Phase 4
N=103
The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy
Gastrointestinal Dysfunction · Alteration of Cognitive Function
Bottom Line
View on ClinicalTrials.gov: NCT02486328 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Change in Cognitive Function — 47.5; 40.4; 44.7; 37.8 units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Midazolam (Drug); Meperidine (Drug); Remifentanil (Drug); Propofol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ufuk University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Function |
1.6; 2; 2.1; 2.8; 2.4; 3.5 | 0.001 sig |
| PRIMARY Change in Cognitive Function |
1.6; 2; 2.1; 2.8; 2.4; 3.5 | 0.001 sig |
| SECONDARY Change in Visual Analogue Scale Scores From the Baseline |
0.9; 0.4; 0.5; 0.4; 0.1; 0.1 | 0.001 sig |
| SECONDARY Heart Rate |
90.2; 82.6; 89.6; 81.3; 88; 76 | 0.001 sig |
| SECONDARY Mean Arterial Pressure |
105.7; 113.1; 103; 104; 104.5; 92.9 | 0.001 sig |
| SECONDARY Peripheral Oxygen Saturation |
97.2; 98.6; 97.2; 98; 97.5; 98.5 | 0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients between 18-65 years of age (ASA I-III risk groups), scheduled for elective colonoscopy
Exclusion Criteria
- Patient refusal
- Mini mental test (MMT) score 10
- Advanced cardiopulmonary or psychiatric disease
- Chronic alcohol abuse
- Morbid obesity
- Known allergy to study drugs
Data sourced from ClinicalTrials.gov (NCT02486328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.