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Ondansetron Combined With 6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05475873
Collaborator
(none)
150
Enrollment
3
Arms
9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effectiveness of ondansetron combined with 6% Hydroxyethyl starch (130/0.4) coload for postspinal anesthesia hypotension in patients undergoing cesarean section.

Condition or Disease Intervention/Treatment Phase
  • Drug: normal saline
  • Drug: Ondansetron 4 mg
  • Drug: Ondansetron 8 mg
 N/A

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. Colloid fluid coload and 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 combined with 6% Hydroxyethyl starch (130/0.4) coload for postspinal anesthesia hypotension in patients undergoing cesarean section.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Ondansetron Combined With 6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled Trial
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Control group

A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia. Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given.

Drug: normal saline
A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia. Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given.
Other Names:
  • NS

    		•
    Experimental: Ondansetron 4 mg

    A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia. Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given.

    Drug: Ondansetron 4 mg
    A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia. Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given.
    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. Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given.

    Drug: Ondansetron 8 mg
    A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia. Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given.
    Other Names:
  • 5-HT3 receptor antagonist

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall stability of systolic blood pressure control versus baseline [1-15 minutes after spinal anesthesia]

      Evaluated by performance error (PE)

    2. The incidence of post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia]

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

    Secondary Outcome Measures

    1. Overall stability of heart rate control versus baseline [1-15 minutes after spinal anesthesia]

      Evaluated by performance error (PE).

    2. The incidence of severe post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia]

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

    3. The incidence of nausea and vomiting. [1-15 minutes after spinal anesthesia]

      Presence of nausea and vomiting in patients after spinal anesthesia

    4. The incidence of bradycardia. [1-15 minutes after spinal anesthesia]

      Heart rate < 55 beats/min.

    5. The incidence of hypertension [1-15 minutes after spinal anesthesia]

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

    6. pH [Immediately after delivery]

      From umbilical arterial blood gases.

    7. Partial pressure of oxygen [Immediately after delivery]

      From umbilical arterial blood gases.

    8. Base excess [Immediately after delivery]

      From umbilical arterial blood gases.

    9. APGAR score [1 min after delivery]

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

    10. APGAR score [5 min after delivery]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    • Coagulation or renal function disorders

    • Known allergy to hydroxyethyl starch

    • Fetal distress, or known fetal developmental anomaly

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • General Hospital of Ningxia Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    General Hospital of Ningxia Medical University
    ClinicalTrials.gov Identifier:
    NCT05475873
    Other Study ID Numbers:
    • Yi Chen-2022-1
    First Posted:
    Jul 27, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by General Hospital of Ningxia Medical University
    Ondansetron
    Hydroxyethyl starch 130/0.4
    Coload
    Hypotension
    Cesarean section
    Additional relevant MeSH terms:
    Hypotension
    Ondansetron

    Study Results

    No Results Posted as of Jul 27, 2022