Postoperative PainketamineNCT06237569
Dose Low Dose Ketamine in Casesarian
An observational study of Postoperative Pain and Postpartum Depression, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The results of ketamine, ketamine and midazolom can be copied after birth in cesareans subjected to spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postpartum Depression
- What is being tested?
- Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing cesarean section under spinal anesthesia
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low Dose ketamıne on Postpartum Depression During Caesarean Sections
The results of ketamine, ketamine and midazolom can be copied after birth in cesareans subjected to spinal anesthesia.
Read the 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.
- Conditions
- Postoperative Pain, Postpartum Depression
- Being tested
- Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia
- Keywords
- midazolam with low dose ketamine, low dose ketamine, postoperatıve analgesıc need, postpartum depression
- Medical subject headings
- Pain, Postoperative, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Grup 1 -Ketamine Group | Patients 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. Receives: Drug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia | |
| Group 2-ketamine + midazolam | Title: 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.. Receives: Drug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia | |
| Grup 3: Control Group | Title: Control Group
Description:
Patients who did not require additional analgesic or anxiolytic treatment after umbilical cord clamping and received no additional medication.. Receives: Drug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale (EPDS) score
Postpartum depressive symptoms assessed using the total score of the Edinburgh Postnatal Depression Scale (range 0-30; higher scores indicate more severe depressive symptoms).
Measured: 4 weeks postpartum
Secondary outcomes (2)
Positive screening for postpartum depressive symptoms
Proportion of patients with an Edinburgh Postnatal Depression Scale (EPDS) score ≥11, indicating a positive screen for postpartum depressive symptoms.
Measured: eoperatively and at postpartum weeks 1, 2, and 4
Time to first rescue analgesic requirement
ime from the end of surgery to the first administration of rescue analgesia (intravenous morphine for VAS >5), recorded in minutes.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 May 2024
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUYGU DEMİROZ, Inonu University
- Investigators
- DUYGU DEMIROZ, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237569
- Sponsor's protocol ID
- inonu Caesarean
- Acronym
- ketamine
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Dose ketamıne on Postpartum Depression During Caesarean Sections
- ClinicalTrials.gov ID
- NCT06237569
- Acronym / sponsor ID
- ketamine / inonu Caesarean
- Conditions
- Postoperative Pain, Postpartum Depression
- Keywords
- midazolam with low dose ketamine, low dose ketamine, postoperatıve analgesıc need, postpartum depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The results of ketamine, ketamine and midazolom can be copied after birth in cesareans subjected to spinal anesthesia.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grup 1 -Ketamine Group | – | Drug: 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 + midazolam | – | Drug: 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 Group | – | Drug: 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.. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing cesarean section under spinal anesthesia
Key inclusion criteria (5 listed)
- 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
- Pathological obstetric complications
- Hypertension
- Contraindication for ketamine Contraindication for spinal
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesiaSingle 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. | Drug | Group 2-ketamine + midazolam, Grup 1 -Ketamine Group, Grup 3: Control Group |
Primary outcome
Edinburgh Postnatal Depression Scale (EPDS) score
Time frame: 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).
2 secondary outcomes
Positive screening for postpartum depressive symptoms
Time frame: eoperatively and at postpartum weeks 1, 2, and 4
Time to first rescue analgesic requirement
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DUYGU DEMIROZ principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Postpartum Depression, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (EPDS) score (time frame: 4 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.