Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Location status: Recruiting
Location contact
Chen-Hsiu Chen, Ph.D
CONTACT
886-7-342-2121 ext. 74105
Yuan-Yi Chia, Bachelor
CONTACT
886-7-342-2121 ext. 74105
NCT Number: NCT06777758
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.
Interested in participating?
Request Info20 year–80 year
All sexes
Interventional
Phase 4
Kaohsiung City, 81362, Taiwan
Location status: Recruiting
Chen-Hsiu Chen, Ph.D
CONTACT
886-7-342-2121 ext. 74105
Yuan-Yi Chia, Bachelor
CONTACT
886-7-342-2121 ext. 74105
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Remimazolam
Propofol dose reduction ratio
Time frame: Perioperatively (during upper gastrointestinal endoscopy)
Change in Propofol dose ratio. (Record total dose, Duration, mg/h/kg)
Time frame: After returning to the ward from the recovery room until before breakfast on the first postoperative day.
Track postoperative nausea and vomiting episodes.
Time frame: The timer starts after the anesthetic is administered.
Eye open minutes after Propofol or Remimazolam stop.
Time frame: During surgery
Rescue drugs are used during the operation
Time frame: Observation period in the postoperative recovery room
Analgesic dosage in the postoperative recovery room.
Time frame: The patients were followed up from the time they returned to the ward after surgery to the first day after surgery.
The dosage of analgesics used in post-operative wards.
Time frame: Within 1 hour post-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: During the surgery (immediately after the first injection).
Assessment of pain intensity caused by the first injection of medication, measured using the Visual Analog Scale (VAS) from 0 to 10.
Time frame: On postoperative day 1 (within 24 hours after surgery).
Recall events during surgery.
Contact information is provided by the study sponsor or research team.
Chen-Hsiu Chen, Ph.D
CONTACT
886-7-342-2121 ext. 74105
Yuan-Yi Chia, M.D
CONTACT
886-7-342-2121 ext. 74105
Kaohsiung Veterans General Hospital.
Other
The Comparison of Remimazolam or Propofol Used Alone Versus in Combination for Moderate Sedation During Endoscopic Examination and Treatment.
Acronym: Remimazolam
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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