Clinical TrialSafety & Risk ManagementEsketaminePlaceboCompleted

The Effect of Esketamine on Sleep Disturbance

Randomised, triple-blind, parallel-group trial (n=204) testing a single 0.2 mg/kg IV esketamine injection versus 5 ml 0.9% saline in females undergoing surgical abortion with sleep disturbance.

Target Enrollment
204 participants
Study Type
Phase NA interventional
Design
Randomized, triple Blind

Detailed Description

This parallel-group, randomised, triple-blind study evaluates whether a single low dose of esketamine given during surgical abortion improves sleep disturbance in women (gestation <12 weeks).

Participants receive a single intravenous injection of esketamine 0.2 mg/kg or 5 ml 0.9% normal saline after the beginning of surgery; outcomes include measures of sleep disturbance, postoperative recovery, delirium and pain.

Safety and tolerability will be monitored intraoperatively and postoperatively; primary purpose is treatment of sleep disturbance associated with surgical abortion.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Esketamine

experimental

Single IV 0.2 mg/kg esketamine administered after start of surgery.

Interventions

  • Esketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    Single injection after beginning of surgery

Placebo (saline)

inactive

Single IV 5 ml 0.9% normal saline administered after start of surgery.

Interventions

  • Placebo5 ml
    via IV• single dose• 1 doses total

    5 ml 0.9% normal saline

Participants

Ages
18 – 99
Sexes
female

Inclusion 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

  • 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 >30 kg/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 Details

Locations

Tianjin Medical University General Hospital — Tianjin, China

Your Library