Dose Low Dose Ketamine in Casesarian

Effects of Low Dose ketamıne on Postpartum Depression During Caesarean Sections

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Postpartum Depression
• Intervention / Treatment: Drug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: DUYGU DEMIROZ, dr; Phone Number: +905319504421; Email: drduygudemiroz@hotmail.com
• Study Contact Backup: Name: OSMAN TOPLU, dr; Phone Number: 905321137771; Email: osman.toplu@inonu.edu.tr

Study Locations

• Turkey
  • Malatya, Turkey, 44050
    • Inonu universitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients undergoing cesarean section under spinal anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Grup 1 -Ketamine Group; Ketamine Group (GROUP 1) 0.5 mg/kg IV single dose bolus diluted to 5 ml with 0.9% saline	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.
Group 2-ketamine + midazolam; Midazolam 0.0125 mg/kg is given followed by a single IV bolus dose of 0.5 mg/kg diluted to 5 ml with 0.9% saline.	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.
Group 3-placebo; Group 3-placebo ;A single dose of IV 5 ml physiological saline will be given.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postpartum depression	Reducing postpartum depression with low-dose ketamine	4 weeks
intraoperative complications	Reducing postpartum depression by reducing ketamine-related intraoperative complications	1 day
postoperative pain	Reducing postoperative pain with low dose ketamine	1 day

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: duygu demiröz, Inonu University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: postpartum depression; low dose ketamine; midazolam with low dose ketamine; postoperatıve analgesıc need
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Ketamine; Midazolam
• Other Study ID Numbers: inonu Caesarean

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No