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Trial · NCT02486328

The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy

NCT02486328, Phase 4, Completed, Ufuk University; results first posted 2020-09-03

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy. Trials, record NCT02486328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02486328

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy
NCT number
NCT02486328
Status
Completed
Phases
Phase 4
Enrollment
103 participants, actual
Lead sponsor
Ufuk University
Conditions
Gastrointestinal Dysfunction, Alteration of Cognitive Function
Interventions
Midazolam, Meperidine, Remifentanil, Propofol
First posted
2015-07-01
Last updated
2020-09-03
Results first posted
2020-09-03

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Cognitive FunctionBaseline 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.
PrimaryChange in Cognitive FunctionBaseline and 5, 15, 30 minutes after the procedureAs measured by Digit Symbol Substitution Test. Scale range 0-9. No cut-off value. Higher results represent better outcomes
SecondaryChange in Visual Analogue Scale Scores From the BaselineBaseline and 5, 15, 30 minutes after the procedurePain as measured by Visual Analogue Scale. Range 1-10. No cut-off value, Higher results represent worse outcomes
SecondaryHeart RateBaseline and 1,2,3,5,10,15 and 20 minutesHeart rate as measured in beats per minute
SecondaryMean Arterial PressureBaseline and 1,2,3,5,10,15 and 20 minutesmean arterial blood pressure as measured in mmHg
SecondaryPeripheral Oxygen SaturationBaseline and 1,2,3,5,10,15 and 20 minutesperipheral oxygen saturation as measured by pulse oximeter. Units are percentages, Scale range 0-100.

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Cognitive FunctionBaseline and 5, 15, 30 minutes after the procedureunits on a scaleMEAN
PRIMARYChange in Cognitive FunctionBaseline and 5, 15, 30 minutes after the procedureunits on a scaleMEAN
SECONDARYChange in Visual Analogue Scale Scores From the BaselineBaseline and 5, 15, 30 minutes after the procedureunits on a scaleMEAN
SECONDARYHeart RateBaseline and 1,2,3,5,10,15 and 20 minutesbeats per minuteMEAN
SECONDARYMean Arterial PressureBaseline and 1,2,3,5,10,15 and 20 minutesmmHgMEAN
SECONDARYPeripheral Oxygen SaturationBaseline and 1,2,3,5,10,15 and 20 minutesPercent of oxygenated hemoglobinMEAN

Results by group66

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in Cognitive FunctionGroup MM5th minute47.5Standard Deviation 10.6units on a scale
Change in Cognitive FunctionGroup RP5th minute40.4Standard Deviation 6.8units on a scale
Change in Cognitive FunctionGroup MM15th minute44.7Standard Deviation 9.2units on a scale
Change in Cognitive FunctionGroup RP15th minute37.8Standard Deviation 5.6units on a scale
Change in Cognitive FunctionGroup MM30th minute42Standard Deviation 7.9units on a scale
Change in Cognitive FunctionGroup RP30th minute35.4Standard Deviation 6units on a scale
Change in Cognitive FunctionGroup MM5th minute1.6Standard Deviation 1.2units on a scale
Change in Cognitive FunctionGroup RP5th minute2Standard Deviation 1.6units on a scale
Change in Cognitive FunctionGroup MM15th minute2.1Standard Deviation 1.4units on a scale
Change in Cognitive FunctionGroup RP15th minute2.8Standard Deviation 1.8units on a scale

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDGroup MM52
Overall StudySTARTEDGroup RP51
Overall StudyCOMPLETEDGroup MM50
Overall StudyCOMPLETEDGroup RP50
Overall StudyNOT COMPLETEDGroup MM2
Overall StudyNOT COMPLETEDGroup RP1

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityGroup MM
Total, all-cause mortalityGroup RP
Total, other adverse eventsGroup MM050
Total, other adverse eventsGroup RP050
Total, serious adverse eventsGroup MM050
Total, serious adverse eventsGroup RP050

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
14595310RESULTPubMed
19617584RESULTPubMed
25685266RESULTPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Group MM vs Group RP: serious adverse events

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed as
Symbol CodingPrimary outcome

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02486328

GET https://conductscience.org/api/trials/v1/NCT02486328/results?page=2