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