Clinical Trial: Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary: Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. However, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. Investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.
Detailed Summary:
Sponsor: Yonsei University
Current Primary Outcome:
- Overall patient satisfaction scores on a scale from 0 to 10 [ Time Frame: 24 hours after ESD ]
- Willingness to receive same method of sedation for ESD in the future as yes or no [ Time Frame: 24 hours after ESD ]
- Post-procedural pain on a VAS scale of 0 to 10 [ Time Frame: at 1 hour and 24 hours after ESD ]
- Any recall of the ESD procedure on a scale from 0 to 2 (0; no recall, 1; partial recall, 2; can recall most of procedure) [ Time Frame: 24 hours after ESD ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Yonsei University
Dates:
Date Received: July 14, 2015
Date Started: September 2014
Date Completion:
Last Updated: March 3, 2016
Last Verified: March 2016
