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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Gastrointestinal Dysfunction Alteration of Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group MM

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

Group Type OTHER

Midazolam

Intervention Type DRUG

Dosage adjustment

Meperidine

Intervention Type DRUG

Dosage adjustment

Group RP

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

Group Type OTHER

Remifentanil

Intervention Type DRUG

Dosage adjustment

Propofol

Intervention Type DRUG

Dosage adjustment

Interventions

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Midazolam

Dosage adjustment

Intervention Type DRUG

Meperidine

Dosage adjustment

Intervention Type DRUG

Remifentanil

Dosage adjustment

Intervention Type DRUG

Propofol

Dosage adjustment

Intervention Type DRUG

Other Intervention Names

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Versed Demerol Ultiva Diprivan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No