Comparing Sedation Regimens Propofol-Remifentanil Versus Propofol-Ketamine for Percutaneous Transhepatic Biliary Drainage Procedures Assessing Recovery Time and Procedure Quality

What this Trial Is About

Researchers are evaluating two sedation and pain relief methods used during percutaneous transhepatic biliary drainage PTBD procedures in adults. This study compares propofol combined with remifentanil versus propofol combined with ketamine to determine which regimen offers better recovery time and procedure quality, especially in older and fragile patients who often have biliary obstruction, malignancy, or cholangitis. The study is a prospective, randomized, single-center trial designed to improve sedation strategies for these high-risk groups. Participants will be randomly assigned to one of two groups one receiving intravenous propofol with a continuous remifentanil infusion adjusted during the procedure, and the other receiving intravenous propofol with ketamine boluses given as needed. Both sedation methods aim to maintain a targeted sedation level, monitored with standard vital signs and sedation scores throughout the procedure. Supplemental oxygen is provided via nasal cannula, and sedation depth is checked every five minutes. Recovery is assessed using the Modified Aldrete Score at two-minute intervals until patients reach adequate recovery. Participants will be closely monitored during and after the procedure for recovery time, pain levels, sedation depth, and any sedation-related side effects like low blood pressure or breathing difficulties. Patient and operator satisfaction, drug use, and procedural tolerance will also be recorded. Hemodynamic stability and adverse events are tracked from baseline through recovery, with outcome measures focusing on safety, comfort, and quality of sedation. The total participation includes the procedure and recovery period, with assessments up to 30 minutes post-procedure.

Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery