A Phase 1 interventional study of Ketalar and Ephedrine in Post Spinal Hypotension, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Ain Shams University · Phase 1, Interventional, and Other
Comparing ketamine and ephedrine to decrease the incidence of post spinal hypotension after caesarean section delivery.
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
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria:
0.5mg/kg ketamine
Drug: Ketalar
15 mg ephedrine
Drug: Ephedrine
women receiving sub-anesthetic dose of ketamine of 0.5 mg/kg IV bolus in 3 ml of normal saline.
Also known as: Ketamine
women receiving bolus of 15mg of ephedrine
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.
Time frame: From injection till the end of surgery
Plan to share: Yes — All data will be shared
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Ain Shams University