Propofol-fentanyl versus propofol-dexmedetomidine in outpatient procedures sedation: a triple-blind, randomized controlled clinical trial

Abstract

Introduction

The choice of anesthetic agents plays a crucial role in procedural success. This study aimed to compare the effects of propofol-fentanyl and propofol-dexmedetomidine combinations, focusing on patient and surgeon perspectives in outpatient procedures.

Methods

A randomized, controlled, triple-blind clinical trial including 128 adult patients undergoing elective outpatient surgical procedures with sedation and local anesthesia. Patients were randomized to receive either propofol-fentanyl (PF, n = 64) or propofol-dexmedetomidine (PDex, n = 64). Primary outcomes were patient satisfaction, assessed using the ISAS-Br score, and the adequacy of sedation, evaluated by the surgeon and measured by a Numerical Rating Scale (NRS) for movement. Respiratory and hemodynamic changes, as well as awakening from anesthesia, adverse events during recovery, and time to hospital discharge were compared.

Results

No difference between patient satisfaction scores (median ISAS-Br [IQR]: PF 2.64 [2.45‒3.00] vs. PDex 3.00 [2.45‒3.00], p = 0.252). The PF group had a significantly lower movement score (median NRS [IQR]: 0.5 [0.00‒2.25] vs. 2.0 [0.00‒5.00], p = 0.006). The incidence of intraoperative events related to respiration and hemodynamics, as postoperative pain and postoperative nausea/vomiting were similar. A higher proportion of patients sedated with PF awoke in the operating room (75% vs. 35.9%, p < 0.001), and 98.4% of the PF group vs. 92.2% of the PDex group were ready for hospital discharge in less than thirty minutes, p = 0.208.

Conclusion

Single doses of fentanyl or dexmedetomidine combined with propofol resulted in equivalent patient satisfaction, safety, and discharge times. The propofol-fentanyl combination demonstrated superior sedation adequacy from the surgeon’s perspective and facilitated a faster emergence from anesthesia.