspinal Anesthesia Hypotension

A study testing normal saline, Ondansetron 4 mg and Ondansetron 8 mg in people with Adverse Effect, run by General Hospital of Ningxia Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Adverse Effect
What is being tested?
normal saline, Ondansetron 4 mg and Ondansetron 8 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
18 Jun 2023to 27 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Adverse Effect
Being tested
normal saline, Ondansetron 4 mg, Ondansetron 8 mg
Keywords
Ondansetron, Coload, Hypotension, Cesarean section
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • normal salineDrug

    Also called NS

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

  • Ondansetron 4 mgDrug

    Also called 5-HT3 receptor antagonist

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

  • Ondansetron 8 mgDrug

    Also called 5-HT3 receptor antagonist

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

Study groups in NCT05475873
Study groupRoleWhat they receive
Control groupSham comparatorA bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.
Receives: Drug: normal saline
Ondansetron 4 mgExperimentalA bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.
Receives: Drug: Ondansetron 4 mg
Ondansetron 8 mgExperimentalA bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.
Receives: Drug: Ondansetron 8 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall stability of systolic blood pressure control versus baseline

    Evaluated by performance error (PE)

    Measured: 1-15 minutes after spinal anesthesia

  2. The incidence of post-spinal anesthesia hypotension

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

    Measured: 1-15 minutes after spinal anesthesia

Secondary outcomes (10)

  1. Overall stability of heart rate control versus baseline

    Evaluated by performance error (PE).

    Measured: 1-15 minutes after spinal anesthesia

  2. The incidence of severe post-spinal anesthesia hypotension

    Systolic blood pressure (SBP) < 60% of the baseline

    Measured: 1-15 minutes after spinal anesthesia

  3. The incidence of nausea and vomiting.

    Presence of nausea and vomiting in patients after spinal anesthesia

    Measured: 1-15 minutes after spinal anesthesia

  4. The incidence of bradycardia.

    Heart rate < 55 beats/min.

    Measured: 1-15 minutes after spinal anesthesia

  5. The incidence of hypertension

    Systolic blood pressure (SBP) >120% of the baseline.

    Measured: 1-15 minutes after spinal anesthesia

  6. pH

    From umbilical arterial blood gases.

    Measured: Immediately after delivery

  7. Partial pressure of oxygen

    From umbilical arterial blood gases.

    Measured: Immediately after delivery

  8. Base excess

    From umbilical arterial blood gases.

    Measured: Immediately after delivery

  9. APGAR score

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Measured: 1 min after delivery

  10. APGAR score

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Measured: 5 min after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2022
  2. Study start18 Jun 2023
  3. Primary completion27 Oct 2023
  4. Study completion27 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475873
Sponsor's protocol ID
Yi Chen-2022-1
Status last verified
Jun 2023
First submitted
25 Jul 2022
Last updated
2 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40248081

Questions about this trial

What is this clinical trial studying?

A study testing normal saline, Ondansetron 4 mg and Ondansetron 8 mg in people with Adverse Effect, run by General Hospital of Ningxia Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall stability of systolic blood pressure control versus baseline (time frame: 1-15 minutes after spinal anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05475873, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.

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