Ephedrine Versus Ondansetron During Cesarean Delivery

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05127876

Collaborator

(none)

160

Enrollment

Location

Arms

7.1

Anticipated Duration (Months)

22.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death.

The effect of prophylactic ondansetron on blood pressure after spinal anesthesia has not been compared in a clinical trial with that of a vasoconstrictor. The investigators will compare ephedrine and ondansetron for the prevention of maternal hypotension after spinal anesthesia for elective cesarean delivery.

Condition or Disease	Intervention/Treatment	Phase
Spinal Induced Hypotension	Drug: Ondansetron 4 MG Drug: Ondansetron 8mg Drug: EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution Other: 10 mL normal saline	Phase 4

Detailed Description

Some vasopressive drugs including ephedrine and phenylephrine have been widely used to prevent maternal hypotension. Although ephedrine has mixed a-adrenoceptor activity , it maintains arterial pressure mainly by increases in cardiac output and heart rate as a result of its predominant activity on β1-adrenoceptors. It has been demonstrated that ondansetron preloading with crystalloid infusion reduces maternal hypotension in parturient women undergoing cesarean delivery.

Ondansetron has been widely used in the clinic to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron has been proven as a well-tolerated drug, but the most common side effects of ondansetron include headache, constipation, diarrhea, asthenia, and somnolence.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

According to patients' randomized groups, study medication was given over 1 min, 5 min before spinal anesthesia Patients were randomly assigned into 1 of 4 groups, using computer generated sequence and opaque envelopes, according to the prophylactic intravenous drug dose used: Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo.According to patients' randomized groups, study medication was given over 1 min, 5 min before spinal anesthesiaPatients were randomly assigned into 1 of 4 groups, using computer generated sequence and opaque envelopes, according to the prophylactic intravenous drug dose used:Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

This is a double-blind study at the level of patients, careproviders, and outcome assessors. Anesthesiologists, surgeons, and operating personnel did not know which study treatment was used. Syringes were identical in terms of volume, color, viscosity, and odor.

Primary Purpose:

Prevention

Official Title:

Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial

Actual Study Start Date :

Jan 10, 2022

Anticipated Primary Completion Date :

Jul 28, 2022

Anticipated Study Completion Date :

Aug 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group E Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered.	Drug: EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia Other Names: Ephedrine group
Experimental: Group OL Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered.	Drug: Ondansetron 4 MG Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia Other Names: Low dose ondansetron group
Experimental: Group OH Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered.	Drug: Ondansetron 8mg Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia Other Names: Higher dose Ondanseteron group
Placebo Comparator: Group P Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo. Then under aseptic precautions, spinal anesthesia was administered.	Other: 10 mL normal saline 10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia Other Names: Placebo group

Outcome Measures

Primary Outcome Measures

Incidence of Maternal hypotension [45 minutes]
Mean arterial blood pressure was recorded every 2 minute for 10 minutes then every 5 minutes until delivery. Time of intrathecal injection was considered as 0 min.

Secondary Outcome Measures

Apgar score [5 min after fetal delivery]
1and 5 min after fetal delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

age >18, <40 years;
American Society of Anesthesiologists physical status I or II;
term pregnancy
singleton pregnancy;
elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

Patients with a history of diabetes mellitus other than gestational diabetes,
hypertension,
body mass index >40 kg/m2,
complicated pregnancy, allergy to study drugs,
long QT syndrome,
Contraindication to spinal anesthesia
Patients who required general anesthesia were withdrawn from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Raham Hasan Mostafa, MD, Assistant Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05127876

Other Study ID Numbers:

R 04 2022

First Posted:

Nov 19, 2021

Last Update Posted:

Feb 7, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Raham Hasan Mostafa, MD, Assistant Professor, Ain Shams University

cesarean section

Bezold-Jarisch reflex

ondansetron

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 7, 2022