Propofol sedation during gastrointestinal endoscopy arouses euphoria in a large subset of patients.
Thorsten Brechmann, Christoph Maier, Miriam Kaisler...
https://pubmed.ncbi.nlm.nih.gov/29881609/Actively Recruiting
Led by Zhangjie Yu · Updated on 2024-12-06
305
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are investigating how often remimazolam, a short-acting sedative, causes feelings of euphoria in patients undergoing gastrointestinal endoscopy, including gastroscopy and colonoscopy. This study explores factors related to this euphoria and aims to improve sedation practices to help patients feel more comfortable and satisfied during these procedures. The study is observational and focuses on sedation effects and patient experience. Participants receive sedation according to standard guidelines, starting with sufentanil and lidocaine gel for oral preparation, followed by remimazolam administered intravenously. The initial dose of remimazolam is 0.2-0.3 mgkg, with additional 2.5 mg doses given as needed to maintain sedation. The sedative is chosen for its quick onset and recovery, with minimal effects on breathing and heart function. Data will be collected on patient demographics, euphoria scores before sedation and two hours after the procedure, safety indicators, and satisfaction. During the study, patients will be monitored from before sedation until two hours after full recovery. Researchers will assess euphoria using a specific scale and record safety information and patient satisfaction levels. The study lasts throughout the procedure and recovery period, aiming to understand how remimazolam affects patient comfort and cooperation, with the goal of optimizing sedation protocols.
CONDITIONS
Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors
Z
Zhangjie Yu, M.Sc.
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Zhangjie Yu
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 - Up to 30 minutes for the procedure
Participants receive sedation with remimazolam during routine painless gastrointestinal endoscopy procedures. Sedation is administered according to standard clinical guidelines including pre-procedural medications and intravenous remimazolam to maintain adequate sedation.
1 procedure visit (in-person)
Duration - 2 hours post-procedure
Participants are observed for euphoria and related factors from immediately before sedation until two hours after the procedure upon full recovery.
Assessments at 2 time points (pre-sedation and 2 hours post-procedure)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Lead Sponsor