Doxapram as an additive to propofol sedation for endoscopic retrograde cholangiopancreatography: a placebo-controlled, randomized, double-blinded study

Abstract

Background Endoscopic retrograde cholangiopancreatography (ERCP) requires moderate to deep sedation, usually with propofol. Adverse effects of propofol sedation are relatively common, such as respiratory and cardiovascular depression. This study was conducted to determine if doxapram, a respiratory stimulant, could be used to reduce the incidence of respiratory depression. Methods This is a single-center, prospective randomized double-blind study performed in the endoscopy unit of Helsinki University Central Hospital. 56 patients were randomized in a 1:1 ratio to either receive doxapram as an initial 1 mg/kg bolus and an infusion of 1 mg/kg/h (group DOX) or placebo (group P) during propofol sedation for ERCP. Main outcome measures were apneic episodes and hypoxemia (SpO 2 < 90%). Mann-Whitney test for continuous variables and Fisher's exact test for discrete variables were used and mixed effects modeling to take into account repeated measurements on the same subject and comparing both changes within a group as a function of time and between the groups. Results There were no statistically significant differences in apneic episodes (p = 0.18) or hypoxemia (p = 0.53) between the groups. There was a statistically significant rise in etCO 2 levels in both groups, but the rise was smaller in group P. There was a statistically significant rise in Bispectral Index (p = 0.002) but not modified Observer's Assessment of Agitation/Sedation (p = 0.21) in group P. There were no statistically significant differences in any other measured parameters. Conclusions Doxapram was not effective in reducing respiratory depression caused by deep propofol sedation during ERCP. Further studies are warranted using different sedation protocols and dosing regimens. Clinical trial registration ClinicalTrials.gov ID NCT02171910.

Pre‐procedure intravenous lidocaine administration on propofol consumption for endoscopic retrograde cholangiopancreatography: A prospective, randomized, double‐blind study

“…For sedation, benzodiazepines, narcotics, propofol, doxapram, antihistamines, dopaminergic receptor antagonists, or combinations thereof have been tried previously. [9][10][11] Dexmedetomidine, which is an anxiolytic and sedative agent, can be used in sedation procedures without respiratory side-effects but may lead to prolonged hypotension and bradycardia. 12 The most preferred anesthetic agent in sedation is propofol.…”

Comparison of sedation efficacy and safety between dexmedetomidine and propofol during endoscopic retrograde cholangiopancreatography: A prospective, randomized, single-blinded trial

“…We hypothesized that sedation with dexmedetomidine for ERCP would reduce the incidence of hypoxemia by at least 50% when compared with sedation with propofol. Based on a previous study by Jokelainen et al [14], 60.7% of patients had hypoxemia episodes with propofol-based sedation for ERCP.…”

“…However, doubts concerning its sedation-related side effects hinder its widespread clinical application, particularly during ERCP for elderly populations and those requiring prone positions. Indeed, previous studies reported a high incidence of hypotension (4.8%-19%) and hypoxemia or apnea (3.3%-60.7%) under propofol sedation during ERCP [6,14,17,18]. Dexmedetomidine is a highly selective α-2-adrenoceptor agonist with sedative, analgesic, and anxiolytic properties.…”

Comparison of sedation efficacy and safety between dexmedetomidine and propofol during endoscopic retrograde cholangiopancreatography: A prospective, randomized, single-blinded trial

“…However, doubts concerning its sedation-related side effects hinders its widespread clinical application, particularly during ERCP for elderly populations and those requiring prone positions. Indeed, previous studies reported a high incidence of hypotension (4.8-19%) and hypoxemia or apnea (3.3-60.7%) under propofol sedation during ERCP [6, 14,17,18]. Dexmedetomidine is a highly selective α-2-adrenoceptor agonist with sedative, analgesic, and anxiolytic properties.…”