Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery

March 3, 2024 updated by: Ebtehal Ahmed Abdellattif, Sohag University

Comparison Between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks During Caesarean Delivery With Spinal Anesthesia: Randomized Clinical Trial

Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.

Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed M Abd-Elmaboud, assistant professor
  • Phone Number: 01150217744

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 21-40 years old.
  • Physical status American Society of Anesthesiologists (ASA)I&II.
  • Body mass index (BMI) < 35&>20 kg/m2.
  • Elective uncomplicated cesarean section under spinal anesthesia.

Exclusion Criteria:

  • Patient refusal.
  • Patients with known history of allergy to study drugs.
  • Advanced hepatic, renal and respiratory diseases.
  • Psychological and mental disorders.
  • Patient with reduced level of consciousness.
  • Hypertensive, cardiac, and diabetic patients.
  • Patients receiving anticoagulants therapy or suspected coagulopathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propofol
30 Patients will receive propofol as equal volumes of both 1% of propofol 10mg/ml and0.9% normal saline will be drawn in a 20-ml syringe before spinal puncture.
Drug: Propofol
Ondansetron
Other Names:
  • Pregabalin
Active Comparator: pregabalin
30 Patients will receive three capsules of pregabalin 100 mg once one hour before the surgical incision.
Drug: Propofol
Ondansetron
Other Names:
  • Pregabalin
Active Comparator: ondansetron
30 Patients will receive 4 mg ondansetron in 10 ml saline intravenously 5 min before spinal puncture.
Drug: Propofol
Ondansetron
Other Names:
  • Pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of nausea and vomiting with spinal anesthesia
Time Frame: 5 months
To compare between Propofol, Ondansetron and Pregabalin for control of emetic attacks during caesarean delivery with spinal anesthesia.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of hemodynamics postoperative
Time Frame: 5 months
Measurement of hemodynamics postoperative and Incidence of other side effects as :hypotension measured by non invasive blood pressure monitoring
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 18, 2024

Study Completion (Estimated)

August 18, 2024

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-12-02MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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