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

Phase 4

Completed

Interventions: Drug: Midazolam
Drug: Remifentanil
Drug: Meperidine
Drug: Propofol

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Group MM	Midazolam	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 MM	Meperidine	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 RP	Remifentanil	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 RP	Propofol	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

Primary Outcome Measures

Name	Time	Method
Change in Cognitive Function	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 Outcome Measures

Name	Time	Method
Heart Rate	Baseline and 1,2,3,5,10,15 and 20 minutes	Heart rate as measured in beats per minute
Change in Visual Analogue Scale Scores From the Baseline	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
Mean Arterial Pressure	Baseline and 1,2,3,5,10,15 and 20 minutes	mean arterial blood pressure as measured in mmHg
Peripheral Oxygen Saturation	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.