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

Peking University

Status and phase: Completed; Phase 4

Conditions: Neuropsychiatric Symptoms; Esketamine; Dexmedetomidine; Cesarean Delivery

Treatments: Drug: Esketamine 0.2 mg/kg; Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg; Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg; Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT06613243

2024-468

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

Esketamine 0.2 mg/kg

Active Comparator group

Description:

Esketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.

Treatment:

Drug: Esketamine 0.2 mg/kg

Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg

Experimental group

Description:

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.

Treatment:

Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg

Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg

Experimental group

Description:

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.

Treatment:

Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg

Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg

Experimental group

Description:

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.

Treatment:

Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg