Extended monitoring of the sedated patient: bispectral index, Narcotrend and automated responsiveness monitor.
Till Wehrmann
https://pubmed.ncbi.nlm.nih.gov/20407252/Actively Recruiting
Led by Kaohsiung Veterans General Hospital. · Updated on 2025-05-08
90
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effectiveness and safety of Remimazolam, used alone or combined with Propofol, for moderate sedation anesthesia during endoscopic procedures such as upper gastrointestinal endoscopy. The study aims to determine if combining these drugs improves anesthesia quality and recovery outcomes compared to using each drug alone. This is a prospective, randomized study conducted at a single center, focusing on sedation during endoscopic examinations and treatments. Participants will be randomly assigned to one of three groups Propofol alone, Remimazolam alone, or a combination of both drugs for sedation during the procedure. Throughout the endoscopic examination, various measures will be recorded including anesthesia depth, heart rate, blood pressure, and oxygen levels. Researchers will also monitor recovery time, consciousness return, episodes of oxygen desaturation, patient movement, recall of the procedure, satisfaction of both patients and surgeons, readmission rates within 14 days, complications, and hospital stay length. During the study, participants will undergo routine upper gastrointestinal endoscopy with their assigned sedation method. Assessments will include monitoring vital signs, anesthesia depth, and collecting data on postoperative nausea, vomiting, pain intensity, and analgesic use. Pain will be evaluated using a visual scale every 15 minutes for one hour after surgery. The main outcome measured is the dose changes of sedative drugs during the procedure. Safety and recovery will be closely observed, with follow-up until the first day after surgery.
CONDITIONS
Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments
Y
Yuan-Yi Chia, M.D
C
Chen-Hsiu Chen, Ph.D
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Kaohsiung Veterans General Hospital.
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the endoscopic procedure
Participants receive moderate sedation anesthesia using Remimazolam, Propofol, or their combination during upper gastrointestinal endoscopic examinations or treatments.
1 visit (in-person procedure day)
Duration - Up to 1 day post-procedure
Participants are monitored after sedation for recovery time, complications, pain intensity, nausea, and recall of surgery events.
1 to 2 visits including recovery room observation and ward follow-up
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Lead Sponsor