Clinical Trial

Dexmedetomidine Versus Ketamine Loading for Dexmedetomidine Sedation During Elective Cesarean Section Under Spinal Anesthesia

Study acronym: Sedation
Completed Phase 4
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Summary
This is a prospective, randomized, double-blind clinical study designed to compare the maternal and early neonatal effects of a loading dose of dexmedetomidine versus low-dose ketamine in parturients undergoing elective cesarean delivery under spinal anesthesia. Participants will be randomly assigned to receive either an intravenous loading dose of dexmedetomidine (1 μg/kg) or intravenous ketamine (0.15 mg/kg) immediately after the establishment of spinal anesthesia. In both groups, sedation will be maintained with a continuous dexmedetomidine infusion at a rate of 0.5 μg/kg/h. The primary and secondary outcomes include maternal hemodynamic parameters, sedation levels, patient and surgeon satisfaction scores, neonatal Apgar scores, and perioperative adverse events.
Trial Details
NCT Number NCT07676955
Lead Sponsor Haseki Training and Research Hospital
Conditions Cesarean Birth, Spinal Anesthesia, Sedation
Enrollment 80 participants
Start Date 2021-06-01
Primary Completion 2021-12-31 (estimated)
Study Completion 2021-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-30