Clinical trial NCT02267681: Opioid Effects on Cognitive Function Following Colonoscopy
Official title: The Effects of Fentanyl and Alfentanil as an Adjunct to Propofol on Cognitive Functions for Sedation in Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Digestive System Diseases
Disorientation
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: cognitive dysfunction
timeFrame: during the 30 minutes after the termination of the procedure
Secondary outcomes:
measure: Patient and endoscopist satisfaction
timeFrame: following the procedure
measure: Pain
timeFrame: during the 30 minutes after the termination of the procedure
measure: Side effects
timeFrame: during the 30 minutes after the termination of the procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University Dr Rıdvan Ege Hospital
Study officials:
affiliation: Ufuk University
name: Perihan Ekmekçi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.