Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
150 participants
OBSERVATIONAL
2024-06-01
2024-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Grup 1 -Ketamine Group
Ketamine Group (GROUP 1) 0.5 mg/kg IV single dose bolus diluted to 5 ml with 0.9% saline
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
ExclusionCriteria:
Pathological obstetric complications
Hypertension
Contraindication for ketamine Contraindication for spinal
18 Years
45 Years
FEMALE
Yes
Sponsors
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Inonu University
OTHER
Responsible Party
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DUYGU DEMİROZ
principal investigator
Principal Investigators
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DUYGU DEMIROZ
Role: PRINCIPAL_INVESTIGATOR
Inonu University
Locations
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Inonu universitesi
Malatya, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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inonu Caesarean
Identifier Type: -
Identifier Source: org_study_id
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