The Effect of Esketamine on Sleep Disturbance

NCT06388824 | Completed DMC

• 1 other identifier: GWang028
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Disturbance

Keywords

Esketamine; surgical abortion

Outcome Measures

Primary Outcomes (1)

• The incidence of sleep disturbance on the first night after surgery

  Patients completed the sleep quality scale (AIS, Athens Insomnia Scale) on the first night after surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the first postoperative night to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.

  the first night after surgery

Secondary Outcomes (10)

• The incidence of sleep disturbance on the second and third postoperative nights

  the second and third nights after surgery

• The incidence of sleep disturbance on the seventh postoperative nights

  the seventh night after surgery

• Postoperative anxiety

  1 day before surgery, 1, 2, 3 and 7 days after surgery

• Postoperative depression

  1 day before surgery, 1, 2, 3 and 7 days after surgery

• Pain intensity

  1 hour after surgery, 1, 2, 3 and 7 days after surgery

Study Arms (2)

Placebo Group of patients undergoing surgical abortion with normal saline

PLACEBO COMPARATOR

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

Drug: normal saline

Group of patients undergoing surgical abortion with esketamine

ACTIVE COMPARATOR

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

Drug: Esketamine

Interventions

normal saline DRUG

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

Also known as: sodium chloride injection

Placebo Group of patients undergoing surgical abortion with normal saline

Esketamine DRUG

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

Also known as: Esketamine Hydrochloride Injection

Group of patients undergoing surgical abortion with esketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any contraindications to ketamine or esketamine;
• Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
• Respiratory insufficiency, respiratory failure;
• Bronchial asthma, severe hypertension, severe hepatic and renal dysfunction, severe cardiovascular disease, or hyperthyroidism;
• BMI\<18 kg/m2 or BMI\>30kg/m2;
• 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;

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Related Publications (1)

• Song Z, Miao M, Huang F, Hu L, Yang X, Cui W, Yu Y, Wang G, Wang C, Zhang L. Effect of a single low-dose esketamine administration during surgical abortion on postoperative sleep disturbance: a randomized controlled trial. Nat Commun. 2025 Aug 14;16(1):7533. doi: 10.1038/s41467-025-62933-1.

  PMID: 40804260 DERIVED

MeSH Terms

Conditions

Parasomnias

Interventions

Saline Solution; Sodium Chloride; Esketamine

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Guolin Wang, MD, PhD

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: May 3, 2024
• Primary Completion: November 7, 2024
• Study Completion: November 13, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)