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

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. Identifier: NCT01304342
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : August 5, 2013
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens

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).

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Remifentanil Drug: Fentanyl Drug: Normal saline Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
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
Study Start Date : February 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Speed of recovery [ Time Frame: 30, 60 and 120 min ]
  2. postoperative pain [ Time Frame: 30, 60, and 120 minutes ]
  3. early cognitive function [ Time Frame: 30, 60, and 120 minutes ]
  4. patient satisfaction [ Time Frame: 30, 60, and 120 minutes ]
  5. endoscopist satisfaction [ Time Frame: 30, 60, and 120 minutes ]

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

Inclusion Criteria:

  • patients both sexes
  • 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

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 identifier (NCT number): NCT01304342

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

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

Keywords provided by Argyro Fassoulaki, University of Athens:
Quality of sedation
respiratory depression

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