Clinical Research Directory

Safety of Sedation During Interventional Endoscopy

Sedation is routinely used during interventional endoscopic procedures to improve patient comfort and optimize procedural conditions. Non-anaesthesiologist-administered propofol sedation (NAPS) has been demonstrated to be safe and effective for many endoscopic procedures, including complex interventions such as endoscopic retrograde cholangiopancreatography (ERCP). However, evidence supporting its use during technically demanding or prolonged procedures and in patients with severe comorbidities (ASA class ≥ III) remains limited. At our institution, interventional endoscopic procedures have been routinely performed for many years using standardized NAPS protocols, including in higher-risk patients, with comprehensive staff training, continuous patient monitoring, supplemental oxygen administration, and immediate access to an emergency response team. This non-interventional observational study will prospectively collect data on sedation practices, procedural characteristics, and sedation-related outcomes during routine interventional endoscopy without altering standard clinical care. The primary objective is to evaluate the safety of NAPS across a broad spectrum of interventional endoscopic procedures and patient risk profiles, thereby providing real-world evidence to inform future clinical practice and guideline recommendations.

Tolerability of Remimazolam Versus Midazolam in EUS

This study will observe and compare patient experience during outpatient diagnostic endoscopic ultrasound (EUS) when moderate sedation is provided with either remimazolam plus fentanyl or midazolam plus fentanyl, according to routine clinical practice. Both sedation approaches are currently used in standard care. The choice of sedative will be made by the treating physician as part of usual practice and not assigned by the study. The purpose of the study is to evaluate how patients tolerate the procedure with each sedation strategy, focusing on comfort, recovery, and overall procedural experience. After the procedure, participants will be asked to complete questionnaires about their experience at 1 hour and 24 hours after EUS. The study will also collect information on sedation effectiveness, operator satisfaction, recovery time, adverse events, and costs. This is a prospective observational single-center study involving adult outpatients undergoing diagnostic EUS. Information collected during routine care, including vital signs, recovery measures, and procedural data, will be analyzed to compare outcomes between the two sedation approaches.

Comparison Between Two Drugs in Sedation of Upper GI Endoscopy

The goal of this clinical trial is to compare time of sedation between two drugs administered to patients undergoing upper gastrointestinal endoscopy Primary outcome : Time of sedation : is the time to reach sedation score of 5 according to modified Ramsay sedation score starting from the time of injecting bolts dose of study drugs Secondary outcome : * Recovery time :is the time to reach score 2 of modified Ramsay sedation score starting from injecting bolus dose of study drugs . * Hemodynamics (MAP,HR) \& oxygen saturation * Drug side effects (nausea,vomitting,agitation) * Endoscopist satisfaction