The Effect of Esketamine on Sleep Disturbance

Tianjin Medical University General Hospital204 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

204

Conditions

Sleep Disturbance

Interventions

normal salineDRUG

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

EsketamineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tianjin Medical University General Hospital

Tianjin, China

Outcomes

Primary Outcomes

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.

Time frame: the first night after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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