Clinical Trials Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Mar 26, 2022; 10(9): 2773-2782
Published online Mar 26, 2022. doi: 10.12998/wjcc.v10.i9.2773
Determination of the ED95 of intranasal sufentanil combined with intranasal dexmedetomidine for moderate sedation during endoscopic ultrasonography
Yi Zou, Na Li, Liu-Jia-Zi Shao, Fu-Kun Liu, Fu-Shan Xue, Xing Tao
Yi Zou, Na Li, Liu-Jia-Zi Shao, Fu-Kun Liu, Fu-Shan Xue, Xing Tao, Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
Author contributions: Zou Y and Li N contributed equally to this work as first authors; Zou Y, Xue FS, Liu FK and Tao X designed the research study; Zou Y, Li N, Shao LJZ, and Liu FK performed the research; Zou Y, Li N, Xue FS, and Tao X analyzed the data and wrote the manuscript; all authors have read and approve the final manuscript.
Supported by the Research Foundation of Beijing Friendship Hospital, Capital Medical University, No. yyqdkt2018-16; the Beijing Municipal Administration of Hospitals’ Youth Program, No. QML20190101; and the Scientific Research Common Program of Beijing Municipal Commission of Education, No. KM202010025021.
Institutional review board statement: The study was reviewed and approved by the Bioethics Committee of Beijing Friendship Hospital, Capital Medical University (Ethics Committee number: 2018-P2-164-02).
Clinical trial registration statement: The study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800019273).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare no potential conflicting interests related to this paper.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Xing Tao, MD, Doctor, Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong-An Road, Xi-Cheng District, Beijing 100050, China. taoxing43@sina.com
Received: October 19, 2021
Peer-review started: October 19, 2021
First decision: December 10, 2021
Revised: December 24, 2021
Accepted: January 29, 2022
Article in press: January 29, 2022
Published online: March 26, 2022
Processing time: 154 Days and 8.5 Hours
Abstract
BACKGROUND

Sedation during endoscopic ultrasonography (EUS) poses many challenges and moderate-to-deep sedation are often required. The conventional method to preform moderate-to-deep sedation is generally intravenous benzodiazepine alone or in combination with opioids. However, this combination has some limitations. Intranasal medication delivery may be an alternative to this sedation regimen.

AIM

To determine, by continual reassessment method (CRM), the minimal effective dose of intranasal sufentanil (SUF) when combined with intranasal dexmedetomidine (DEX) for moderate sedation of EUS in at least 95% of patients (ED95).

METHODS

Thirty patients aged 18-65 and scheduled for EUS were recruited in this study. Subjects received intranasal DEX and SUF for sedation. The dose of DEX (1 μg/kg) was fixed, while the dose of SUF was assigned sequentially to the subjects using CRM to determine ED95. The sedation status was assessed by modified observer’s assessment of alertness/sedation (MOAA/S) score. The adverse events and the satisfaction scores of patients and endoscopists were recorded.

RESULTS

The ED95 was intranasal 0.3 μg/kg SUF when combined with intranasal 1 μg/kg DEX, with an estimated probability of successful moderate sedation for EUS of 94.9% (95% confidence interval: 88.1%-98.9%). When combined with intranasal 1 μg/kg DEX, probabilities of successful moderate sedation at each dose level of intranasal SUF were as follows: 0 μg/kg SUF, 52.8%; 0.1 μg/kg SUF, 75.4%; 0.2 μg/kg SUF, 89.9%; 0.3 μg/kg SUF, 94.9%; 0.4 μg/kg SUF, 98.0%; 0.5 μg/kg SUF, 99.0%.

CONCLUSION

The ED95 needed for moderate sedation for EUS is intranasal 0.3 μg/kg SUF when combined with intranasal 1 μg/kg DEX, based on CRM.

Keywords: Moderate sedation; Intranasal administration; Dexmedetomidine; Sufentanil; Continual reassessment method; Endoscopic ultrasonography

Core Tip: The conventional method to preform moderate-to-deep sedation is generally intravenous benzodiazepine alone or in combination with opioids. There are many limitations to this method, including an inability for patients to tolerate it due to the possible longevity of endoscopic ultrasonography (EUS) procedures. This study aimed to provide an effective method for moderate-to-deep sedation in EUS via an intranasal approach. We believe that our study makes a significant contribution to the literature because it provides an alternative to intravenous administration by administering intranasal 1 μg/kg DEX in combination with 0.3 μg/kg sufentanil to patients scheduled for EUS.