NCT02267681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

1.6 years

First QC Date

October 14, 2014

Last Update Submit

June 28, 2016

Conditions

Digestive System DiseasesDisorientation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient and endoscopist satisfaction

    following the procedure

  • Pain

    during the 30 minutes after the termination of the procedure

  • Side effects

    during the 30 minutes after the termination of the procedure

Study Arms (3)

Group A

EXPERIMENTAL

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: AlfentanilDrug: Propofol

Group F

EXPERIMENTAL

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: FentanylDrug: Propofol

Group P

ACTIVE COMPARATOR

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

Interventions

FentanylDRUG

Intravenous fentanyl for sedation/analgesia

Also known as: Talinat
Group F
AlfentanilDRUG

Intravenous alfentanyl for sedation/analgesia

Also known as: Rapifen
Group A
PropofolDRUG

Intravenous propofol for sedation

Also known as: Diprivan
Group AGroup FGroup P

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages between 18-65
  • American Society of Anesthesiologists classification I-III
  • Patients scheduled to undergo elective colonoscopy or endoscopy and colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University Dr Rıdvan Ege Hospital

Ankara, 06520, Turkey (Türkiye)

Location

Related 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. doi: 10.1055/s-2007-1008949.

    PMID: 8026371BACKGROUND

  • 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.

    PMID: 24565243BACKGROUND

MeSH Terms

Conditions

Digestive System DiseasesConfusion

Interventions

FentanylAlfentanilPropofol

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Perihan Ekmekçi, MD

    Ufuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 17, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

TU(1)