Gastrointestinal diseases
Conditions
Interventions
Remimazolam group(R):Sedation with remimazolam
Ciprofol group(C):Sedation with ciprofol
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Elderly patients aged 65-80 years; 2.scheduled for sedation gastroscopy, colonoscopy or combined gastroenteroscopy at the Endoscopy Center of The Second Xiangya Hospital of CSU; 3.American Society of Anesthesiologists (ASA) physical status classification I, II or III; 4.Clear consciousness, able to communicate normally and cooperate with preoperative evaluation and postoperative follow-up;
Exclusion criteria
Exclusion criteria: 1.Patients with American Society of Anesthesiologists (ASA) physical status classification IV or above; 2.Patients with severe dysfunction of important organs such as heart, lung, liver, kidney or brain. 3.Patients with preoperative pulse oxygen saturation (SpO2)<94%; 4.Patients with a history of allergy or contraindication to benzodiazepines, ciprofol or alfentanil; 5.Patients with severe mental illness or cognitive dysfunction who cannot cooperate with the research process; 6.Patients who have participated in other drug clinical trials in the recent 3 months; 7.Patients deemed ineligible for the study (e.g., acute stage of massive upper gastrointestinal bleeding).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypoxemia during perioperative period;Loss of thoracic movement>15 seconds;Respiratory rate 30 seconds; | — |
Secondary
| Measure | Time frame |
|---|---|
| completely awake,acute changes in consciousness, altered attention, difficulty concentrating, confusion, drowsiness;Dizziness, Palpitations,nausea,vomit;Abdominal pain, abdominal distension;bradyarrhythmia,tachyrhythmia;Satisfaction scores of patients,Endoscopist and anesthesiologist;Incidence of hypotension,Hypertension;Onset time of sedation,awakening time;Total dosage of the sedative drug, number of additional drug administrations;incidence of choking and gag reflex;Body movement;Injection pain;singultus;Measures taken after the occurrence of hypoxemia;Weakness in the limbs;Dosage and frequency of vasoactive drugs; | — |
Countries
China
Contacts
Public ContactXinyu Ma
Second Xiangya Hospital of CSU
Outcome results
None listed