Dose Low Dose Ketamine in Casesarian

NCT06237569 — Completed, 80 participants, Inonu University

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Effects of Low Dose ketamıne on Postpartum Depression During Caesarean Sections

RegistryNCT06237569, acronym ketamine
StatusCompleted
Study typeObservational
Enrollment80 (Actual)
SponsorInonu University (Other)
ConditionsPostoperative Pain, Postpartum Depression
InterventionsApplication of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia (Drug)
Datesstart 2024-05-01, primary completion 2024-08-01, completion 2024-09-01, first posted 2024-02-01, last updated 2026-10-21
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Pain All trials for Postpartum Depression All trials of Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia

-Summary

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

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+Detailed description

Background: Postpartum depression is a common complication after childbirth and may adversely affect maternal well-being, mother-infant interaction, and child development. Low-dose ketamine has been associated with antidepressant and analgesic effects in the perioperative period; however, its psychomimetic adverse effects may limit its use. Coadministration of midazolam has been proposed to reduce these effects. Evidence on the association of low-dose ketamine, alone or combined with midazolam, with postpartum depressive symptoms, postoperative pain, and adverse events in women undergoing cesarean delivery under spinal anesthesia remains limited.

Design and setting: This is a prospective, nonrandomized, controlled observational cohort study conducted at the Department of Anesthesiology and Reanimation, İnönü University Turgut Özal Medical Center, Malatya, Türkiye. The study was approved by the İnönü University Clinical Research Ethics Committee (decision no. 2024/34).

Group formation: Treatment decisions are made by the attending anesthesiologist as part of routine clinical care, independently of the research protocol. The investigators do not assign or influence treatment. After umbilical cord clamping, intraoperative pain and anxiety are assessed using numerical rating scales (NRS and NRS-A, 0-10). Patients with pain (NRS ≥5) who do not require anxiolytic treatment receive a single intravenous bolus of ketamine 0.5 mg/kg (ketamine group). Patients with both pain and anxiety (NRS ≥5 and NRS-A ≥5) receive intravenous ketamine 0.5 mg/kg and midazolam 0.01 mg/kg (ketamine-midazolam group). Patients who do not require additional analgesic or anxiolytic treatment receive no additional medication (control group). Patients are classified observationally according to the treatment received, with a target of 100 patients per group.

Anesthetic management: All patients receive spinal anesthesia with 0.5% isobaric bupivacaine dosed according to height (0.05 mg/cm) plus 25 µg intrathecal fentanyl. Postoperative analgesia follows the institutional routine protocol, with intravenous morphine as rescue analgesia.

Assessments: Postpartum depressive symptoms are assessed using the Edinburgh Postnatal Depression Scale (EPDS) preoperatively and at postpartum weeks 1, 2, and 4. Postoperative pain is assessed using a visual analog scale, the time to first rescue analgesic requirement is recorded, and intraoperative adverse events are monitored.

Registry history: The study was initially registered as a randomized, placebo-controlled trial. Because the institutional ethics committee did not approve this design, the study was conducted as an observational cohort based on routine clinical practice, and this record has been updated to reflect the approved protocol.

+Arms and interventions

ArmTypeInterventionsDescription
Grup 1 -Ketamine GroupDrug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesiaPatients with intraoperative pain (NRS ≥5) without anxiety requiring treatment, who received a single intravenous bolus of ketamine 0.5 mg/kg after umbilical cord clamping as part of routine clinical care.
Group 2-ketamine + midazolamDrug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesiaTitle: Ketamine-Midazolam Group Description: Patients with intraoperative pain and anxiety (NRS ≥5 and NRS-A ≥5), who received intravenous midazolam 0.01 mg/kg and a single intravenous bolus of ketamine 0.5 mg/kg after umbilical cord clamping as part of routine clinical care..
Grup 3: Control GroupDrug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesiaTitle: Control Group Description: Patients who did not require additional analgesic or anxiolytic treatment after umbilical cord clamping and received no additional medication..
  • Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia (Drug): Single intravenous bolus of ketamine 0.5 mg/kg administered after umbilical cord clamping during cesarean delivery under spinal anesthesia, as part of routine clinical care and independently of the study protocol. Ketamine was given alone to patients with intraoperative pain (NRS ≥5) who did not require anxiolytic treatment, and was preceded by intravenous midazolam 0.01 mg/kg in patients with both intraoperative pain and anxiety (NRS ≥5 and NRS-A ≥5). Treatment decisions were made by the attending anesthesiologist.

+Outcome measures

Primary outcomes

  • Edinburgh Postnatal Depression Scale (EPDS) score [4 weeks postpartum]: Postpartum depressive symptoms assessed using the total score of the Edinburgh Postnatal Depression Scale (range 0-30; higher scores indicate more severe depressive symptoms).

Secondary outcomes

  • Positive screening for postpartum depressive symptoms [eoperatively and at postpartum weeks 1, 2, and 4]: Proportion of patients with an Edinburgh Postnatal Depression Scale (EPDS) score ≥11, indicating a positive screen for postpartum depressive symptoms.
  • Time to first rescue analgesic requirement [24 hours]: ime from the end of surgery to the first administration of rescue analgesia (intravenous morphine for VAS >5), recorded in minutes.

+Eligibility

Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Inonu universitesiMalatyaTurkey (Türkiye)

+Investigators

  • DUYGU DEMIROZ, Principal investigator, Inonu University