Cholelithiasis/Cholecystitis/Sleep Disorders
Conditions
Interventions
Saline Group:Intranasal Saline
Dexmedetomidine Group:Intranasal Dexmedetomidine
Sponsors
Drum Tower Hospital Affiliated to Nanjing University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-65 years; 2.Scheduled for Laparoscopic Cholecystectomy under General Anesthesia; 3.Consent to Participate in This Study and Sign the Informed Consent Form;
Exclusion criteria
Exclusion criteria: 1.Refusal to Participate in This Study; 2.Patients with the following conditions are excluded: - Sick sinus syndrome, severe sinus bradycardia (heart rate =III. 3.Patients with preoperative diagnosis of sleep apnea, or those with a STOP-Bang score >=3 and serum bicarbonate (HCO3-) >=28 mmol/L. 4.Patients who are not suitable for intranasal administration, such as those with severe rhinitis, nasal deformities, or other conditions that may interfere with intranasal drug delivery. 5.Patients with a preoperative Pittsburgh Sleep Quality Index (PSQI) score higher than 7. 6.Patients who have taken sedatives or hypnotics within one month prior to surgery. 7.Patients with an allergy to dexmedetomidine. 8.Patients with a body mass index (BMI) greater than 30 kg/m^2. 9.Patients with the following conditions are excluded: - Severe liver dysfunction (Child-Pugh Class C); - Severe renal dysfunction (requiring preoperative dialysis); - American Society of Anesthesiologists (ASA) physical status classification >=IV. 10.Patients who are unable to comprehend the visual analog scale or have language communication barriers. 11.Other conditions where the investigator or the attending physician deems the patient unsuitable for participation in the study. 12.Pregnant or breastfeeding women. 13.Patients currently participating in other interventional clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of PSD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative Day 1 Quality of Recovery (QoR-15);The PACU (Post-Anesthesia Care Unit) records adverse events during anesthesia recovery, including nausea and vomiting, hypoxemia, blood pressure fluctuations, intraoperative awareness, somnolence, and;Severity of nausea within 24 hours after surgery;The Huawei Watch D2 will be used to monitor sleep duration, blood pressure, and pulse oxygen saturation.;Sleep score on postoperative day 3;Incidence of adverse events in the PACU;Anxiety and depression on postoperative day 1;Incidence of complications within 30 days after surgery;The rate of rehospitalization within 30 days after surgery.;Pain score at postoperative day 30;Incidence of PONV (Postoperative Nausea and Vomiting) within 24 hours after surgery;The number of vomiting episodes within 24 hours after surgery, including retching.;Postoperative 30-day sleep score;Postoperative opioid analgesic consumption;Pain scores on postoperative days 1 and 3, assessed using the pain Numerical Rating Scale (NRS), including both resting and movement NRS scores; | — |
Countries
China
Contacts
Public ContactXiaoping Gu
Drum Tower Hospital Affiliated to Nanjing University School of Medicine
Outcome results
None listed