None
Conditions
Interventions
Remimazolam patient-controlled sedation group:After the anesthesia plane stabilizes (at the T8-T10 level), the medication is administered at the beginning of the surgery. Remimazolam is prepared at a
Remifentanil conventional sedation group:After the anesthesia plane stabilizes (at the T8-T10 level), the medication is administered at the beginning of the surgery. Remimazolam is prepared at a conce
Sponsors
The Second Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Approved by the ethics committee and with written informed consent from the patient (or the authorized representative); 2. American Society of Anesthesiologists classification: ASA grades II - III; 3. Age >= 65 years; 4. Body Mass Index (BMI) 18.5 - 27.9 kg/m2; 5. Meets the standards for lower limb surgery and can tolerate the surgery, with a surgery duration of 1 - 3 hours.
Exclusion criteria
Exclusion criteria: 1. There are patients with abnormal coagulation function or those who have taken anticoagulant drugs before the operation, as well as those who switch to general anesthesia due to various reasons during the operation, and those with expected difficult airways; 2. Those who are allergic to the drugs that may be used in the trial, or have contraindications for drug use; 3. Those who have taken sedative, hypnotic and antidepressant drugs for a long time in the past; 4. Those with liver and kidney dysfunction and abnormal heart and lung functions; 5. Those with mental disorders or cognitive dysfunction and communication disorders, or those without the ability to control their own operations; 6. Combined with malignant tumors in other tissues of the body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug-related information (time to achieve Ramsay sedation score of 3-4 and remifentanil dosage, time to regain consciousness after sedation, and the amount of remifentanil used during the operation);The number of presses/number of effective times (N/E) of the patients in the remimazolam patient-controlled sedation group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean arterial pressure;Heart rate;Saturation of pulse oximetry;Ramsay Sedation Score;Airway score;Bispectral index;Anesthesia and surgical characteristics (anesthesia duration, surgery duration, administration time);Adverse reaction;Patient subjective scores (patient satisfaction, comfort level, cooperation degree); | — |
Countries
China
Contacts
Public ContactDajiang Yuan/Mei Wang
The Second Hospital of Shanxi Medical University
Outcome results
None listed