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COMPLETED
NCT07676955
PHASE4

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

Sponsor: Haseki Training and Research Hospital

View on ClinicalTrials.gov

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.

Official title: Dexmedetomidine Versus Ketamine Loading for Dexmedetomidine Sedation During Elective Cesarean Section Under Spinal Anesthesia: A Prospective Randomized Double-Blind Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2021-06-01

Completion Date

2021-12-31

Last Updated

2026-06-30

Healthy Volunteers

Yes

Interventions

DRUG

Dexmedetomidine

Maintenance sedation was achieved with dexmedetomidine infusion at 0.5 μg/kg/h after dexmedetomidine loading.

DRUG

Ketamine

Patients received intravenous ketamine 0.15 mg/kg over 10 minutes

Locations (1)

Sultangazi Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)