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Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial

BACKGROUND: Oxygen-desaturation episodes, blood pressure drops, and involuntary body movement are common problems that occur in propofol-based sedation in the procedure of painless gastrointestinal (GI) endoscopy. As a widely used analgesic adjuvant, intravenous lidocaine can reduce the consumption...

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Autores principales: Qi, Xiu-Ru, Sun, Jing-Yi, An, Li-Xin, Zhang, Ke, Xue, Fu-Shan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9509543/
https://www.ncbi.nlm.nih.gov/pubmed/36153625
http://dx.doi.org/10.1186/s13063-022-06719-6
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author Qi, Xiu-Ru
Sun, Jing-Yi
An, Li-Xin
Zhang, Ke
Xue, Fu-Shan
author_facet Qi, Xiu-Ru
Sun, Jing-Yi
An, Li-Xin
Zhang, Ke
Xue, Fu-Shan
author_sort Qi, Xiu-Ru
collection PubMed
description BACKGROUND: Oxygen-desaturation episodes, blood pressure drops, and involuntary body movement are common problems that occur in propofol-based sedation in the procedure of painless gastrointestinal (GI) endoscopy. As a widely used analgesic adjuvant, intravenous lidocaine can reduce the consumption of propofol during ERCP or colonoscopy. However, it is still unknown how lidocaine affects the incidence of oxygen-desaturation episodes and cardiovascular events, and involuntary movement during painless GI endoscopy. Therefore, we aimed to assess the effectiveness and safety of intravenous lidocaine in propofol-based sedation for GI endoscopy. METHODS: We will conduct a single-center, prospective, randomized, double-blind, saline-controlled trial. A total number of 300 patients undergoing painless GI procedures will be enrolled and randomly divided into the lidocaine group (Group L) and the control group (Group C). After midazolam and sufentanil intravenous injection, a bolus of 1.5 mg/kg lidocaine was immediately injected and followed by a continuous infusion of 4 mg/kg/h in the lidocaine group, whereas the same volumes of saline solution in the control group. Then, propofol was titrated to produce unconsciousness during the procedure. The primary outcome will be the incidence of oxygen-desaturation episodes. Secondary outcomes will be the incidence of involuntary body movement, discomfort symptoms, propofol consumption, endoscopist, and patient satisfaction. DISCUSSION: Propofol-based deep sedation without intubation is widely used in painless GI endoscopy. However, adverse events such as hypoxemia often occur clinically. We expect to assess the effect of lidocaine on reducing the incidence of oxygen-desaturation episodes, cardiovascular events, and involuntary body movement. We believe that the results of this trial will provide an effective and safe method for painless GI endoscopy. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100053818. Registered on 30 November 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06719-6.
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spelling pubmed-95095432022-09-26 Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial Qi, Xiu-Ru Sun, Jing-Yi An, Li-Xin Zhang, Ke Xue, Fu-Shan Trials Study Protocol BACKGROUND: Oxygen-desaturation episodes, blood pressure drops, and involuntary body movement are common problems that occur in propofol-based sedation in the procedure of painless gastrointestinal (GI) endoscopy. As a widely used analgesic adjuvant, intravenous lidocaine can reduce the consumption of propofol during ERCP or colonoscopy. However, it is still unknown how lidocaine affects the incidence of oxygen-desaturation episodes and cardiovascular events, and involuntary movement during painless GI endoscopy. Therefore, we aimed to assess the effectiveness and safety of intravenous lidocaine in propofol-based sedation for GI endoscopy. METHODS: We will conduct a single-center, prospective, randomized, double-blind, saline-controlled trial. A total number of 300 patients undergoing painless GI procedures will be enrolled and randomly divided into the lidocaine group (Group L) and the control group (Group C). After midazolam and sufentanil intravenous injection, a bolus of 1.5 mg/kg lidocaine was immediately injected and followed by a continuous infusion of 4 mg/kg/h in the lidocaine group, whereas the same volumes of saline solution in the control group. Then, propofol was titrated to produce unconsciousness during the procedure. The primary outcome will be the incidence of oxygen-desaturation episodes. Secondary outcomes will be the incidence of involuntary body movement, discomfort symptoms, propofol consumption, endoscopist, and patient satisfaction. DISCUSSION: Propofol-based deep sedation without intubation is widely used in painless GI endoscopy. However, adverse events such as hypoxemia often occur clinically. We expect to assess the effect of lidocaine on reducing the incidence of oxygen-desaturation episodes, cardiovascular events, and involuntary body movement. We believe that the results of this trial will provide an effective and safe method for painless GI endoscopy. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100053818. Registered on 30 November 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06719-6. BioMed Central 2022-09-24 /pmc/articles/PMC9509543/ /pubmed/36153625 http://dx.doi.org/10.1186/s13063-022-06719-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Qi, Xiu-Ru
Sun, Jing-Yi
An, Li-Xin
Zhang, Ke
Xue, Fu-Shan
Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial
title Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial
title_full Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial
title_fullStr Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial
title_full_unstemmed Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial
title_short Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial
title_sort effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9509543/
https://www.ncbi.nlm.nih.gov/pubmed/36153625
http://dx.doi.org/10.1186/s13063-022-06719-6
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