The Effect of Esketamine on Sleep Disturbance

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-03

Study Completion Date

2024-11-13

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo Group of patients undergoing surgical abortion with normal saline

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Group of patients undergoing surgical abortion with esketamine

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

Group Type ACTIVE_COMPARATOR

Esketamine

Intervention Type DRUG

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

Interventions

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normal saline

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

Intervention Type DRUG

Esketamine

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

Intervention Type DRUG

Other Intervention Names

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sodium chloride injection Esketamine Hydrochloride Injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No