Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids
The Effect of Intranasal Fentanyl Versus Remifentanil Infusion on Propofol Requirements During Elective Therapeutic ERCP, as Well on the Recovery, Pain, and Early Cognitive Function: A Randomized Control Trial
1 other identifier
interventional
180
1 country
1
Brief Summary
Addition of fentanyl or remifentanil to the propofol produced sedation for scheduled ERCP will decrease the propofol requirements for predetermined sedation levels (as shown by Bispectral Index Monitor (BIS) monitor), will be associated with faster recovery monitored by Ramsay's and Observer's Assessment of Alertness/Sedation (OAAS) scores and BIS, less postoperative pain (assessed by Visual Analogue Scale=VAS) and less early cognitive impairment after sedation (as assessed by the MiniMental test).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Feb 2011
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedAugust 5, 2013
March 1, 2012
1.9 years
February 24, 2011
August 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Propofol requirements
30 min, 60 min and if not full recovery 120 min
Secondary Outcomes (5)
Speed of recovery
30, 60 and 120 min
postoperative pain
30, 60, and 120 minutes
early cognitive function
30, 60, and 120 minutes
patient satisfaction
30, 60, and 120 minutes
endoscopist satisfaction
30, 60, and 120 minutes
Study Arms (3)
Remifentanil
ACTIVE COMPARATORRemifentanil 1 microgram/kg/h along with propofol infusion
Fentanyl
ACTIVE COMPARATORFentanyl 200 micrograms intranasally
Normal saline
PLACEBO COMPARATORNormal saline intravenously and intranasally
Interventions
1 microgram/kg/h, continuous infusion, 5 min before and during the ERCP
Eligibility Criteria
You may qualify if:
- patients both sexes
- ASA I-III
- aged between 45 and 75 years old
- scheduled for interventional ERCP
You may not qualify if:
- patients receiving opioids or other analgesics, sedatives, hypnotics
- allergic to drugs used in the study protocol
- alcoholism
- refuse to sign the informed consent and chronic pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology, Aretaieio Hospital
Athens, 11528, Greece
Related Publications (1)
Fassoulaki A, Iatrelli I, Vezakis A, Polydorou A. Deep sedation for endoscopic cholangiopancreatography with or without pre or intraprocedural opioids: A double-blind randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):602-8. doi: 10.1097/EJA.0000000000000187.
PMID: 25405276DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, DEAA
Study Record Dates
First Submitted
February 24, 2011
First Posted
February 25, 2011
Study Start
February 1, 2011
Primary Completion
January 1, 2013
Study Completion
July 1, 2013
Last Updated
August 5, 2013
Record last verified: 2012-03