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NCT02486328
The Effect of Different Sedation Regimes Administered by Anesthesiologists or Endoscopists on Cognitive Functions in Lower Gastrointestinal System Endoscopy
Phase 4 trial testing Midazolam in Gastrointestinal Dysfunction in 103 participants. Completed in 1 June 2015.
1 June 2015
Quick facts
| Lead sponsor | Ufuk University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 103 |
| Start date | 1 May 2015 |
| Primary completion | 1 June 2015 |
| Estimated completion | 1 June 2015 |
Drugs / interventions tested
- Midazolam (midazolam) — full drug profile →
- Meperidine — full drug profile →
- Remifentanil — full drug profile →
- Propofol (Propofol) — full drug profile →
Conditions studied
- Gastrointestinal Dysfunction — all drugs for Gastrointestinal Dysfunction →
- Alteration of Cognitive Function — all drugs for Alteration of Cognitive Function →
Sponsor
Ufuk University
Who can join
Adults 18 to 65, any sex, with Gastrointestinal Dysfunction or Alteration of Cognitive Function. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in Cognitive Function
Time frame: Baseline and 5, 15, 30 minutes after the procedure
As measured by Trieger Dot Test. The test does not have an upper limit; the time taken to complete the test is added to the number of dots missed by the patient and a result is obtained. The lowest score possible is 0. Higher values represent worse outcomes. -
Change in Cognitive Function
Time frame: Baseline and 5, 15, 30 minutes after the procedure
As measured by Digit Symbol Substitution Test. Scale range 0-9. No cut-off value. Higher results represent better outcomes
Sponsor's own description
There are different sedation regimes for lower gastrointestinal system endoscopy which can be administered by anesthesiologists and non-anesthesiologists. This study aims to compare the effects of propofol/remifentanil combination and midazolam/meperidine combination on early cognitive function following lower gastrointestinal system endoscopies.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of Different Sedation Regimes on Cognitive Functions in Colonoscopy.
Ekmekçi P, Erkan G, Yilmaz H, K Kazbek B, et al · · 2017 · cited 8× · PMID 29201800 · DOI 10.5005/jp-journals-10018-1239
Verify or expand the search:
- PubMed search for NCT02486328
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07443254 — Prospective IR-led Sedation Feasibility · Phase 1, PHASE2 · recruiting
Other recruiting trials for Gastrointestinal Dysfunction
Currently open trials in the same condition.
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Other Ufuk University trials
Trials by the same sponsor.
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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 NCT02486328 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ufuk University
- Last refreshed: 18 August 2020
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/NCT02486328.
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