Skip to main content
OpenTrials
Completed

NCT Number: NCT02267681

Opioid Effects on Cognitive Function Following 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ufuk University Dr Rıdvan Ege Hospital

Ankara, 06520, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

Intravenous fentanyl for sedation/analgesia

Other names: Talinat

alfentanil

Drug

Intravenous alfentanyl for sedation/analgesia

Other names: Rapifen

Propofol

Drug

Intravenous propofol for sedation

Other names: Diprivan

Primary outcomes

  1. cognitive dysfunction

    Time frame: during the 30 minutes after the termination of the procedure

    as evaluated using Trieger dot test,Mini mental test and Digit symbol substitution test

Secondary outcomes

  1. Patient and endoscopist satisfaction

    Time frame: following the procedure

    as evaluated using a 5-point Likert scale

  2. Pain

    Time frame: during the 30 minutes after the termination of the procedure

    as evaluated using VAS score

  3. Side effects

    Time frame: during the 30 minutes after the termination of the procedure

    hypotension, hypertension, bradycardia, tachycardia, apnea, nausea and vomiting

Sponsors and collaborators

Lead sponsor

Perihan Ekmekçi

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2014
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.