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.
Patients undergoing painless gastroenteroscopy in outpatient clinics;
aged 65 years and above;
American Society of Anesthesiologists (ASA) grades I - III.
Patients with abnormal liver or kidney function;
known respiratory or endocrine diseases;
Patients with uncontrolled hypertension and NYHA classification Ⅲ-Ⅳ;
Taking monoamine oxidase inhibitors, sedatives, analgesics, hypnotics, antipsychotics, antiemetics or antidepressants;
Parallel
remimazolam-remifentanil
Combination productFor 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
Combination productFor 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.
Sedation success rate
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
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
degree of blood oxygen saturation
The blood oxygen saturation was recorded every 2 minutes during the operation. The maximum value is 100. An event where blood oxygen saturation drops below 90 is described as respiratory depression.
respiratory rate
The respiratory rate was recorded every 2 minutes during the operation. The normal breathing rate is 12 to 20 breaths per minute.
bispectral index
During the surgery, the bilateral frequency index of brain electricity was recorded every 2 minutes. The bispectral index of electroencephalogram is mainly used to assess the depth of sedation, the effect of anesthesia and the state of consciousness. Its value range is from 0 to 100. The higher the value, the higher the degree of consciousness; the lower the value, the deeper the degree of brain inhibition.
Heart rate
The heart rate was recorded every 2 minutes during the operation. The normal heart rate is 60 to 100 beats per minute.
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Harbin Medical University
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Collaborator
