Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial Design

Abstract

Background: Same-day esophagogastroduodenoscopy and colonoscopy procedures under sedation have been increasingly performed. This study aims to assess the effects of esketamine combined with ciprofol (a novel anesthetic/sedative agent) or propofol on respiratory and hemodynamic adverse events in patients undergoing same-day bidirectional endoscopy.Methods: This is a prospective, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. A total of 180 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomized, in a 1:1:1:1 ratio, to receive 1 of 4 sedation regimens: 1) ciprofol and esketamine, 2) propofol and esketamine, 3) ciprofol and normal saline placebo, or 4) propofol and normal saline placebo. The primary outcome is a composite of desaturation [peripheral oxygen saturation (SpO2) < 95%] and hypotension [mean blood pressure (MBP) < 65 mmHg or decrease in MBP ≥20% of baseline] during the sedation and in the recovery room. Secondary outcomes include episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in MBP ≥30% of baseline), bradycardia, postoperative nausea and vomiting, dizziness or headache, hallucination or nightmare, injection pain, pain scores and fatigue scores, endoscopist satisfaction, and patient satisfaction. Data will be analyzed on the modified intention-to-treat basis.Discussion: We hypothesize that esketamine as an adjuvant to ciprofol or propofol sedation would improve cardiorespiratory stability. In addition, the potential interactions between interventions will be explored using the factorial design. The results of this trial will provide evidence for daily practice of sedation regimens for same-day bidirectional endoscopy.Clinical Trial Registration: Chinese Clinical Trials Registry, Identifier ChiCTR2100052523.

Efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil during fiberoptic bronchoscopy: A prospective, randomized, double-blind, non-inferiority trial

“…We only recruited patients with ASA I-II and those who had a procedure time <30 min (eg, endobronchial inspection, bronchoscopic biopsy, and bronchoalveolar lavage). However, with the development of respiratory endoscopy technology, more complex endoscopic therapy is required under anesthesia, when there is no contraindication according to guidelines ( Wahidi et al, 2011 ; Strohleit et al, 2021 ; Long et al, 2022 ). A previous study reported that ciprofol produces similar levels of sedation compared with propofol in the intensive care unit setting to achieve required sedation times of 6–24 h ( Liu et al, 2022 ).…”

Determining the effective dose of esketamine for mitigating pain during propofol injection by Dixon’s up-and-down method: a double-blind, prospective clinical study of drug dose response

“…Presently, esketamine is increasingly replacing ketamine in clinical practice in China, especially in the application of short-duration and same-day surgeries [ 14 , 20 , 21 , 24 ]. Our research focused on determining the effective dose of esketamine to relieve propofol injection pain, and observing the clinical effect of low-dose esketamine in reduce pain from propofol injection.…”

“…Neither HR nor MAP was significantly decreased at 1 and 3 min after propofol induction. This may be due to the weaker sympathomimetic effect of esketamine at low doses, which counteract the inhibitory effect of propofol on the cardiovascular system [ 7 , 24 ]. Before and after propofol induction, SpO 2 was stable and no respiratory depression was observed, which may be related to the respiratory stimulatory effect of low-dose esketamine, which alleviated the inhibitory effect of propofol on respiration [ 7 , 15 ].…”

The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial

“…It has been adopted in some European countries for decades and has been used in Chinese hospitals in recent years. Besides treating depression, esketamine is applied for clinical sedation and analgesia associated with same-day bidirectional endoscopy ( Long et al, 2022 ), pediatric dental surgery ( Xin et al, 2021 ) and mechanical ventilation in ICU patients ( Song et al, 2022 ) When it is used for bronchoscopy, esketamine relaxes bronchiolar muscles and inhibits bronchial constriction ( Huang et al, 2022 ).…”