Dose Low Dose Ketamine in Casesarian

Postoperative Pain Clinical Trial

Official title:

Effects of Low Dose ketamıne on Postpartum Depression During Caesarean Sections

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06237569
• Other study ID #: inonu Caesarean
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Inonu University
• Contact: DUYGU DEMIROZ, dr
• Phone: +905319504421
• Email: drduygudemiroz[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

Postpartum depression will be evaluated by dividing the patients into 3 groups: group 1 as ketamine, group 2 as ketamine and midasom, and group 3 as placebo group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postoperative Pain
• Postpartum Depression

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Inonu universitesi	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postpartum depression	Reducing postpartum depression with low-dose ketamine	4 weeks
Primary	intraoperative complications	Reducing postpartum depression by reducing ketamine-related intraoperative complications	1 day
Primary	postoperative pain	Reducing postoperative pain with low dose ketamine	1 day