The Effect of Esketamine on Sleep Disturbance

Tianjin Medical University

Status: Completed

Conditions: Sleep Disturbance

Treatments: Drug: Esketamine; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06388824

GWang028

Details and patient eligibility

About

To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance

Full description

Sleep disturbance occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities. Women who requires surgical abortion due to fetal anomaly or unwanted pregnancy often experience sleep disturbance. Severe sleep disturbance is a strong indicator for postoperative sleep disorders, which can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative pain, and delay postoperative recovery.

Esketamine is an N-methyl-D-aspartate(NMDA) receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgical abortion, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on sleep disturbance is worth exploring.

Enrollment: 204 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18 years or older with sleep disturbance;
2. American Society of Anesthesiologists physical status I-III;
3. A gestational age below 12 weeks;
4. Elective surgery is proposed;
5. BMI of 19-30 kg/m2;
6. Patients who agreed to enroll in this study voluntarily

Exclusion criteria

1. Any contraindications to ketamine or esketamine;
2. Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
3. Respiratory insufficiency, respiratory failure;
4. Bronchial asthma, severe hypertension, severe hepatic and renal dysfunction, severe cardiovascular disease, or hyperthyroidism;
5. BMI<18 kg/m2 or BMI>30kg/m2;
6. Poor compliance, unable to complete the experiment according to the study plan; Participants who have participated in clinical trials of other drugs within the last 4 weeks;
7. Any circumstances deemed unsuitable for inclusion by the researcher for any reason.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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204 participants in 2 patient groups, including a placebo group

Placebo Group of patients undergoing surgical abortion with normal saline

Placebo Comparator group

Description:

Patients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery

Treatment:

Drug: normal saline

Group of patients undergoing surgical abortion with esketamine

Active Comparator group

Description:

Patients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery

Treatment:

Drug: Esketamine