Ephedrine Versus Ondansetron During Cesarean Delivery

NCT05127876 | Completed Phase 4

• 1 other identifier: R 04 2022
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Induced Hypotension

Keywords

cesarean section; Bezold-Jarisch reflex; ondansetron

Outcome Measures

Primary Outcomes (1)

• Incidence of Maternal hypotension

  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.

  45 minutes

Secondary Outcomes (1)

• Apgar score

  5 min after fetal delivery

Study Arms (4)

Group E

EXPERIMENTAL

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

Group OL

EXPERIMENTAL

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

Group OH

EXPERIMENTAL

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

Group P

PLACEBO COMPARATOR

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

Interventions

Ondansetron 4 MG DRUG

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

Also known as: Low dose ondansetron group

Group OL

Ondansetron 8mg DRUG

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

Also known as: Higher dose Ondanseteron group

Group OH

EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution DRUG

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

Also known as: Ephedrine group

Group E

10 mL normal saline OTHER

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

Also known as: Placebo group

Group P

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Ondansetron; Ephedrine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: January 10, 2022
• Primary Completion: March 1, 2022
• Study Completion: March 6, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)