Respiratory Support With Nasal High Flow Reduces Opioid Requirements During Endoscopic Retrograde Cholangiopancreatography.
Nasal high flow may reduce opioid needs during ERCP without affecting oxygenation or sedation depth, but further multi-center studies are needed.
Where it sits
this study against the rest of the glutathione (gsh) corpusSummary and findings
This open-label, single-center RCT compared nasal high flow (NHF) to low-flow oxygen (LFO) in 94 patients undergoing ERCP with dexmedetomidine-based sedation. NHF reduced opioid requirements, with a median pethidine dose of 43.75 mg versus 70.00 mg in the LFO group. No adverse events were attributed to the interventions.
Abstract
<h4>Objectives</h4>Nasal high flow (NHF) improves oxygenation, reduces the work of breathing, and stabilizes ventilation. In endoscopic retrograde cholangiopancreatography (ERCP) under dexmedetomidine-based sedation, opioids are often required but increase the risk of respiratory depression and delayed recovery. This study tested the hypothesis that NHF therapy, compared with low-flow oxygen (LFO), may reduce opioid requirements during ERCP.<h4>Methods</h4>This open-label, single-center, randomized controlled trial enrolled patients undergoing ERCP under dexmedetomidine-based sedation. Patients were randomized to NHF or LFO. Sedation used dexmedetomidine, midazolam and pethidine with a standardized protocol. The primary endpoint was total pethidine dose. Secondary endpoints included transcutaneous carbon dioxide (TcCO<sub>2</sub>), oxygenation-perfusion parameters, processed electroencephalography (EEG) parameters, sedative doses, and sedation depth.<h4>Results</h4>Enrollment ended early at a total of 94 of the planned 118 patients due to slow recruitment (NHF 47, LFO 47). Poisson regression demonstrated reduced opioid requirements with NHF (incidence rate ratio 0.77, 95% confidence interval, 0.62-0.96, <i>p</i> = 0.023). The total pethidine dose was lower in the NHF group (medians 43.75 mg vs. 70.00 mg, <i>p</i> = 0.004). The TcCO<sub>2</sub> and oxygenation-perfusion parameters were comparable between groups. EEG tests showed lower patient state index and electromyographic activity in the NHF group, indicating deeper sedation. No adverse events attributable to interventions were observed.<h4>Conclusion</h4>NHF reduced opioid requirements while maintaining oxygenation, ventilation, and sedation during ERCP. The ability of NHF to provide respiratory support, ensure adequate oxygenation, and allow monitoring of breathing makes it a promising modality during procedural sedation; however, further multi-center studies are needed.<h4>Trial registration</h4>072210047 [jRCTs].
Background
The study addresses the need to reduce opioid use during ERCP procedures, where opioids can cause respiratory depression and delayed recovery. NHF is known to improve oxygenation and stabilize ventilation, potentially reducing the need for opioids. This study explores whether NHF can effectively reduce opioid requirements compared to LFO in a clinical setting.
Methods
This was an open-label, single-center randomized controlled trial involving patients undergoing ERCP under dexmedetomidine-based sedation. A total of 94 patients were randomized to receive either NHF or LFO. The primary endpoint was the total dose of pethidine administered. Secondary endpoints included transcutaneous carbon dioxide levels, oxygenation-perfusion parameters, processed EEG parameters, sedative doses, and sedation depth.
Results
The primary endpoint showed a statistically significant reduction in opioid requirements with NHF, with a median pethidine dose of 43.75 mg compared to 70.00 mg in the LFO group (p=0.004). The incidence rate ratio for opioid requirement was 0.77 (95% CI, 0.62-0.96, p=0.023). Secondary outcomes such as TcCO2 and oxygenation-perfusion parameters were similar between groups. EEG results indicated deeper sedation in the NHF group. No adverse events were linked to the interventions.
Interpretation
The findings suggest that NHF can reduce opioid requirements during ERCP without compromising oxygenation or ventilation. While the reduction in opioid use is statistically significant, the clinical significance may vary depending on individual patient contexts. The study's limitations, including its single-center design and early termination, suggest that further research is needed to confirm these findings in broader settings.
Key findings
- Poisson regression incidence rate ratio 0.77, 95% CI 0.62-0.96, p=0.023.
- Median pethidine dose 43.75 mg NHF vs 70.00 mg LFO, p=0.004.
- Enrollment ended early at 94 of planned 118 patients.
- TcCO2 and oxygenation-perfusion parameters were comparable between groups.
- EEG tests indicated deeper sedation in NHF group.
Limitations
- Single-center study
- Open-label design
- Early termination due to slow recruitment
- Limited generalizability