Clinical trial

Effects of Low Dose ketamıne on Postpartum Depression During Caesarean Sections

Name

inonu Caesarean

Description

The results of ketamine, ketamine and midazolom and placebo can be copied after birth in cesareans subjected to spinal anesthesia.

Trial arms

Trial start

2024-06-01

Estimated PCD

2024-08-01

Trial end

2024-09-01

Status

Not yet recruiting

Treatment

Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia

A single dose of 0.5 mg/kg IV diluted to 5 ml with 0.9% saline was planned to be administered simultaneously to the Ketamine Group (GROUP 1), ketamine and midazolam within 5 minutes after the newborn umbilical cord was clamped (Group 2). After midazolam 0.03 mg/kg is given, a single dose IV bolus of 0.5 mg/kg diluted to 5 ml with 0.9% saline will be administered. Patients experience dizziness, hallucinations, nausea, headache, vomiting, diplopia and blurred vision, the time until the first analgesic request; Depression parameters will be evaluated with the Edinburgh Postpartum Depression Scale (EPDS) in all patients before cesarean section and at the 1st, 2nd and 4th weeks after birth.

Arms:

Group 2-ketamine + midazolam, Group 3-placebo, Grup 1 -Ketamine Group

Size

150

Primary endpoint

postpartum depression

4 weeks

intraoperative complications

1 day

postoperative pain

1 day

Eligibility criteria

Inclusion Criteria: American Society of Anesthesiologists 2-.3 18 -45years old Patients planned to be born by cesarean section The patient requests a cesarean section with spinal anesthesia ExclusionCriteria: Pathological obstetric complications Hypertension Contraindication for ketamine Contraindication for spinal

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '3 Months', 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

Updated at

2024-02-01

1 organization

1 product

2 indications

Organization

Inonu University

Product

Ketamine + Midazolam or Ketamine for Cesarean Section under Spinal Anesthesia

Indication

Postoperative Pain

Indication

Postpartum Depression