BIS-Guided Propofol vs Remifentanil for Gastroscopy: Effects on Procedure Start Time and Recovery
Status:
NOT_YET_RECRUITING
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
This study compares two different sedation methods used during gastroscopy (a procedure to examine the upper digestive tract with a camera). Patients will be randomly assigned to receive either propofol-based sedation or remifentanil-based sedation, both combined with a standard premedication drug called midazolam.
During the procedure, the depth of sedation will be monitored using a device called a Bispectral Index (BIS) monitor, which measures brain activity to ensure patients receive the right amount of sedation-not too little and not too much. The sedation will be adjusted to keep patients comfortable but able to respond to simple commands.
The main goal of this study is to compare how quickly patients wake up after the procedure ends with each sedation method. The researchers will also measure:
* How quickly the procedure can begin after sedation starts
* How much sedation medication is needed
* How long the gastroscopy takes
* When patients are ready to go home
* Whether the BIS monitor readings match with clinical assessments of sedation
* Side effects such as low blood pressure, slow heart rate, or nausea
* How satisfied the endoscopist (the doctor performing the gastroscopy) is with the sedation quality
This research will help doctors understand which sedation approach provides better procedural efficiency, faster recovery, and fewer side effects for patients undergoing gastroscopy. Both propofol and remifentanil are already widely used and approved medications for sedation, and both will be given according to standard medical practice under careful monitoring.
Participants will be adults scheduled for routine diagnostic gastroscopy at Fatih Sultan Mehmet Training and Research Hospital. The study will enroll 80 patients total, with 40 patients in each sedation group.
Phase:
NA
Details
Lead Sponsor:
Fatih Sultan Mehmet Training and Research Hospital