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Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07034911
Enrollment
100
Registered
2025-06-24
Start date
2024-04-01
Completion date
2024-09-15
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Spinal Hypotension

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

Interventions

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

DRUGEphedrine

women receiving bolus of 15mg of ephedrine

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hypotension post spinal in CSFrom injection till the end of surgeryFor 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026