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Randomized Controlled Trial
. 2023 Dec 1;6(12):e2347886.
doi: 10.1001/jamanetworkopen.2023.47886.

Effect of Esketamine Added to Propofol Sedation on Desaturation and Hypotension in Bidirectional Endoscopy: A Randomized Clinical Trial

Nan Song  1   2 , Yi Yang  3 , Zhong Zheng  4 , Wen-Cheng Shi  4 , Ai-Ping Tan  3 , Xi-Sheng Shan  1   2 , Hong Liu  5 , Lingzhong Meng  6 , Ke Peng  1   2 , Fu-Hai Ji  1   2
Affiliations
Randomized Controlled Trial

Effect of Esketamine Added to Propofol Sedation on Desaturation and Hypotension in Bidirectional Endoscopy: A Randomized Clinical Trial

Nan Song et al. JAMA Netw Open. .

Abstract

Importance: Propofol sedation is widely used for endoscopic procedures, but it poses risks of hemodynamic and respiratory depression. The addition of esketamine as an adjuvant may reduce propofol requirements and associated adverse events.

Objective: To evaluate the effects of low-dose esketamine added to propofol-based sedation on desaturation and hypotension during same-visit bidirectional endoscopy.

Design, setting, and participants: This multicenter, double-blind, placebo-controlled randomized clinical trial assessed patients from 3 teaching hospitals in China who were scheduled for same-visit bidirectional endoscopy between February 8 and November 30, 2022, and randomly assigned to receive esketamine or normal saline (placebo).

Interventions: After induction of sedation with 0.1 μg/kg of sufentanil and 0.5 mg/kg of propofol, patients in the esketamine group received 0.15 mg/kg of intravenous esketamine, whereas patients in the placebo group received an equivalent volume of saline. Sedation was achieved through propofol titration.

Main outcomes and measures: The primary outcome was the composite of desaturation and hypotension during the procedures. Secondary outcomes included desaturation, hypotension, propofol requirements, postprocedure pain and fatigue, nausea or vomiting, dizziness or headache, hallucination or nightmare, endoscopist satisfaction, and patient satisfaction.

Results: Among the 663 initially enrolled patients, 660 completed the study (median [IQR] age, 48 [36-57] years; 355 [53.8%] female), with 331 randomized to the esketamine group and 329 to the placebo group. The administration of esketamine compared with placebo significantly reduced the incidence of the composite outcome of desaturation and hypotension (8.2% vs 21.0%; difference, -12.8 percentage points; odds ratio [OR], 0.34; 95% CI, 0.21-0.54; P < .001). Additionally, esketamine led to significantly lower incidences of desaturation (OR, 0.36; 95% CI, 0.18-0.72; false discovery rate q = .01) and hypotension (OR, 0.33; 95% CI, 0.18-0.60; q < .001) and reduced propofol requirements (difference, -58.9 mg; 95% CI, -65.7 to -52.2 mg; q < .001), without significant effects on other secondary outcomes.

Conclusions and relevance: In this randomized clinical trial of patients undergoing same-visit bidirectional endoscopy, the administration of low-dose esketamine resulted in an approximately 61% reduction in the incidence of desaturation and hypotension, accompanied by decreased propofol requirements. These findings support the use of esketamine as an adjuvant to propofol-based sedation in endoscopic procedures.

Trial registration: Chinese Clinical Trial Registry Identifier: ChiCTR2200055938.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Ji reported receiving lecture fees from Yichang Humanwell outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Flow Diagram
Figure 2.
Figure 2.. Subgroup Analyses of the Composite Outcome of Desaturation and Hypotension
BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); OR, odds ratio.
See this image and copyright information in PMC

References

    1. Lucendo AJ, González-Huix F, Tenias JM, et al. ; Spanish Society of Digestive Diseases, Spanish Society of Digestive Endoscopy, and Spanish Association of Gastroenterology . Gastrointestinal endoscopy sedation and monitoring practices in Spain: a nationwide survey in the year 2014. Endoscopy. 2015;47(4):383-390. doi: 10.1055/s-0034-1391672 - DOI - PubMed
    1. Jung Y, Kim JW, Im JP, Cho YK, Lee TH, Jang JY. Safety of gastrointestinal endoscopy in Korea: a nationwide survey and population-based study. J Korean Med Sci. 2022;37(4):e24. doi: 10.3346/jkms.2022.37.e24 - DOI - PMC - PubMed
    1. Xin L, Gao Y, Cheng Z, et al. Utilization and quality assessment of digestive endoscopy in China: results from 5-year consecutive nationwide surveys. Chin Med J (Engl). 2022;135(16):2003-2010. doi: 10.1097/CM9.0000000000002366 - DOI - PMC - PubMed
    1. Gu WJ, Wang HT, Huang J, et al. High flow nasal oxygen versus conventional oxygen therapy in gastrointestinal endoscopy with conscious sedation: systematic review and meta-analysis with trial sequential analysis. Dig Endosc. 2022;34(6):1136-1146. doi: 10.1111/den.14315 - DOI - PubMed
    1. Dossa F, Megetto O, Yakubu M, Zhang DDQ, Baxter NN. Sedation practices for routine gastrointestinal endoscopy: a systematic review of recommendations. BMC Gastroenterol. 2021;21(1):22. doi: 10.1186/s12876-020-01561-z - DOI - PMC - PubMed

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