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Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section

Primary Purpose

Hypotension, Nausea, Vomiting

Status
Completed
Phase
Phase 3
Locations
Jordan
Study Type
Interventional
Intervention
Ondansetron
Normal saline
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring Ondansetron, hypotension, nausea and vomiting, cesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • patients who received spinal anesthesia for elective cesarean sections and meet the American Society of Anesthesiologist's (ASA) patient status classification I or II.

Exclusion Criteria:

  • Patients ASA patient status classification III, IV or V
  • Emergent cesarean sections
  • Multiple parities (twins/triplets)
  • More than 1,000 ml blood loss
  • More than 6 mg ondansetron administered
  • Patients presenting with a cardiac history (coronary artery disease, myocardial infarction, congestive heart failure, murmur, mitral valve prolapse/regurgitation, dysrhythmias, aortic stenosis/regurgitation)
  • Patients presenting with preeclampsia
  • Patients presenting for cesarean section with epidural due to failure to progress.

Sites / Locations

  • Jordan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

group O4

group O6

group C

Arm Description

Patients received 4mg ondansetron.

Patients received 6mg ondansetron.

Patients received normal saline.

Outcomes

Primary Outcome Measures

Usage of Ondansetron prophylactically to prevent a significant decrease in systolic, diastolic, and mean blood pressure after the induction of spinal anaesthesia.
Baseline values of Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Blood Pressure (MBP) were recorded. Ondansetron was given 15 minutes before induction of spinal anesthesia. After initiation of spinal anesthesia, the SBP, DBP, and MBP were recorded regularly until the end of the cesarean section by a blinded anaesthesiologist.

Secondary Outcome Measures

Prevention of intraoperative nausea and vomiting.
Patients were assessed for nausea, and vomiting throughout the whole intraoperative period by asking and observing the patients for any signs and/or symptoms of nausea, and we recorded any incident of intraoperative vomiting using the following scale: 0) no any complaint. mild degree of nausea. moderate degree of nausea and vomit. frequently vomit. severely (continuously vomit.

Full Information

First Posted
October 13, 2019
Last Updated
October 23, 2019
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT04140058
Brief Title
Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section
Official Title
Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section, a Prospective, Randomized Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2016 (Actual)
Primary Completion Date
January 2, 2017 (Actual)
Study Completion Date
January 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

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

5. Study Description

Brief Summary
Spinal anaesthesia for caesarean section is the most commonly used anaesthetic choice in caesarean deliveries. This is usually associated with maternal hypotension and other adverse side effects. Prophylactic intravenous administration of ondansetron immediately and 5 minutes preoperatively have shown to provide a protective effect against hypotension while other studies have shown little effect on the incidence of blood pressure drop in healthy parturients. The investigators will study the effect of different doses and timing of intravenous ondansetron in full term obstetric patients undergoing elective lower segment caesarean section under spinal anaesthesia on the incidence and severity of hypotension and other adverse side effects in healthy parturients having the standard intrathecal plain bupivacaine and fentanyl.
Detailed Description
This prospective randomized double-blind placebo-controlled study will include 150 American Society of Anaesthesiologist physical status grade I (ASA I) pregnant women scheduled for elective caesarean delivery under spinal anaesthesia. Patients will be randomly allocated into three groups (n = 50) to receive intravenous ondansetron 4mg in 10 mL normal saline (group O4), 6 mg in 10 mL normal saline(group O6), or placebo of 10 mL normal saline (group C), all 15-20 minutes before spinal anaesthesia. Hemodynamic variables and other adverse effects will be assessed at 16 time points intraoperatively. Those variables include blood pressure, heart rate, oxygen saturation, nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus, perioperative vasopressor requirements and patients' satisfaction. Participants will be randomly allocated preoperatively as per randomizer.org software and will be blinded from other anaesthetists performing the spinal block and following patients intraoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Nausea, Vomiting
Keywords
Ondansetron, hypotension, nausea and vomiting, cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group O4
Arm Type
Active Comparator
Arm Description
Patients received 4mg ondansetron.
Arm Title
group O6
Arm Type
Active Comparator
Arm Description
Patients received 6mg ondansetron.
Arm Title
group C
Arm Type
Placebo Comparator
Arm Description
Patients received normal saline.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
ondansetron was administered 20 minutes prior to spinal anesthesia.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Placebo of 10 mL normal saline was administered.
Primary Outcome Measure Information:
Title
Usage of Ondansetron prophylactically to prevent a significant decrease in systolic, diastolic, and mean blood pressure after the induction of spinal anaesthesia.
Description
Baseline values of Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Blood Pressure (MBP) were recorded. Ondansetron was given 15 minutes before induction of spinal anesthesia. After initiation of spinal anesthesia, the SBP, DBP, and MBP were recorded regularly until the end of the cesarean section by a blinded anaesthesiologist.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Prevention of intraoperative nausea and vomiting.
Description
Patients were assessed for nausea, and vomiting throughout the whole intraoperative period by asking and observing the patients for any signs and/or symptoms of nausea, and we recorded any incident of intraoperative vomiting using the following scale: 0) no any complaint. mild degree of nausea. moderate degree of nausea and vomit. frequently vomit. severely (continuously vomit.
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
full-term pregnant females undergoing cesarean section.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients who received spinal anesthesia for elective cesarean sections and meet the American Society of Anesthesiologist's (ASA) patient status classification I or II. Exclusion Criteria: Patients ASA patient status classification III, IV or V Emergent cesarean sections Multiple parities (twins/triplets) More than 1,000 ml blood loss More than 6 mg ondansetron administered Patients presenting with a cardiac history (coronary artery disease, myocardial infarction, congestive heart failure, murmur, mitral valve prolapse/regurgitation, dysrhythmias, aortic stenosis/regurgitation) Patients presenting with preeclampsia Patients presenting for cesarean section with epidural due to failure to progress.
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No identifying information will be collected. Data will be used solely for statistical analysis.

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Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section

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