MedTrace Logo

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

NCT07676955 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-06-30

No results posted yet for this study

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.

Conditions

  • Cesarean Birth
  • Spinal Anesthesia
  • Sedation

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

Sponsors & Collaborators

  • Haseki Training and Research Hospital

    lead OTHER

Principal Investigators

  • Halil C Canatan · Ozel Duygu Hastanesi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676955 on ClinicalTrials.gov