Status:
RECRUITING
Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Sleep Disturbance
Eligibility:
All Genders
20-65 years
Phase:
NA
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. Post...
Eligibility Criteria
Inclusion
- Age 20-65 years old;
- ASA classification is grade I-III;
- Elective surgery is proposed
- BMI of 19-30 kg/m2;
- Patients who agreed to enroll in this study voluntarily
Exclusion
- Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
- Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- 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;
- ASA rating of IV or V;
- Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
- History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);
- Respiratory insufficiency, respiratory failure;
- Patients who refused to use intravenous PCA for analgesia;
- Pregnant or lactating women;
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06108830
Start Date
December 1 2023
End Date
December 10 2024
Last Update
September 4 2024
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, China, 300052