drugset / Trial / NCT07676955

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

NCT07676955 ↗

Phase 4 Completed 80 enrolled Haseki Training and Research Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-06-01
Primary completion
2021-12-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.5 ug/kg Intravenous
Comparator Ketamine Small molecule 0.15 mg/kg Intravenous

Indications

No indication recorded.