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NCT Number: NCT02486328

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

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.

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Key information

Conditions

Gastrointestinal Dysfunction Alteration of Cognitive Function Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Dosage adjustment

Other names: Versed

Meperidine

Drug

Dosage adjustment

Other names: Demerol

Remifentanil

Drug

Dosage adjustment

Other names: Ultiva

Propofol

Drug

Dosage adjustment

Other names: Diprivan

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Change in Visual Analogue Scale Scores From the Baseline

    Time frame: Baseline and 5, 15, 30 minutes after the procedure

    Pain as measured by Visual Analogue Scale. Range 1-10. No cut-off value, Higher results represent worse outcomes

  2. Heart Rate

    Time frame: Baseline and 1,2,3,5,10,15 and 20 minutes

    Heart rate as measured in beats per minute

  3. Mean Arterial Pressure

    Time frame: Baseline and 1,2,3,5,10,15 and 20 minutes

    mean arterial blood pressure as measured in mmHg

  4. Peripheral Oxygen Saturation

    Time frame: Baseline and 1,2,3,5,10,15 and 20 minutes

    peripheral oxygen saturation as measured by pulse oximeter. Units are percentages, Scale range 0-100.

Sponsors and collaborators

Lead sponsor

Ufuk University

Other

Registry information

Official study title

The Effect of Different Sedation Regimes Administered by Anesthesiologists or Endoscopists on Cognitive Functions in Lower Gastrointestinal System Endoscopy

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2015
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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