Clinical trial NCT06284668: Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety
Official title: Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Oocyte Retrieval
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Keywords: Esketamine
Remimazolam
oocyte retrieval
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval

Detailed description: Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.

Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration. 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 surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance is worth exploring.

Eligibility criteria: Inclusion Criteria:

1. Age 18-45 years old;
2. American society of Aneshesiologists（ASA）physical status classification system is grade I-III;
3. Elective surgery is proposed
4. BMI of 19-30 kg/m2;
5. Patients who agreed to enroll in this study voluntarily

Exclusion Criteria:

1. Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
2. Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
3. History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery
4. Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
5. Respiratory insufficiency, respiratory failure;
6. BMI\<18 kg/m2 or BMI\>30kg/m2;
7. 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;
8. Preoperative Pittsburgh Sleep Quality Index (PSQI) higher than 7
9. Any circumstances deemed unsuitable for inclusion by the researcher for any reason.

Primary outcomes:
measure: The incidence of postoperative sleep disturbance on the first night after surgery
timeFrame: the first night after surgery
Secondary outcomes:
measure: The incidence of sleep disturbance one day before surgery
timeFrame: one day before surgery
measure: The incidence of postoperative sleep disturbance on the second and third postoperative nights
timeFrame: the second and third nights after surgery
measure: Postoperative anxiety
timeFrame: 1 day before surgery ,1 and 2 days after surgery
measure: Postoperative depression
timeFrame: 1 day before surgery ,1 and 2 days after surgery
measure: Pain Score (NRS)
timeFrame: 1 and 2 days after surgery
measure: Mean intraoperative blood pressure
timeFrame: Intraoperative
measure: Oxygen saturation
timeFrame: Intraoperative
measure: Somatokinetic reaction
timeFrame: Intraoperative
measure: Operation time
timeFrame: Intraoperative
measure: Duration of anesthesia
timeFrame: Intraoperative
measure: Time to walking down
timeFrame: Within1 hour after surgery
measure: Adverse event
timeFrame: Within 3 days after 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
role: STUDY_DIRECTOR
References: