Safety and tolerability of esketamine in propofol based sedation for endoscopic variceal ligation with or without injection sclerotherapy: Randomized controlled trial.

OBJECTIVES

Esketamine is an S (+) enantiomer of ketamine with greater potency and similar psychomimetic effects compared to racemic ketamine. We aimed to explore the safety of esketamine in different doses as an adjuvant to propofol in patients undergoing endoscopic variceal ligation (EVL) with or without injection sclerotherapy.

METHODS

One hundred patients were randomized to receive sedation with propofol 1.5 mg/kg in combination with sufentanil 0.1 μg/kg (group S), esketamine 0.2 mg/kg (group E0.2), esketamine 0.3 mg/kg (group E0.3), or esketamine 0.4 mg/kg (group E0.4) for EVL (n = 25 each). Hemodynamic and respiratory parameters were recorded during the procedure. The primary outcome was the incidence of hypotension; secondary outcomes included the incidence of desaturation, positive and negative syndrome scale (PANSS) after the procedure, pain score after the procedure, and secretion volume.

RESULTS

The incidence of hypotension was significantly lower in groups E0.2 (36%), E0.3 (20%), and E0.4 (24%) than in group S (72%). The incidence of SpO  ≤94% was significantly lower in group E0.4 (4%) than in group S (32%). No significant intergroup difference was found in the PANSS assessment.

CONCLUSIONS

Combining 0.4 mg/kg esketamine with propofol sedation was optimal to facilitate EVL with stable hemodynamic status and better respiratory function during the procedure, without significant psychomimetic side-effects.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (Trial ID: ChiCTR2100047033, http://www.chictr.org.cn/showproj.aspx?proj=127518).