Comparison of Sedatives for the Reduction of Shoulder Dislocation Based on Bispectral Index System in Emergency Department: A Randomized, Three-Group, Double-Blinded Clinical Trial

Abstract Background and Objective: Procedural sedation and analgesia (PSA) includes the administration of sedative/dissociative medications with or without the concomitant delivery of analgesic agents. The bispectral index system (BIS) is a modern technology for neurophysiological monitoring that continuously analyzes the patient’s electroencephalogram curve during sedation to assess the level of consciousness. This study aimed to compare various PSA protocols, including propofol/fentanyl, propofol/ketamine, and ketamine, based on the BIS and other critical items in adults with anterior shoulder dislocation (ASD) in the emergency department. Materials and Methods: This randomized three-group double-blinded clinical trial was conducted on 150 patients with ASD in Besat General Hospital in Tehran, Iran. The sample size was determined at 50 individuals in each group receiving propofol/fentanyl (group A), propofol/ketamine (ketofol; group B), and ketamine (group C). Before PSA, the sensor of the BIS monitor was attached to the patient, and several items were compared, including the side effects and duration of sedation, as well as BIS values before and 1-5 min after PSA. Results: Visual analogue scale scores before and after the intervention were obtained at 8.1±0.69 and 2.08±0.7, respectively. The BIS values at the 1st, 2nd, 3rd, 4th, and 5th min after PSA were not different in the three groups. The comparison between the three groups regarding the patients’ satisfaction showed that there was a significant difference between them (P=0.02), which was higher in the ketofol group. Conclusion: The investigation of PSA using propofol/ketamine, ketamine, and propofol/fentanyl showed similar frequencies of BIS values and adverse respiratory events. The use of propofol/fentanyl was associated with a slightly higher incidence of hypotension. Moreover, the frequency of patient satisfaction was higher among the subjects in group B, compared to those in the other groups. Keywords: Bispectral index system, Fentanyl, Ketamine, Procedural sedation and analgesia, Propofo