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

NCT02486328 | Completed Phase 4 Results

• 1 other identifier: UfukU
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Dysfunction; Alteration of Cognitive Function

Keywords

Cognitive dysfunction; Colonoscopy; Sedation

Outcome Measures

Primary Outcomes (2)

• Change in Cognitive Function

  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.

  Baseline and 5, 15, 30 minutes after the procedure

• Change in Cognitive Function

  As measured by Digit Symbol Substitution Test. Scale range 0-9. No cut-off value. Higher results represent better outcomes

  Baseline and 5, 15, 30 minutes after the procedure

Secondary Outcomes (4)

• Change in Visual Analogue Scale Scores From the Baseline

  Baseline and 5, 15, 30 minutes after the procedure

• Heart Rate

  Baseline and 1,2,3,5,10,15 and 20 minutes

• Mean Arterial Pressure

  Baseline and 1,2,3,5,10,15 and 20 minutes

• Peripheral Oxygen Saturation

  Baseline and 1,2,3,5,10,15 and 20 minutes

Study Arms (2)

Group MM

OTHER

2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3

Drug: Midazolam; Drug: Meperidine

Group RP

OTHER

100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3

Drug: Remifentanil; Drug: Propofol

Interventions

Midazolam DRUG

Dosage adjustment

Also known as: Versed

Group MM

Meperidine DRUG

Dosage adjustment

Also known as: Demerol

Group MM

Remifentanil DRUG

Dosage adjustment

Also known as: Ultiva

Group RP

Propofol DRUG

Dosage adjustment

Also known as: Diprivan

Group RP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18-65 years of age (ASA I-III risk groups), scheduled for elective colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ufuk University: lead

Related Publications (3)

• 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.

  PMID: 14595310 RESULT

• 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.

  PMID: 25685266 RESULT

• 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.

  PMID: 19617584 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Midazolam; Meperidine; Remifentanil; Propofol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr Perihan Ekmekçi
• Organization: Ufuk University Faculty of Medicine

erdogduperi@gmail.com

+903122044000

Study Officials

• Perihan Ekmekçi, Assoc Prof

  Ufuk University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 1, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 3, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share