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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens
ClinicalTrials.gov Identifier:
NCT01304342
First received: February 24, 2011
Last updated: August 2, 2013
Last verified: March 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Athens:

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

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

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

Detailed Description:

Patients After obtaining approval from the Institutional Review Board (IRB) adult patients ASA I-III aged between 45 and 75 yrs scheduled for elective therapeutic ERCP are enrolled in the study. All patients are informed and asked to give written informed consent. Those with chronic pain, consuming opioids or other analgesics, sedatives, hypnotics, allergic to the drugs to be used in the study protocol, or patients who refuse to give written informed consent are excluded from the study.

Randomization and blindness Randomization was done by a Research Randomizer program, using 60 sets of numbers and 3 numbers per set for a total of 180 patients, keeping each number in a set to remain unique and without sorting the numbers that are generated. (http://www.randomizer.org/). The remifentanil or placebo solutions as well as the nasal fentanyl or placebo spray are prepared and administered by an independent investigator who is aware of the group randomization and indicated interventions.

Group 1: Receive remifentanil i.v infusion 1 ml/10 kg/h (10 μg/ml) starting 5 minutes before propofol administration and continued throughout the procedure. At the same time intranasal normal saline is given. A bolus dose of propofol 1 mg/kg is followed by propofol infusion and the infusion is titrated to obtain BIS values around 40-70.

Group 2: Receive normal saline i.v. infusion in volume equal to the volume of remifentanil as if he/she were assigned to Group 1, intranasal fentanyl 200 μg, and propofol as in group 1.

Group 3: Receive i.v. normal saline infusion in volume equal to the volume of remifentanil as if he/she were assigned to Group 1, intranasal normal saline, and propofol as in groups 1 and 2.

Anesthetic technique Before opioid/placebo/anesthetic administration all patients receive for 3-5 min 100% oxygen via a face mask from a wall oxygen source by means of a Mapleson C breathing system. Two venous catheters are inserted in peripheral veins and connected via extension tubes to two separate infusion pumps for remifentanil or placebo and for propofol infusion.

Basic monitoring includes pulse oximetry, non-invasive blood pressure (measured in the beginning and at the end of the procedure), heart rate, respiratory rate and ECG. Additional monitoring includes BIS, (BIS VIEW ™ Monitoring System, Aspect Medical Systems, Inc. One Upland Road Norwood, MA 02062 USA). All patients are preoxygenated with 100% oxygen via a face mask before anesthetic administration. During the procedure oxygen (9 l/min) is administered via a nasal catheter. Sedation/anesthesia is maintained with propofol bolus 1 mg/kg to begin with, plus infusion (5-9 mg/kg/h) by means of an electric pump to obtain BIS values around 40-70.

Intraoperative variables to be recorded Baseline values (before starting opioid/placebo) and every 3 min thereafter throughout the procedure BIS, SpO2, HR, RR, and Movement of the patient (Yes/No) are recorded and the propofol infusion is increased accordingly. Systolic and diastolic blood pressure is recorded in the beginning and at the end of the procedure (not to disturb the patient and change the level of consciousness, except for complications during the procedure like bleeding, apnea etc). Also events of desaturation (SpO2 below 90), episodes of apnea (apnea for > than 30s), and other adverse events are recorded. Systolic and diastolic blood pressure is recorded in the beginning and at the end of the procedure (not to disturb the patient and change the level of consciousness, except for complications during the procedure, like bleeding, apnea etc).

At the end of the procedure the total doses of propofol and remifentanil (or the volume of placebo) are recorded.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304342

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

No publications provided

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
Study First Received: February 24, 2011
Last Updated: August 2, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by 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
Fentanyl
Remifentanil
Propofol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on August 01, 2014