The Effect of Esketamine on Sleep Disturbance

The Effect of a Single Low Dose of Esketamine During Surgical Abortion in Patients With Sleep Disturbance

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disturbance
• Intervention / Treatment: Drug: normal saline; Drug: Esketamine

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guolin Wang, MD, PhD; Phone Number: +8618604755166; Email: wangguolinghad@hotmail.com

Study Locations

• China
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Drug: normal saline; Patients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery; Other Names: sodium chloride injection
Active Comparator: 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	Drug: Esketamine; Patients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery; Other Names: Esketamine Hydrochloride Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of sleep disturbance on the second and third postoperative nights	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.	the second and third nights after surgery
The incidence of sleep disturbance on the seventh postoperative nights	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.	the seventh night after surgery
Postoperative anxiety	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.	1 day before surgery, 1, 2, 3 and 7 days after surgery
Pain intensity	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.	1 hour after surgery, 1, 2, 3 and 7 days after surgery
Adverse event	All kinds of adverse events (nausea, vomiting, tachycardia, hypertension, somnolence, dizziness, hallucination, diplopia, etc) occurred in patients were recorded	Within 1 hour after surgery, within 1 day after surgery
preoperative hemoglobin concentration	Hemoglobin concentration in venous blood was measured.	the day before surgery
Human Chorionic Gonadotropin level	Human Chorionic Gonadotropin (HCG) in venous blood was measured.	within one week before surgery, within one week after surgery
The incidence of sleep disturbance on 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 day before surgery
The incidence of sleep disturbance 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.	the day before surgery
Postoperative depression	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.	1 day before surgery, 1, 2, 3 and 7 days after surgery

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital
• Investigators: Study Director: Guolin Wang, MD, PhD, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 3, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 10, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Esketamine; surgical abortion
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: GWang028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No