Sufentanil target controlled infusion (TCI) versus remifentanil TCI for monitored anaesthesia care for patients with severe tracheal stenosis undergoing fiberoptic bronchoscopy: protocol for a prospective, randomised, controlled study.

INTRODUCTION

The use of monitored anaesthesia care (MAC) is necessary and ubiquitous for fiberoptic bronchoscopy. Anaesthetic management of patients with severe tracheal stenosis has always been a challenge. The efficacy and safety of the MAC with sufentanil target controlled infusion (TCI) and remifentanil TCI in patients with severe tracheal stenosis are still unknown.

METHODS ANALYSIS

This study is a prospective, investigator-initiated, two-arm, randomised control trial to compare the efficacy and safety of sufentanil TCI with remifentanil TCI in patients with severe tracheal stenosis undergoing fiberoptic bronchoscopy. 270 patients will be randomly assigned to the sufentanil TCI group or remifentanil TCI group, with a 1:1 ratio in two groups. The primary outcome is the incidence of hypoxaemia (an oxygen saturation of <90%). The secondary outcome investigates the severity of hypoxaemia, cough severity, haemodynamic variables, sedation scores and satisfaction scores.

ETHICS AND DISSEMINATION

The study has been approved by the Medical Ethics Committee of Shanghai Pulmonary Hospital (approval No. K19-122). The results will be submitted for publication in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ChiCTR2100043380.