Skip to main content
OpenTrials
Completed

NCT Number: NCT07034911

Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Spinal Hypotension

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Ainshams University

Cairo, 11111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketalar

Drug

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

Other names: Ketamine

Ephedrine

Drug

women receiving bolus of 15mg of ephedrine

Primary outcomes

  1. Incidence of hypotension post spinal in CS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Impact of Sub-anaesthetic Dose of Ketamine Versus Ephedrine on Post Spinal Hypotension in Caesarean Delivery

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.