The Effect of Esketamine on Sleep Disturbance

Not Applicable

Completed

• Conditions: Sleep Disturbance
• Interventions: Drug: normal saline; Drug: Esketamine

• Registration Number: NCT06388824
• Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-29
• Study Start: 2024-05-03
• Primary Completion: 2024-11-07
• Study Completion: 2024-11-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group of patients undergoing surgical abortion with normal saline	normal saline	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	Esketamine	Patients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery

Primary Outcome Measures

Name	Time	Method
The incidence of sleep disturbance on the first night after surgery	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.

Secondary Outcome Measures

Name	Time	Method
The incidence of sleep disturbance on the seventh postoperative nights	the seventh night after surgery	Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the seventh day 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 seventh postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.
Postoperative depression	1 day before surgery, 1, 2, 3 and 7 days after surgery	Patients completed the depression rating scales (HADS-D,Hospital Anxiety and Depression Scale-Depression subscale) on the day before surgery. HADS-D consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression. And we asked the patients to fill out this questionnaire on the 1, 2, 3 and 7 days after surgery again to evaluate the changes in depression. We recorded HADS-D scores as statistical indicators.
Pain intensity	1 hour after surgery, 1, 2, 3 and 7 days after surgery	The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
The incidence of sleep disturbance on the second and third postoperative nights	the second and third nights after surgery	Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the second and third day 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 second and third postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.
Postoperative anxiety	1 day before surgery, 1, 2, 3 and 7 days after surgery	Patients completed the anxiety rating scales (HADS-A,Hospital Anxiety and Depression Scale-Anxiety subscale) on the day before surgery. HADS-A consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety. And we asked the patients to fill out this questionnaire on the 1, 2, 3 and 7 days after surgery again to evaluate the changes in anxiety. We recorded HADS-A scores as statistical indicators.
Adverse event	Within 1 hour after surgery, within 1 day after surgery	All kinds of adverse events (nausea, vomiting, tachycardia, hypertension, somnolence, dizziness, hallucination, diplopia, etc) occurred in patients were recorded
preoperative hemoglobin concentration	the day before surgery	Hemoglobin concentration in venous blood was measured.
Human Chorionic Gonadotropin level	within one week before surgery, within one week after surgery	Human Chorionic Gonadotropin (HCG) in venous blood was measured.
The incidence of sleep disturbance on the day before surgery	the day before surgery	Patients completed the sleep quality scale (AIS, Athens Insomnia Scale) on the day before 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 on the day before surgery to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.
The incidence of sleep disturbance before surgery	the day before surgery	Patients completed the sleep quality scale (PSQI, Pittsburgh sleep quality index) on the day before surgery. The PSQI has a total of 24 items(Including 19 self-evaluation items and 5 other evaluation items),of which the 19th self-evaluation item and 5 other self-evaluation items do not participate in scoring, while the remaining 18 self-evaluation items participate in scoring, with each item scoring 0-3 points. The total score of the scale ranges from 0 to 21 points, with a total score higher than 5 indicating poor sleep quality. We require patients to fill out this questionnaire one day before surgery to evaluate whether they have had sleep disorders in the past month.We recorded PSQI scores as statistical indicators.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China