Trial reportPloS one2015
Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial.
Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01806753 (Performance of Endoscopic Submucosal Dissection According to the Sedation Method), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Performance of Endoscopic Submucosal Dissection According to the Sedation Method
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- Korean clinical practice guidelines for diagnostic and procedural sedation.Korean journal of anesthesiology · 2024Guideline
- Patient satisfaction after endoscopic submucosal dissection under propofol-based sedation: a small premedication makes all the difference.Surgical endoscopy · 2017Trial
- Comparison of the Efficacy and Safety of General Anesthesia and Sedation Management for Esophageal Endoscopic Submucosal Dissection: A Retrospective Study.JMA journal · 2026Article
- Article
- Comparison of Nasopharyngeal Airway with Endoscopic Respiratory Mask for Hypoxemia in Painless Gastrointestinal Endoscopy in Obese Outpatients: Study Protocol for a Randomized Controlled Trial.Medical devices (Auckland, N.Z.) · 2025Article
- Article
- Article
- Clinical Outcomes and Adverse Events of Gastric Endoscopic Submucosal Dissection of the Mid to Upper Stomach under General Anesthesia and Monitored Anesthetic Care.Clinical endoscopy · 2022Article
- Effectiveness of topical budesonide in preventing esophageal strictures after endoscopic resection of esophageal cancer.Endoscopy international open · 2020Article
- Comparison of general anesthesia and conscious sedation in procedure-related complications during esophageal endoscopic submucosal dissection.Surgical endoscopy · 2020Article
- Sedation Strategies for Procedures Outside the Operating Room.Yonsei medical journal · 2019Review
- Commentary on "Efficacy of Endoscopic Submucosal Dissection of Esophageal Neoplasms under General Anesthesia".Clinical endoscopy · 2019Article
- Propofol sedation without endotracheal intubation is safe for endoscopic submucosal dissection in the esophagus and stomach.United European gastroenterology journal · 2019Observational
- Polysomnographic assessment of respiratory disturbance during deep propofol sedation for endoscopic submucosal dissection of gastric tumors.World journal of gastrointestinal endoscopy · 2018Article
- Efficacy and safety of sedation during endoscopic submucosal dissection of gastric cancers using a comparative trial of propofol versus midazolam.Endoscopy international open · 2018Article
- Propofol-Based Sedation Versus General Anesthesia for Endoscopic Submucosal Dissection.Medicine · 2016Article
- Outcomes of Propofol Sedation During Emergency Endoscopy Performed for Upper Gastrointestinal Bleeding.Digestive diseases and sciences · 2016Article
- Article
Corrections and comments
- Erratum issued
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough endoscopic submucosal dissection (ESD) is routinely performed under sedation, the difference in ESD performance according to sedation method is not well known. This study attempted to prospectively assess and compare the satisfaction of the endoscopists and patient stability during ESD between two sedation methods.
methodsOne hundred and fifty-four adult patients scheduled for ESD were sedated by either the IMIE (intermittent midazolam/propofol injection by endoscopist) or CPIA (continuous propofol infusion by anesthesiologist) method. The primary endpoint of this study was to compare the level of satisfaction of the endoscopists between the two groups. The secondary endpoints included level of satisfaction of the patients, patient's pain scores, events interfering with the procedure, incidence of unintended deep sedation, hemodynamic and respiratory events, and ESD outcomes and complications.
resultsLevel of satisfaction of the endoscopists was significantly higher in the CPIA Group compared to the IMIE group (IMIE vs. CPIA; high satisfaction score; 63.2% vs. 87.2%, P=0.001). The incidence of unintended deep sedation was significantly higher in the IMIE Group compared to the CPIA Group (IMIE vs. CPIA; 17.1% vs. 5.1%, P=0.018) as well as the number of patients showing spontaneous movement or those requiring physical restraint (IMIE vs. CPIA; spontaneous movement; 60.5% vs. 42.3%, P=0.024, physical restraint; 27.6% vs. 10.3%, P=0.006, respectively). In contrast, level of satisfaction of the patients were found to be significantly higher in the IMIE Group (IMIE vs. CPIA; high satisfaction score; 85.5% vs. 67.9%, P=0.027). Pain scores of the patients, hemodynamic and respiratory events, and ESD outcomes and complications were not different between the two groups.
conclusionContinuous propofol and remifentanil infusion by an anesthesiologist during ESD can increase the satisfaction levels of the endoscopists by providing a more stable state of sedation.
trial registrationClinicalTrials.gov NCT01806753.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.