Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery (PHOENIX)

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.
 
ClinicalTrials.gov Identifier: NCT03166644
Recruitment Status : Unknown
Verified May 2017 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : May 25, 2017
Last Update Posted : July 26, 2017
Sponsor:
Collaborators:
Rennes University Hospital
University Hospital, Montpellier
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
To determine whether a treatment strategy targeting an individualized sufentanil administration based on the Analgesia Nociception Index (ANI) could reduce the total dose of sufentanil during major abdominal surgery, as compared with standard practice.

Condition or disease Intervention/treatment Phase
Major Abdominal Surgery Device: Analgesia Nociception Index (ANI)-guided sufentanil administration Not Applicable

Detailed Description:

Postoperative respiratory complications are the second most frequent complications after surgery, and a major burden in health care. Postoperative hypoxemia, which is one of the most meaningful factors associated with poor patient outcomes, is common after general anesthesia with rates as high as 30-50% in patients after abdominal surgery, even among those undergoing uneventful procedures.

Risk factors for early postoperative hypoxemia, whether modifiable or not, are mainly related to the patient condition, the surgical procedure and the intraoperative anesthesia management strategy, especially the detrimental effects resulting from potential residual effects of anesthetic agents. There is, to date, only limited data on the incidence of postoperative hypoxemia resulting from excessive intraoperative opioid administration.

The Analgesia Nociception Index (ANI) is a unit-less index ranging from 0 to 100 calculated from the instantaneous wavelet transform analysis of heart rate variability, which indirectly reflects the parasympathetic tone, with higher ANI values indicating a prominent parasympathetic tone. ANI is sensitive to nociception stimuli and has recently been proposed to evaluate the analgesia/nociception equilibrium. The few interventional studies that have investigated the ability of a protocol-driven intraoperative analgesia procedure to reduce postoperative pain have used mixed results. One recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates. In addition, to our knowledge, no study has investigated whether ANI monitoring can be used to improve postoperative outcome. Accordingly, to determine the impact of an ANI-guided individualized opioids administration on postoperative outcomes, a large multicenter randomized controlled trial is needed. However, before such a trial can take place, it is necessary to determine the feasibility in potential participating sites of successfully reducing intraoperative opioid consumption while reducing postoperative pain.

The purpose of this study was to examine the feasibility of undertaking such a trial. Our primary hypothesis is that individualizing sufentanil administration to target ANI values between 50 and 70 during major abdominal surgery could reduce the intraoperative dose of sufentanil, as compared with standard practice.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants receive an intervention throughout the protocol
Masking: Single (Participant)
Masking Description: Simple Blind : participants are unaware of the intervention assignment; investigators are aware.
Primary Purpose: Treatment
Official Title: Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Feasibility Trial.
Actual Study Start Date : July 4, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control Group
Patients with major abdominal surgery
Device: Analgesia Nociception Index (ANI)-guided sufentanil administration
One recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates.

Experimental: Intervention Group
Patients with standard practice
Device: Analgesia Nociception Index (ANI)-guided sufentanil administration
One recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates.




Primary Outcome Measures :
  1. Total dose of sufentanil administered during major abdominal surgery [ Time Frame: at day 0 ]

Secondary Outcome Measures :
  1. Percentage of time spent in the therapeutic target [ Time Frame: at day 0 ]
    (ANI between 50 and 70 for an energy between 0.05 and 2.5)

  2. Number of patients with early postoperative hypoxemia [ Time Frame: at 30 min, 1 hour, 2 hour and 3 hour after tracheal extubation ]
    (defined as SpO2 <94% in ambient air but responding to administration of oxygen by nasal cannula or facial mask)

  3. Number of patients with late postoperative hypoxemia [ Time Frame: at day 1 and 2 after surgery ]
    (defined as SpO2 <94% in ambient air but responding to administration of oxygen by nasal cannula or facial mask)

  4. Time to extubation [ Time Frame: at day 0 ]
  5. Need for postoperative oxygen therapy [ Time Frame: at day 0 ]
  6. Postoperative pain score [ Time Frame: at 30 min, 1 hour, 2 hour and 3 hour after extubation ]
    evaluated by a visual numeric scale (EVN) at rest and after exercise

  7. Postoperative pain score [ Time Frame: on postoperative Day 1 and Day 2 ]
    evaluated by a visual numeric scale (EVN) at rest and after exercise

  8. Total dose of morphine administered in postoperative care unit [ Time Frame: at day 1 ]
    PACU

  9. Duration of PACU stay [ Time Frame: at day 1 ]
    defined by the time interval to reach an Aldrete score of 9 or more after the end of sufentanil administration



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Elective major abdominal surgery
  • Estimated duration of surgery greater than 2 hours

Exclusion Criteria:

  • Emergency abdominal surgery
  • Atrial fibrillation
  • Patient with pacemaker
  • Patient with heart transplant
  • Chronic beta-blockade
  • Intrathecal anesthesia
  • Conditions affecting SpO2 measurement (e.g., methemoglobinemia)
  • Morbid obesity (BMI> 35 kg/m2)
  • Obstructive sleep apnea (OSA)
  • Person under legal guardianship or curatorship
  • No affiliation with the French health care system
  • Pregnant or breastfeeding women
  • Refusal to participate or inability to provide informed consent

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): NCT03166644


Contacts
Layout table for location contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Emmanuel FUTIER         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Rennes University Hospital
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Emmanuel FUTIER University Hospital, Clermont-Ferrand
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03166644    
Other Study ID Numbers: CHU-335
2016-001603-23 ( Other Identifier: 2016-001603-23 )
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: May 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Analgesia Nociception Index (ANI)
Postoperative Analgesia
Postoperative Hypoxemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics