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Completed NCT07676955

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

Conditions: Cesarean Birth, Spinal Anesthesia, Sedation

Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 80
Sponsor: Haseki Training and Research Hospital

Location: Sultangazi Haseki Training and Research Hospital Istanbul Sultangazi

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.

Eligibility Criteria

Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical classification status I patients * aged \>18 years scheduled for cesarean/section surgery under spinal anesthesia were enrolled to the study Exclusion Criteria: * known sensitivity or allergy to study drugs * a history of analgesic or narcotic abuse * any contraindications for spinal anesthesia * emergency cesarean/section * existing of fetal distress.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07676955). StuddyBuddy aggregates publicly available trial information.