Clinical trial NCT06388824: The Effect of Esketamine on Sleep Disturbance
Official title: The Effect of a Single Low Dose of Esketamine During Surgical Abortion in Patients With Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Keywords: Esketamine
surgical abortion
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of sleep disturbance on the first night after surgery
timeFrame: the first night after surgery
Secondary outcomes:
measure: The incidence of sleep disturbance on the second and third postoperative nights
timeFrame: the second and third nights after surgery
measure: The incidence of sleep disturbance on the seventh postoperative nights
timeFrame: the seventh night after surgery
measure: Postoperative anxiety
timeFrame: 1 day before surgery, 1, 2, 3 and 7 days after surgery
measure: Postoperative depression
timeFrame: 1 day before surgery, 1, 2, 3 and 7 days after surgery
measure: Pain intensity
timeFrame: 1 hour after surgery, 1, 2, 3 and 7 days after surgery
measure: Adverse event
timeFrame: Within 1 hour after surgery, within 1 day after surgery
measure: preoperative hemoglobin concentration
timeFrame: the day before surgery
measure: Human Chorionic Gonadotropin level
timeFrame: within one week before surgery, within one week after surgery
measure: The incidence of sleep disturbance on the day before surgery
timeFrame: the day before surgery
measure: The incidence of sleep disturbance before surgery
timeFrame: the day before surgery
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Guolin Wang, MD, PhD
role: STUDY_DIRECTOR
References: