Clinical trial · Interventional
Monitored Anesthesia Care With Propofol Plus Remifentanil During Endoscopic Submucosal Dissection: Evaluation of Bispectral Index Monitoring
NCT01921283CI-TRIAL-00011759completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There are clinical usefulness issues associated with bispectral index (BIS) for sedation of endoscopic submucosal dissection (ESD). However, the clinical usefulness of BIS for deep sedation is incompletely described. The purpose of this study is to show that BIS-guided sedation is safe and useful clinically and may provide stable sedation status to physicians and patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIS sensor attachment | Device | — | UNRESOLVED |
| no- BIS sensor attachment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BIS group
- description
- The BIS group (n=90) was monitored for sedation depth using BIS during ESD.
- interventionNames
- Device: BIS sensor attachment
- type
- ACTIVE_COMPARATOR
- label
- No-BIS group
- description
- The no-BIS group (n=90) was monitored by observer's assessment alertness/sedation scale (OAA/S).
- interventionNames
- Drug: no- BIS sensor attachment
Primary outcomes (1)
- measure
- procedure satisfaction score of propofol addition
- timeFrame
- an average time for 1 week from propofol addition
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I to II. Exclusion Criteria: * body mass index (BMI) over 35 (Kg/m2) * hepatic or renal insufficiency * history of allergy to the drugs used * history of administration of anxiolytics, narcotics, antipsychotics, opioid.
References
Publications (8)
- BACKGROUNDBell JK, Laasch HU, Wilbraham L, England RE, Morris JA, Martin DF. Bispectral index monitoring for conscious sedation in intervention: better, safer, faster. Clin Radiol. 2004 Dec;59(12):1106-13. doi: 10.1016/j.crad.2004.04.008. PMID 15556593
- BACKGROUNDSugimoto T, Okamoto M, Mitsuno Y, Kondo S, Ogura K, Ohmae T, Mizuno H, Yoshida S, Isomura Y, Yamaji Y, Kawabe T, Omata M, Koike K. Endoscopic submucosal dissection is an effective and safe therapy for early gastric neoplasms: a multicenter feasible study. J Clin Gastroenterol. 2012 Feb;46(2):124-9. doi: 10.1097/MCG.0b013e31822f3988. PMID 21959325
- BACKGROUNDKim SG. Endoscopic treatment for early gastric cancer. J Gastric Cancer. 2011 Sep;11(3):146-54. doi: 10.5230/jgc.2011.11.3.146. Epub 2011 Sep 29. PMID 22076219
- BACKGROUNDDumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11. PMID 21072716
- BACKGROUNDCohen LB, Delegge MH, Aisenberg J, Brill JV, Inadomi JM, Kochman ML, Piorkowski JD Jr; AGA Institute. AGA Institute review of endoscopic sedation. Gastroenterology. 2007 Aug;133(2):675-701. doi: 10.1053/j.gastro.2007.06.002. No abstract available. PMID 17681185
- BACKGROUNDStandards of Practice Committee of the American Society for Gastrointestinal Endoscopy; Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029. No abstract available.