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

Ufuk University

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Dysfunction; Alteration of Cognitive Function

Treatments: Drug: Propofol; Drug: Remifentanil; Drug: Midazolam; Drug: Meperidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02486328

UfukU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103 participants in 2 patient groups

Group MM

Other group

Description:

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

Treatment:

Drug: Meperidine

Drug: Midazolam

Group RP

Other group

Description:

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

Treatment:

Drug: Remifentanil

Drug: Propofol