Clinical trial NCT02486328: The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy
Official title: The Effect of Different Sedation Regimes Administered by Anesthesiologists or Endoscopists on Cognitive Functions in Lower Gastrointestinal System Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Dysfunction
Alteration of Cognitive Function
Keywords: Cognitive dysfunction
Colonoscopy
Sedation
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Sedation for lower gastrointestinal system endoscopies can be administered by anesthesiologists or endoscopists and cognitive dysfunction after this procedure has not been fully investigated. The aim of this study was to investigate the effect of different sedation regimes applied by anesthesiologists or endoscopists on early cognitive dysfunction. Following ethics committee approval and written informed consent, 100 patients were randomly divided into two groups. In Group MM where drug regime was solely determined by endoscopists, 2 mg midazolam and 20mg meperidine was given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) was given when facial pain scale (FPS) was greater than 3. In Group RP where drug regime was solely determined by anesthesiologists, 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus was administered and additional 0,5 mcg/kg remifentanil bolus was given when FPS was greater than 3. Bispectral index (BIS) and hemodynamic monitorization was carried out throughout the procedure and BIS 60-80 with FPS\<3 was targeted. The time to Observer Assessment of Alertness/Sedation Scale (OAAS) score to reach 3 was measured after the procedure and Trieger Dot Test (TDT) and Digit Symbol Substitution Test (DSST) was repeated at 5th, 15th and 30th minutes.

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\<26
* Amsterdam Preoperative Anxiety and Information Scale (APAIS ) score \>10
* Advanced cardiopulmonary or psychiatric disease
* Chronic alcohol abuse
* Morbid obesity
* Known allergy to study drugs

Primary outcomes:
measure: Change in Cognitive Function
timeFrame: Baseline and 5, 15, 30 minutes after the procedure
measure: Change in Cognitive Function
timeFrame: Baseline and 5, 15, 30 minutes after the procedure
Secondary outcomes:
measure: Change in Visual Analogue Scale Scores From the Baseline
timeFrame: Baseline and 5, 15, 30 minutes after the procedure
measure: Heart Rate
timeFrame: Baseline and 1,2,3,5,10,15 and 20 minutes
measure: Mean Arterial Pressure
timeFrame: Baseline and 1,2,3,5,10,15 and 20 minutes
measure: Peripheral Oxygen Saturation
timeFrame: Baseline and 1,2,3,5,10,15 and 20 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Ufuk University
name: Perihan Ekmekçi, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen LB, Dubovsky AN, Aisenberg J, Miller KM. Propofol for endoscopic sedation: A protocol for safe and effective administration by the gastroenterologist. Gastrointest Endosc. 2003 Nov;58(5):725-32. doi: 10.1016/s0016-5107(03)02010-8.
citation: Ferreira AO, Cravo M. Sedation in gastrointestinal endoscopy: Where are we at in 2014? World J Gastrointest Endosc. 2015 Feb 16;7(2):102-9. doi: 10.4253/wjge.v7.i2.102.
citation: Padmanabhan U, Leslie K, Eer AS, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg. 2009 Nov;109(5):1448-55. doi: 10.1213/ane.0b013e3181a6ad31. Epub 2009 Jul 17.