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Completed

NCT Number: NCT05475873

Ondansetron for Postspinal Anesthesia Hypotension

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

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Key information

Conditions

Adverse Effect Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, 750004, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

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

Other names: NS

Ondansetron 4 MG

Drug

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

Other names: 5-HT3 receptor antagonist

Ondansetron 8 mg

Drug

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

Other names: 5-HT3 receptor antagonist

Primary outcomes

  1. Overall stability of systolic blood pressure control versus baseline

    Time frame: 1-15 minutes after spinal anesthesia

    Evaluated by performance error (PE)

  2. The incidence of post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia

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

Secondary outcomes

  1. Overall stability of heart rate control versus baseline

    Time frame: 1-15 minutes after spinal anesthesia

    Evaluated by performance error (PE).

  2. The incidence of severe post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia

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

  3. The incidence of nausea and vomiting.

    Time frame: 1-15 minutes after spinal anesthesia

    Presence of nausea and vomiting in patients after spinal anesthesia

  4. The incidence of bradycardia.

    Time frame: 1-15 minutes after spinal anesthesia

    Heart rate < 55 beats/min.

  5. The incidence of hypertension

    Time frame: 1-15 minutes after spinal anesthesia

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

  6. pH

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  7. Partial pressure of oxygen

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  8. Base excess

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  9. APGAR score

    Time frame: 1 min after delivery

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

  10. APGAR score

    Time frame: 5 min after delivery

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

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2022
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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