remimazolam-remifentanil: For elderly patients scheduled for elective painless gastro-intestinal endoscopy, remimazolam 0.2mg/kg and remifentanil 0.2ug/kg are used for anesthesia induction. During the operation, the doses are adjusted according to the depth of sedation of the patients.
remimazolam-esketamine: For elderly patients scheduled for painless gastroenterological endoscopy, remimazolam 0.2mg/kg and esketamine 0.15mg/kg are used for anesthesia induction. During the operation, the dosage is adjusted according to the patient's level of sedation.
Study summary
The objective of this clinical trial is to assess the feasibility of the remimazolam combined with esketamine OFA (opioid-free anesthesia) protocol for painless gastroscopy and colonoscopy in elderly patients and to determine if it is non-inferior to the traditional OA (opioid-containing anesthesia) protocol. The main questions it aims to answer are:
* Is the remimazolam combined with esketamine protocol feasible for painless gastroscopy and colonoscopy in elderly patients?
* Is the OFA protocol superior to the OA protocol?
Participants will:
* During anesthesia induction, the experimental group will receive remimazolam combined with esketamine for anesthesia, while the control group will receive remimazolam combined with remifentanil.
* Record respiratory and circulatory indicators and adverse reaction times.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients undergoing painless gastroenteroscopy in outpatient clinics;
2. aged 65 years and above;
3. American Society of Anesthesiologists (ASA) grades I - III.
Exclusion Criteria:
1. Patients with abnormal liver or kidney function;
2. known respiratory or endocrine diseases;
3. Patients with uncontrolled hypertension and NYHA classification Ⅲ-Ⅳ;
4. Taking monoamine oxidase inhibitors, sedatives, analgesics, hypnotics, antipsychotics, antiemetics or antidepressants;
5. Addiction to tobacco and alcohol;
6. Patients allergic to the investigational drug;
7. expected difficult airway;
8. Body mass index (BMI) \>35kg/m\^2;
9. Have participated in other clinical trials within the past three months;
10. Patients with psychosocial illness or cognitive dysfunction and inability to cooperate or communicate.
Primary outcome measure(s)
Sedation success rate — From the start of anesthesia induction to the end of the surgery Successful sedation：① The patient underwent painless gastroenteroscopy;②During anesthesia induction, a single remazolam is not enough to achieve sufficient sedation depth, and it needs to be remedied, and the number of remediations within 15min is less than 5 times; Intraoperative supplementary times ≤5 times within any 15min.③ The patient did not use rescue drugs;Sedation success rate: Number of patients successfully sedated/total number of patients included in the data analysis for this group
Incidence of hypotension — From the start of anesthesia induction to the end of the surgery Hypotension: systolic blood pressure below 80% of baseline systolic blood pressure or MAP below 80% of baseline MAP; Incidence of hypotension: Number of patients with intraoperative hypotension/total number of patients included in the data analysis for this group
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Harbin Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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