Trials Sponsors Conditions Drugs Pricing

Conditions

Post Spinal Hypotension

Outcome Measures

Primary Outcomes (1)

Incidence of hypotension post spinal in CS
For ketamine Group: women receiving sub-anesthetic dose of ketamine of 0.5 mg/kg IV bolus in 3 ml of normal saline. ( Reves JG et al,2010 ) * For ephedrine Group: women receiving bolus of 15mg of ephedrine * All the patients will receive 2 mg midazolam IV directly after delivery of the fetus.( Perumal DK et al ) * Heart Rate (HR) and Mean Arterial Blood Pressure (MAP) will be recorded at baseline 5 minutes prior to the intrathecal injection and 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection and then every 15 minutes till the end of the operation. * Incidence of hypotension will be recorded which is defined as MAP less than 20% below the baseline or was ≤ 65 mmHg. Incidence of severe hypotension ≤ 50 mmHg will be recorded.
From injection till the end of surgery

Study Arms (2)

Ketamine group

ACTIVE COMPARATOR

0.5mg/kg ketamine

Drug: Ketalar

Ephedrine group

ACTIVE COMPARATOR

15 mg ephedrine

Drug: Ephedrine

Interventions

KetalarDrug

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

Also known as: Ketamine

Ketamine group

EphedrineDrug

women receiving bolus of 15mg of ephedrine

Ephedrine group

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Patients undergoing Caesarian Section under spinal anesthesia,
Patients aged 18-45 years,

Sponsors & Collaborators

Ain Shams University
Otherlead

Study Sites (1)

Ainshams University

Cairo, 11111, Egypt

MeSH Terms

Interventions

KetamineEphedrine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesPhenethylaminesEthylamines

Study Officials

Basant E Mohamed, M.B.B.CH
Anesthesia resident Alain Shams University
PRINCIPAL INVESTIGATOR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 15, 2025

First Posted

June 24, 2025

Study Start

April 1, 2024

Actual (reported)

Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Ketamine group

Ephedrine group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Ketamine group

Ephedrine group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations