Tianjin Medical University General Hospital
Tianjin, 300052, China
Location status: Recruiting
NCT Number: NCT06108830
To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies
Interested in participating?
Request Info20 year–65 year
All sexes
Interventional
Not applicable
Tianjin, 300052, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began
Other names: Group of patients undergoing gastroenteroscopies with esketamine
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
Other names: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
Other names: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg, esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began
Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began
Other names: Group of patients undergoing gastroenteroscopies with normal saline
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative
The frequency of injection pain induced by propofol was recorded
Time frame: Intraoperative
The dosage of propofol, esketamine and remimazolam were recorded
Time frame: Intraoperative
The mean intraoperative blood pressure was recorded
Time frame: Intraoperative
The mean intraoperative oxygen saturation was recorded
Time frame: Intraoperative
The number of intraoperative body movements was recorded
Time frame: Intraoperative
The duration of the patient's operation was recorded(up to 24 h)
Time frame: After surgery
The patient's duration of anesthesia was recorded(up to 24 h)
Time frame: After surgery
The duration from the end of anesthesia to recovery was recorded(up to 24 h)
Time frame: After surgery
Record the time from waking up to walking down(up to 24 h)
Time frame: Within 3 days after surgery
All kinds of adverse events occurred in patients were recorded
Time frame: Within 3 days after surgery
Records from end of anesthesia to patients with postoperative exhaust time for the first time
Contact information is provided by the study sponsor or research team.
Tianjin Medical University General Hospital
Other
Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies
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