Ephedrine Versus Ondansetron During Cesarean Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2022-03-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Induced Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution

Intervention Type DRUG

Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia

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.

Group Type EXPERIMENTAL

Ondansetron 4 MG

Intervention Type DRUG

Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia

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.

Group Type EXPERIMENTAL

Ondansetron 8mg

Intervention Type DRUG

Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia

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.

Group Type PLACEBO_COMPARATOR

10 mL normal saline

Intervention Type OTHER

10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia

Interventions

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Ondansetron 4 MG

Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia

Intervention Type DRUG

Ondansetron 8mg

Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia

Intervention Type DRUG

EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution

Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia

Intervention Type DRUG

10 mL normal saline

10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia

Intervention Type OTHER

Other Intervention Names

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Low dose ondansetron group Higher dose Ondanseteron group Ephedrine group Placebo group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No