Clinical trial NCT06108830: Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients
Official title: Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Keywords: Esketamine
remimazolam
anxiety
gastroenteroscopy
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies

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 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 and anxiety is worth exploring.

Eligibility criteria: Inclusion Criteria:

1. Age 20-65 years old;
2. ASA classification 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. ASA rating of IV or V;
5. Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
6. History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);
7. Respiratory insufficiency, respiratory failure;
8. Patients who refused to use intravenous PCA for analgesia;
9. Pregnant or lactating women;
10. BMI\<18 kg/m2 or BMI\>30kg/m2;
11. Poor compliance, unable to complete the experiment according to the study plan;
12. Participants who have participated in clinical trials of other drugs within the last 4 weeks;
13. Any circumstances deemed unsuitable for inclusion by the researcher for any reason.

Primary outcomes:
measure: Sleep disturbance and anxiety after surgery
timeFrame: 1 day before surgery, 1 and 3 days after surgery
Secondary outcomes:
measure: Pain Score (NRS)
timeFrame: 1 and 3 days after surgery
measure: Incidence of injection pain
timeFrame: Intraoperative
measure: Dosage of drug
timeFrame: Intraoperative
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: After surgery
measure: Time of awakening
timeFrame: After surgery
measure: Time to walking down
timeFrame: After surgery
measure: Adverse event
timeFrame: Within 3 days after surgery
measure: Exhaust time
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: