Opioid Effects on Cognitive Function Following Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Digestive System Diseases; Disorientation
• Intervention / Treatment: Drug: Alfentanil; Drug: Propofol; Drug: Fentanyl

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06520
    • Ufuk University Dr Rıdvan Ege Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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; Intravenous alfentanyl for sedation/analgesia; Other Names: Rapifen; Drug: Propofol; Intravenous propofol for sedation; Other Names: Diprivan
Experimental: Group F; 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: Propofol; Intravenous propofol for sedation; Other Names: Diprivan; Drug: Fentanyl; Intravenous fentanyl for sedation/analgesia; Other Names: Talinat
Active Comparator: Group P; 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; Intravenous propofol for sedation; Other Names: Diprivan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Perihan Ekmekçi
• Investigators: Principal Investigator: Perihan Ekmekçi, MD, Ufuk University Faculty of Medicine

Publications and helpful links

General Publications

• Froehlich F, Gonvers JJ, Fried M. Conscious sedation, clinically relevant complications and monitoring of endoscopy: results of a nationwide survey in Switzerland. Endoscopy. 1994 Feb;26(2):231-4. doi: 10.1055/s-2007-1008949.
• Turk HS, Aydogmus M, Unsal O, Koksal HM, Acik ME, Oba S. Sedation-analgesia in elective colonoscopy: propofol-fentanyl versus propofol-alfentanil. Braz J Anesthesiol. 2013 Jul-Aug;63(4):352-7. doi: 10.1016/j.bjane.2012.07.007. Epub 2013 Aug 13.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Gastrointestinal Diseases; Digestive System Diseases; Confusion; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Propofol; Alfentanil
• Other Study ID Numbers: Ufuk University