Effects of ciprofol versus propofol sedation on hypoxaemia and hypotension in elderly patients undergoing bidirectional endoscopy: protocol for a randomized controlled trial.

BACKGROUND

In elderly patients undergoing gastrointestinal endoscopy under sedation, respiratory and haemodynamic instability remains a significant concern. Compared with the commonly used propofol, ciprofol may offer improved cardiorespiratory stability. This study aims to evaluate the effects of ciprofol versus propofol on the incidence of hypoxaemia and hypotension in elderly patients undergoing bidirectional gastrointestinal endoscopy under sedation.

METHODS

This is a single-center, prospective, randomized, double-blind, parallel-controlled clinical trial conducted at a tertiary academic hospital. A total of 184 patients aged ≥65 years undergoing elective bidirectional gastrointestinal endoscopy under sedation will be randomly assigned in a 1:1 ratio to receive either ciprofol or propofol using block randomization stratified by hypertension status, with block sizes of 2 and 4. The primary outcome is the composite incidence of hypoxaemia (SpO₂ < 93%, for >10 s) and hypotension (systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg, or a ≥ 20% decrease from baseline) during sedation. Secondary outcomes will include the individual incidences of hypoxaemia and hypotension, airway interventions, use of vasoactive drugs, sedation and recovery times, total sedative dose, and patient and endoscopist satisfaction. Safety outcomes will include nausea or vomiting, dizziness, headache, respiratory depression, bradycardia and arrhythmias.

DISCUSSION: This study aims to provide high-quality evidence regarding whether ciprofol improves respiratory and haemodynamic safety compared with propofol in elderly patients undergoing bidirectional gastrointestinal endoscopy.

CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=307374, ChiCTR2600117418.