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Ondansetron for Postspinal Anesthesia Hypotension

Primary Purpose

Adverse Effect

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
normal saline
Ondansetron 4 mg
Ondansetron 8 mg
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adverse Effect focused on measuring Ondansetron, Coload, Hypotension, Cesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Ningxia Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Control group

Ondansetron 4 mg

Ondansetron 8 mg

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Overall stability of systolic blood pressure control versus baseline
Evaluated by performance error (PE)
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline

Secondary Outcome Measures

Overall stability of heart rate control versus baseline
Evaluated by performance error (PE).
The incidence of severe post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 60% of the baseline
The incidence of nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of bradycardia.
Heart rate < 55 beats/min.
The incidence of hypertension
Systolic blood pressure (SBP) >120% of the baseline.
pH
From umbilical arterial blood gases.
Partial pressure of oxygen
From umbilical arterial blood gases.
Base excess
From umbilical arterial blood gases.
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Full Information

First Posted
July 25, 2022
Last Updated
June 18, 2023
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05475873
Brief Title
Ondansetron for Postspinal Anesthesia Hypotension
Official Title
Ondansetron for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect
Keywords
Ondansetron, Coload, Hypotension, Cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.
Arm Title
Ondansetron 4 mg
Arm Type
Experimental
Arm Description
A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.
Arm Title
Ondansetron 8 mg
Arm Type
Experimental
Arm Description
A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
NS
Intervention Description
A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.
Intervention Type
Drug
Intervention Name(s)
Ondansetron 4 mg
Other Intervention Name(s)
5-HT3 receptor antagonist
Intervention Description
A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.
Intervention Type
Drug
Intervention Name(s)
Ondansetron 8 mg
Other Intervention Name(s)
5-HT3 receptor antagonist
Intervention Description
A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.
Primary Outcome Measure Information:
Title
Overall stability of systolic blood pressure control versus baseline
Description
Evaluated by performance error (PE)
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of post-spinal anesthesia hypotension
Description
Systolic blood pressure (SBP) < 80% of the baseline
Time Frame
1-15 minutes after spinal anesthesia
Secondary Outcome Measure Information:
Title
Overall stability of heart rate control versus baseline
Description
Evaluated by performance error (PE).
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of severe post-spinal anesthesia hypotension
Description
Systolic blood pressure (SBP) < 60% of the baseline
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of nausea and vomiting.
Description
Presence of nausea and vomiting in patients after spinal anesthesia
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of bradycardia.
Description
Heart rate < 55 beats/min.
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of hypertension
Description
Systolic blood pressure (SBP) >120% of the baseline.
Time Frame
1-15 minutes after spinal anesthesia
Title
pH
Description
From umbilical arterial blood gases.
Time Frame
Immediately after delivery
Title
Partial pressure of oxygen
Description
From umbilical arterial blood gases.
Time Frame
Immediately after delivery
Title
Base excess
Description
From umbilical arterial blood gases.
Time Frame
Immediately after delivery
Title
APGAR score
Description
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time Frame
1 min after delivery
Title
APGAR score
Description
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time Frame
5 min after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Chen, M.D.
Phone
86-951-674-3252
Email
czzyxgp@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Chen, M.D.
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Chen, MD
Email
czzyxgp@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Ondansetron for Postspinal Anesthesia Hypotension

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