Different Doses of Dexmedetomidine Combined With Esketamine in Women Undergoing Cesarean Delivery

December 25, 2024 updated by: Dong-Xin Wang, Peking University First Hospital

Different Doses of Dexmedetomidine Combined With Esketamine for Analgesia in Women Undergoing Cesarean Delivery: a Pilot Randomized Trial

Esketamine is a commonly used analgesic during cesarean delivery, but may produce transient neuropsychiatric symptoms. Dexmedetomidine has both sedative and analgesic effects. When used in combination with esketamine, dexmedetomidine can reduce esketamine related neuropsychiatric effects after general anesthesia. The investigator speculate that combining low-dose dexmedetomidine with esketamine may also reduce neuropsychiatric adverse effects of esketamine in women undergoing cesarean section. This pilot trial is designed to determine the minimum dose of dexmedetomidine that can effectively prevent neuropsychiatric side effects of antidepressive dose esketamine (0.2mg/kg) in women undergoing cesarean delivery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Esketamine is a commonly used anesthetic and analgesic drug during the perioperative period. Recent studies found that low-dose esketamine has rapid onset antidepressant effects and reduces postpartum depression when administered during cesarean delivery. However, even low-dose esketamine produces transient neuropsychiatric symptoms.

Dexmedetomidine is a high selective alpha2-adrenoceptor agonist and has both sedative and analgesic effects. When used in combination with esketamine, dexmedetomidine reduces esketamine related neuropsychiatric adverse reactions in patients undergoing general anesthesia.

The investigator speculate that combining low-dose dexmedetomidine with esketamine may also reduce neuropsychiatric adverse effects of esketamine in women undergoing cesarean delivery. The purpose of this pilot trial is to determine the minimum dose of dexmedetomidine that can effectively prevent neuropsychiatric side effects of antidepressve dose esketamine (0.2mg/kg) in women undergoing cesarean delivery.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Pregnant women aged ≥18 years.
  • Scheduled for elective or emergency cesarean delivery under neuraxial anesthesia.

Exclusion criteria:

  • A previous history of schizophrenia;
  • Severe complications of pregnancy, such as pre-eclampsia, placenta accreta spectrum, or HELLP (intravascular haemolysis, elevated liver enzymes, and low platelet count) syndrome; or American Society of Anesthesiologists classification III or higher;
  • Any contraindications to ketamine or esketamine, such as refractory hypertension, severe cardiovascular disease, or hyperthyroidism;
  • Any contraindications to dexmedetomidine, such as sick sinus syndrome, severe sinus bradycardia (<50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
  • Other conditions that are considered unsuitable for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Esketamine 0.2 mg/kg
Esketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Drug: Esketamine 0.2 mg/kg
Esketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Experimental: Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg
A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.1 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg
A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.1 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Experimental: Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg
A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.15 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg
A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.15 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Experimental: Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg
A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.2 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg
A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.2 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dissociation within 24 hours.
Time Frame: Up to 24 hours after study drug infusion.
Dissociative symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion. A CADSS score of >4 points at any timepoint indicates occurrence of dissociative symptoms.
Up to 24 hours after study drug infusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of dissociative symptoms at different timepoints within 24 hours.
Time Frame: Up to 24 hours after study drug infusion.
Dissociation symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion.
Up to 24 hours after study drug infusion.
Prevelance of dissociation at different timepoints within 24 hours.
Time Frame: Up to 24 hours after study drug infusion.
Dissociation symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion.
Up to 24 hours after study drug infusion.
Incidence of neuropsychiatric adverse events within 24 hours.
Time Frame: Up to 24 hours after study drug infusion.
Neuropsychiatric symptoms are evaluated with a structured checklist at 5-minute intervals during, at 10-minute intervals after, and at 2 and 24 hours after study drug infusion. Severity of symptoms is classified as mild (report symptoms on inquiry), moderate (report symptoms without inquiry), or severe (required intervention such as stop study drug infusion and/or give medications). A severity of moderate or above is recorded as presence of neuropsychiatric symptoms.
Up to 24 hours after study drug infusion.
Prevalence of neuropsychiatric adverse events at different timepoints within 24 hours.
Time Frame: Up to 24 hours after study drug infusion.
Neuropsychiatric symptoms are evaluated with a structured checklist every 5 minutes during, every 10 minutes after, and at 2 and 24 hours after study drug infusion. Severity of symptoms is classified as mild (report symptoms on inquiry), moderate (report symptoms without inquiry), or severe (required intervention such as stop study drug infusion and/or give medications). A severity of moderate or above is defined as presence of neuropsychiatric symptoms.
Up to 24 hours after study drug infusion.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of sedation within 24 hours.
Time Frame: Up to 24 hours after study drug infusion.
Agitation-sedation level is assessed with the Richmond Agitation-Sedation Scale (RASS, score ranges from -5 [unarousable] to 4 [combative] and 0 indicates alert and calm) and recorded every 5 minutes during, every 10 minutes after, and at 2 hours and 24 hours after study drug infusion. A RASS score of <-1 is defined as presence of sedation.
Up to 24 hours after study drug infusion.
Pain intensity within 7 days postpartum.
Time Frame: Up 7 days postpartum.
Pain intensity is assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain), both at rest and with movement, at 2 and 24 hours after study drug infusion and at 7 days postpartum.
Up 7 days postpartum.
Proportion of exclusive breastfeeding.
Time Frame: Up to 7 days postpartum.
Proportion of exclusive breastfeeding at 24 hours and 7 days postpartum.
Up to 7 days postpartum.
Length of stay in hospital after surgery.
Time Frame: Up to 7 days postpartum.
Length of stay in hospital after surgery.
Up to 7 days postpartum.
Maternal and neonatal complications within 7 days.
Time Frame: Up to 7 days postpartum.
Maternal and neonatal complications are defined as any medical conditions that required hospital visits and therapeutic intervention.
Up to 7 days postpartum.
Maternal depression score at 7 days postpartum.
Time Frame: At 7 days postpartum.
Maternal depression is assessed with the Edinburgh Postnatal Depression Scale (EPDS; scores range from 0 to 30, with higher score indicating more severe depression) at 7 days postpartum. An EPDS score of ≥10 is defined as having depressive symptoms.
At 7 days postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, M.D., PhD., Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Actual)

December 2, 2024

Study Completion (Actual)

December 9, 2024

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 25, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-468

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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