Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients
- Conditions
- Sleep Disturbance
- Interventions
- Registration Number
- NCT06108830
- Lead Sponsor
- Tianjin Medical University General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group of patients undergoing gastroenteroscopies with normal saline normal saline Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began Group of patients undergoing gastroenteroscopies with esketamine Esketamine Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began Group of patients undergoing gastroenteroscopies with remimazolam and esketamine Esketamine and remimazolam Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began Group of patients undergoing gastroenteroscopies with remimazolam Remimazolam Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
- Primary Outcome Measures
Name Time Method Sleep disturbance and anxiety after surgery 1 day before surgery, 1 and 3 days after surgery Patients completed the sleep quality (AIS, Athens Insomnia Scale) and anxiety (Hospital Anxiety and Depression Scale) rating scales on the day before surgery. HADS consists of 14 items to calculate the patient's comprehensive score, including 7 anxiety related scores and 7 depression related scores. Each question in the questionnaire was scored on a scale of 0-3, so patients scored 0-21 on both anxiety and depression. Scores of 8 points or higher are diagnosed as depression or anxiety.And we asked the patients to fill out these questionnaires on the day 1 and 3 after surgery again to evaluate the changes in sleep quality and anxiety. (The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia). . We recorded AIS scores, HDS-A scores and HDS-D scores as separate statistical indicators.
- Secondary Outcome Measures
Name Time Method Pain Score (NRS) 1 and 3 days after surgery The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
Incidence of injection pain Intraoperative The frequency of injection pain induced by propofol was recorded
Dosage of drug Intraoperative The dosage of propofol, esketamine and remimazolam were recorded
Mean intraoperative blood pressure Intraoperative The mean intraoperative blood pressure was recorded
Oxygen saturation Intraoperative The mean intraoperative oxygen saturation was recorded
Somatokinetic reaction Intraoperative The number of intraoperative body movements was recorded
Operation time Intraoperative The duration of the patient's operation was recorded(up to 24 h)
Duration of anesthesia After surgery The patient's duration of anesthesia was recorded(up to 24 h)
Time of awakening After surgery The duration from the end of anesthesia to recovery was recorded(up to 24 h)
Time to walking down After surgery Record the time from waking up to walking down(up to 24 h)
Adverse event Within 3 days after surgery All kinds of adverse events occurred in patients were recorded
Exhaust time Within 3 days after surgery Records from end of anesthesia to patients with postoperative exhaust time for the first time
Trial Locations
- Locations (1)
Tianjin Medical University General Hospital
🇨🇳Tianjin, China