Opioid Effects on Cognitive Function Following Colonoscopy

Digestive System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267681
• Other study ID #: Ufuk University
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2014
• Last updated: June 28, 2016
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Ufuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Confusion
• Digestive System Diseases
• Disorientation
• Gastrointestinal Diseases

Intervention

Drug:
• Fentanyl
Intravenous fentanyl for sedation/analgesia
• Alfentanil
Intravenous alfentanyl for sedation/analgesia
• Propofol
Intravenous propofol for sedation

Locations

Country	Name	City	State
Turkey	Ufuk University Dr Ridvan Ege Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Perihan Ekmekçi

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Türk HS, Aydogmus M, Unsal O, Köksal HM, Açik 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient and endoscopist satisfaction	as evaluated using a 5-point Likert scale	following the procedure	No
Secondary	Pain	as evaluated using VAS score	during the 30 minutes after the termination of the procedure	No
Secondary	Side effects	hypotension, hypertension, bradycardia, tachycardia, apnea, nausea and vomiting	during the 30 minutes after the termination of the procedure	Yes