The Effect of Esketamine on Sleep Disturbance

This interventional trial (n=200) will investigate the effect of a single low dose of esketamine during surgical abortion in patients with sleep disturbance.

Sleep disturbances, including sleep deprivation and circadian rhythm disturbances, commonly affect patients undergoing surgical abortion, potentially leading to postoperative complications such as delirium and cognitive dysfunction. Esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist with sedative properties, is being explored for its potential to mitigate sleep disturbances during surgical abortion.

Patients aged 18 years or older with sleep disturbances, undergoing elective surgical abortion, and with American Society of Anesthesiologists physical status I-III are eligible to participate. The study, led by Dr. Guolin Wang at Tianjin Medical University General Hospital, will randomly allocate patients into two groups: one receiving a single injection of esketamine and the other receiving a placebo of normal saline.

Outcome measures include assessing the incidence of sleep disturbance on the first, second, third, and seventh postoperative nights, as well as postoperative anxiety, depression, pain intensity, and adverse events. Enrollment is estimated to begin on May 3, 2024, with completion expected by October 10, 2024.

Topic Depression Pain Anxiety
Compound Ketamine Placebo
Country China
Visit trial
Status Not yet recruiting
Results Published No
Start date 03 May 2024
End date 10 October 2024
Phase Not Applicable
Design Blinded
Type Interventional
Generation First
Participants 200
Sex Female
Age 018-
Therapy No

Trial Details

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.

Trial Number NCT06388824

Data attribution

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