Opioid Effects on Cognitive Function Following Colonoscopy

Study Overview
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Brief Summary
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This study aims to compare the effects of fentanyl and alfentanil on postprocedural cognitive function in elective endoscopy. 150 patients will be enrolled in the study. Patients meeting eligibility criteria will be randomly allocated to three groups. The patients in Group A will be given propofol and alfentanil. The patients in Group F will be given propofol and fentanyl. Group P is designated as the control group and the patients will be given propofol for sedation. Awareness, vital signs and pain will be evaluated. Side effects will be recorded. Patient and endoscopist satisfaction will be evaluated.

Detailed Description
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In this study we aimed to compare the effects of sedation provided by propofol with the addition of the short-acting opioid alfentanil and long-acting opioid fentanyl on cognitive functions, pain, side effects during the procedure and the endoscopist and patient satisfaction. Following the approval of Kırıkkale University ethics committee, 150 patients ages between 18 and 65 ASA I-III scheduled for elective endoscopy and colonoscopy will be enrolled in the study. After obtaining written informed consent, APAIS (The Amsterdam Preoperative Anxiety and Information Scale) and MMTS (Mini Mental Test Scoring) tests will given to patients. Following TDT (Trieger Dot Test) and DSST (Digit Symbol Substitution Test), the patients will be randomly allocated to either Propofol-Alfentanil (Group A), Propofol-Fentanyl (Group F) or Propofol-Control (Group P) which consists of 50 patients each. The patients in Group A will be given 100 mcg/kg/min propofol infusion and 10 mcg/kg loading dose of alfentanil and 5 mcg/kg additional bolus of alfentanil whenever FPS (Faces Pain Scale) is greater than 3 or the patients can not tolerate the procedure. The patients in Group F will be given 100 mcg/kg/min propofol infusion and 1 mcg/kg loading dose of fentanyl and 5 mcg/kg additional bolus of fentanyl whenever FPS (Faces Pain Scale) is greater than 3 or the patients could not tolerate the procedure. Group P is designated as the control group and the patients will be given 100mcg/kg/min infusion and sedation will be achieved via 1 mg/kg propofol loading dose and 0.5 mg/kg propofol additional bolus will be given whenever the patients can not tolerate the procedure or FPS is greater than 3. BIS values, mean arterial pressures, heart rates, peripheral oxygen saturations will be recorded in all three groups. FPS and VAS (Visual Analogue Scale) values will be evaluated. Patients with intraprocedural desaturation, hypo- or hypertension, brady- or tachycardia, nausea, vomiting and apnea will be recorded. Total amounts of drugs administered will be recorded. Infusions will be ceased at the end of the procedure and the time for OAAS/S to exceed 3 will be recorded and TDT and DSST will be repeated at 5, 15 and 30th minutes. Patient and endoscopist satisfaction will be evaluated in all cases.

Official Title
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The Effects of Fentanyl and Alfentanil as an Adjunct to Propofol on Cognitive Functions for Sedation in Colonoscopy

Conditions
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Digestive System Diseases, Disorientation

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Alfentanil
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages between 18-65 American Society of Anesthesiologists classification I-III Patients scheduled to undergo elective colonoscopy or endoscopy and colonoscopy Exclusion Criteria: Patients younger than 18 or older than 65 Mini mental test score < 26 APAIS (The Amsterdam Preoperative Anxiety and Information Scale) >10 Serious systemic disease Neuropsychiatric disorder Chronic alcohol abuse Morbid obesity History of anesthesia in the last 7 days Known allergy to study drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>The patients in Group A will be given 100 mcg/kg/min propofol infusion and 10 mcg/kg loading dose of alfentanil and 5 mcg/kg additional bolus of alfentanil whenever FPS (Faces Pain Scale) is greater than 3 or the patients can not tolerate the procedure. | Drug: Alfentanil<br>* Intravenous alfentanyl for sedation/analgesia<br>* Other names: Rapifen;Drug: Propofol<br>* Intravenous propofol for sedation<br>* Other names: Diprivan;|
| Experimental: Group F<br>The patients in Group F will be given 100 mcg/kg/min propofol infusion and 1 mcg/kg loading dose of fentanyl and 5 mcg/kg additional bolus of fentanyl whenever FPS (Faces Pain Scale) is greater than 3 or the patients can not tolerate the procedure. | Drug: Fentanyl<br>* Intravenous fentanyl for sedation/analgesia<br>* Other names: Talinat;Drug: Propofol<br>* Intravenous propofol for sedation<br>* Other names: Diprivan;|
| Active Comparator: Group P<br>Group P is designated as the control group and the patients will be given 100mcg/kg/min infusion and sedation will be achieved via 1 mg/kg propofol loading dose and 0.5 mg/kg propofol additional bolus will be given whenever the patients can not tolerate the procedure or FPS is greater than 3. | Drug: Propofol<br>* Intravenous propofol for sedation<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive dysfunction | as evaluated using Trieger dot test,Mini mental test and Digit symbol substitution test | during the 30 minutes after the termination of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and endoscopist satisfaction | as evaluated using a 5-point Likert scale | following the procedure | 
| Pain | as evaluated using VAS score | during the 30 minutes after the termination of the procedure | 
| Side effects | hypotension, hypertension, bradycardia, tachycardia, apnea, nausea and vomiting | during the 30 minutes after the termination of the procedure |