Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery

Phase 1

Completed

• Conditions: Post Spinal Hypotension
• Interventions: Drug: Ketalar; Drug: Ephedrine

• Registration Number: NCT07034911
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-04-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-15
• Study First Submitted: 2025-06-15
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing Caesarian Section under spinal anesthesia,
• Patients aged 18-45 years,
• At term (≥37-week gestation),
• American Society of Anaesthesiologists (ASA) physical status 1 or 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine group	Ketalar	0.5mg/kg ketamine
Ephedrine group	Ephedrine	15 mg ephedrine

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension post spinal in CS	From injection till the end of surgery	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.

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt