elderly patients undergoing painless colonoscopy
Conditions
Interventions
Experimental group:Injection of remimazolam besylate 0.1-0.2 mg/kg
Control group:Injection of propofol 0.3-0.5 mg/kg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily participate in and sign the informed consent form for painless colonoscopy; 2. Age >= 65 years old, regardless of gender; 3. ASA I-III; 4. BMI 18-30 kg/m2; 5. The respiratory rate in the screening period and the baseline period should be >= 10 and = 95% when absorbing air; SBP >= 90 mmHg; DBP >= 60 mmHg The heart rate should be >= 60 and <= 100 beats/min.
Exclusion criteria
Exclusion criteria: 1. Those with contraindications for deep sedation/general anesthesia or those with previous history of sedation/anesthesia accidents; 2. People who are known to be allergic to eggs, soy products, opioids and their rescue drugs, propofol, remazolam besylate, etc.; propofol, benzodiazepines, opioids and their rescues Drug contraindications; 3. Severe liver, kidney, digestive system, blood system, nervous system or metabolic system and other diseases that the researchers judge may increase the risk of sedation/anesthesia and are not suitable for participating in the study; 4. The following respiratory management risks were found during the screening period: (1) History of asthma, wheezing; (2) People with sleep apnea syndrome; (3) Have a history of malignant hyperthermia or family history; (4) Those who have failed tracheal intubation experience; (5) Difficult airway or difficulty in tracheal intubation as judged by the investigator during screening (modified Matheson score is grade IV); 5. Those who participated in any drug clinical research within 1 month before screening; patients who used opioids and sedative/anesthetic drugs 3 days before diagnosis and treatment; 6. Subjects who, in the opinion of the investigator, have any other factors that are not suitable for participating in this clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of intraoperative hypotension; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;Time between the start of anesthesia and the patient's expiration;Summarize colonoscopy times;Awakening time;Time from patient awakening to leaving the operating room;Ramsay sedation score;Whether the patient shows somatic movements and the number of somatic movements;Total dosage of propofol or remimazolam besylate;Frequency and dose of additional intraoperative drug administration;Hypotension;Cognitive function evaluation;Satisfaction score;Adverse reactions; | — |
Countries
China
Contacts
Public ContactXiao Wang
West China Hospital, Sichuan University
Outcome results
None listed