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NCT06388824 | Not yet recruiting | Sleep Disturbance

The Effect of Esketamine on Sleep Disturbance
Sponsor:

Tianjin Medical University General Hospital

Information provided by (Responsible Party):

GU Olin Wang

Brief Summary:

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

Condition or disease

Sleep Disturbance

Intervention/treatment

normal saline

Esketamine

Phase

Not Applicable

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
Estimated Enrollment : 200 participants
Masking : Triple
Primary Purpose : Treatment
Official Title : The Effect of a Single Low Dose of Esketamine During Surgical Abortion in Patients With Sleep Disturbance
Actual Study Start Date : May 3, 2024
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : October 10, 2024
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

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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Patients aged 18 years or older with sleep disturbance;
  • American Society of Anesthesiologists physical status I-III;
  • A gestational age below 12 weeks;
  • Elective surgery is proposed;
  • BMI of 19-30 kg/m2;
  • Patients who agreed to enroll in this study voluntarily
Exclusion Criteria
  • Any contraindications to ketamine or esketamine;
  • Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
  • Respiratory insufficiency, respiratory failure;
  • Bronchial asthma, severe hypertension, severe hepatic and renal dysfunction, severe cardiovascular disease, or hyperthyroidism;
  • BMI<18 kg/m2 or BMI>30kg/m2;
  • 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;
  • Any circumstances deemed unsuitable for inclusion by the researcher for any reason.
The Effect of Esketamine on Sleep Disturbance

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The Effect of Esketamine on Sleep Disturbance

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Locations

Not yet recruiting

China,

Tianjin Medical University General Hospital

Tianjin, China, 300052