Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery

NCT ID: NCT07034911

Last Updated: 2025-06-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparing ketamine and ephedrine to decrease the incidence of post spinal hypotension after caesarean section delivery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To compare the effect of ketamine versus ephedrine in decreasing the incidence of hypotension in caesarean section delivery a study group including 50 participants will receive ketamine and 50 group will receive ephedrine after the consent and detailed history the two groups will receive preload of 500ml enter acetate then dormicum for sedation then spinal anesthesia will be performed initial blood pressure and heart rate will be measured then every five minutes

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Spinal Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketamine group

0.5mg/kg ketamine

Group Type ACTIVE_COMPARATOR

Ketalar

Intervention Type DRUG

women receiving sub-anesthetic dose of ketamine of 0.5 mg/kg IV bolus in 3 ml of normal saline.

Ephedrine group

15 mg ephedrine

Group Type ACTIVE_COMPARATOR

Ephedrine

Intervention Type DRUG

women receiving bolus of 15mg of ephedrine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketalar

women receiving sub-anesthetic dose of ketamine of 0.5 mg/kg IV bolus in 3 ml of normal saline.

Intervention Type DRUG

Ephedrine

women receiving bolus of 15mg of ephedrine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ketamine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing Caesarian Section under spinal anesthesia,
* Patients aged 18-45 years,
* At term (≥37-week gestation),

Exclusion Criteria

* Pre-eclampsia,
* Chronic hypertension, cardiovascular troubles,
* Any contraindication to regional anesthesia such as local infection or bleeding disorders,
* Any hypersensitivity to ketamine.
* Declined informed consent.
* American Society of Anaesthesiologists (ASA) physical status lll or lV
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Basant E Mohamed, M.B.B.CH

Role: PRINCIPAL_INVESTIGATOR

Anesthesia resident Alain Shams University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ainshams University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMASU MS130/2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ephedrine and Phenylephrine for Spinal Hypotension
NCT03047109 COMPLETED PHASE2/PHASE3