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NCT03461029
Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies
trial testing BIS monitor in Colonoscopy in 196 participants. Completed in 20 February 2018.
30 December 2017
Quick facts
| Lead sponsor | Hospital Galdakao-Usansolo |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 196 |
| Start date | 30 January 2016 |
| Primary completion | 30 December 2017 |
| Estimated completion | 20 February 2018 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- BIS monitor
Conditions studied
- Colonoscopy — all drugs for Colonoscopy →
Sponsor
Hospital Galdakao-Usansolo
Who can join
Adults 18 to 80, any sex, with Colonoscopy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to establish and identify the level of sedation that is performed in the endoscopy rooms of Galdakao Hospital. To do this, the investigators used the BIS monitoring system, which obtains objective values in real time from the anesthesia performed. The monitoring is completed with basic parameters validated by European guidelines (heart rate, blood pressure, oxygen saturation and respiratory rate), capnography and Ramsay sedation scale, widely validated for use outside the operating room. The main work hypothesis was that in at least 10% of the patients BIS values compatible with moderate or deep sedation would be obtained (BIS \<65).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03461029
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BIS monitor
Trials testing the same drug.
- NCT04466579 — Influence of Monitoring the Depth of General Anesthesia Upon the Incidence of PONV and Emergence Delirium in Children Un · NA · completed
- NCT03911544 — Bispectral Index and Surgical Field · NA · completed
- NCT03453359 — Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial · NA · completed
Other recruiting trials for Colonoscopy
Currently open trials in the same condition.
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- NCT07171853 — The Carbon Footprint Study of Colonoscopy · recruiting
- NCT07355777 — Video Tutorial and Oral Explanation Vs Oral Explanation Alone in Colonoscopy Preparation · NA · recruiting
Other Hospital Galdakao-Usansolo trials
Trials by the same sponsor.
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- NCT05574790 — Identification of Multimorbid Patients With a Higher Probability of Readmission and Mortality · completed
- NCT04188990 — Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition · NA · completed
- NCT04463706 — COVID19 Severity Prediction and Health Services Research Evaluation · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03461029 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Galdakao-Usansolo
- Last refreshed: 9 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03461029.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing