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Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304342
First Posted: February 25, 2011
Last Update Posted: August 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens
  Purpose
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).

Condition Intervention
Chronic Pain Drug: Remifentanil Drug: Fentanyl Drug: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Argyro Fassoulaki, University of Athens:

Primary Outcome Measures:
  • Propofol requirements [ Time Frame: 30 min, 60 min and if not full recovery 120 min ]

Secondary Outcome Measures:
  • Speed of recovery [ Time Frame: 30, 60 and 120 min ]
  • postoperative pain [ Time Frame: 30, 60, and 120 minutes ]
  • early cognitive function [ Time Frame: 30, 60, and 120 minutes ]
  • patient satisfaction [ Time Frame: 30, 60, and 120 minutes ]
  • endoscopist satisfaction [ Time Frame: 30, 60, and 120 minutes ]

Enrollment: 180
Study Start Date: February 2011
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Remifentanil
Remifentanil 1 microgram/kg/h along with propofol infusion
Drug: Remifentanil
1 microgram/kg/h, continuous infusion, 5 min before and during the ERCP
Other Name: Ultiva
Active Comparator: Fentanyl
Fentanyl 200 micrograms intranasally
Drug: Fentanyl
Intranasal fentanyl 200 micrograms 5 min before the ERCP
Placebo Comparator: Normal saline
Normal saline intravenously and intranasally
Drug: Normal saline
Normal saline intravenously and intranasally

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients both sexes
  • ASA I-III
  • aged between 45 and 75 years old
  • scheduled for interventional ERCP

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304342


Locations
Greece
Department of Anesthesiology, Aretaieio Hospital
Athens, Greece, 11528
Sponsors and Collaborators
University of Athens
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Argyro Fassoulaki, MD, PhD, DEAA, University of Athens
ClinicalTrials.gov Identifier: NCT01304342     History of Changes
Other Study ID Numbers: M-17, M-18/21-12-2010
First Submitted: February 24, 2011
First Posted: February 25, 2011
Last Update Posted: August 5, 2013
Last Verified: March 2012

Keywords provided by Argyro Fassoulaki, University of Athens:
Propofol
remifentanil
fentanyl
ERCP
Quality of sedation
recovery
satisfaction
respiratory depression

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Propofol
Remifentanil
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia