Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery

NCT07034911 | Completed Phase 1 DMC

• 1 other identifier: FMASU MS130/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Ketalar DRUG

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

Ephedrine DRUG

women receiving bolus of 15mg of ephedrine

Ephedrine group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, 11111, Egypt

Location

MeSH Terms

Interventions

Ketamine; Ephedrine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Basant E Mohamed, M.B.B.CH

  Anesthesia resident Alain Shams University

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: September 1, 2024
• Study Completion: September 15, 2024
• Last Updated: June 24, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before1/2026
• Access Criteria: Free

Locations

EG (1)