This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.
Objective This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes. Methods The investigators will conduct a prospective, randomized, single-center study. Eligible patients will be randomly allocated into three groups: the first group receiving Propofol alone for moderate sedation anesthesia (control group), the second group receiving Remimazolam alone for anesthesia, and the third group receiving a combination of Propofol and Remimazolam for anesthesia. The investigators will record anesthesia depth (DSA values of BIS), heart rate, blood pressure, oxygen saturation, and other indicators during the procedure, as well as postoperative recovery time, time to consciousness recovery, oxygen desaturation, instances of inadequate anesthesia depth, intraoperative patient movement or recall, surgeon satisfaction, patient satisfaction, readmission rate within 14 days, complications, and length of hospital stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Remimazolam
Propofol dose reduction ratio
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
RECRUITINGDose change
Change in Propofol dose ratio. (Record total dose, Duration, mg/h/kg)
Time frame: Perioperatively (during upper gastrointestinal endoscopy)
Incidence of postoperative nausea and vomiting.
Track postoperative nausea and vomiting episodes.
Time frame: After returning to the ward from the recovery room until before breakfast on the first postoperative day.
Time to open eyes after stopping Propofol or Remimazolam.
Eye open minutes after Propofol or Remimazolam stop.
Time frame: The timer starts after the anesthetic is administered.
Use of rescue medications during surgery.
Rescue drugs are used during the operation
Time frame: During surgery
Analgesic dosage in the recovery room.
Analgesic dosage in the postoperative recovery room.
Time frame: Observation period in the postoperative recovery room
Analgesic dosage in the ward.
The dosage of analgesics used in post-operative wards.
Time frame: The patients were followed up from the time they returned to the ward after surgery to the first day after surgery.
Pain Intensity (Visual Analog Scale, VAS) every 15 minutes in the recovery room for 1 hour after surgery.
Assessment of pain intensity using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst possible pain.
Time frame: Within 1 hour post-surgery.
Pain from the first injection of medication.
Assessment of pain intensity caused by the first injection of medication, measured using the Visual Analog Scale (VAS) from 0 to 10.
Time frame: During the surgery (immediately after the first injection).
Recall of surgery events.
Recall events during surgery.
Time frame: On postoperative day 1 (within 24 hours after surgery).
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