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

Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Feasibility Trial.

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.

Study Overview

• Status: Completed
• Conditions: Major Abdominal Surgery
• Intervention / Treatment: Device: Analgesia Nociception Index (ANI)-guided sufentanil administration

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total dose of sufentanil administered during major abdominal surgery	at day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time spent in the therapeutic target	(ANI between 50 and 70 for an energy between 0.05 and 2.5)	at day 0
Number of patients with early postoperative hypoxemia	(defined as SpO2 <94% in ambient air but responding to administration of oxygen by nasal cannula or facial mask)	at 30 min, 1 hour, 2 hour and 3 hour after tracheal extubation
Number of patients with late postoperative hypoxemia	(defined as SpO2 <94% in ambient air but responding to administration of oxygen by nasal cannula or facial mask)	at day 1 and 2 after surgery
Time to extubation		at day 0
Need for postoperative oxygen therapy		at day 0
Postoperative pain score	evaluated by a visual numeric scale (EVN) at rest and after exercise	at 30 min, 1 hour, 2 hour and 3 hour after extubation
Postoperative pain score	evaluated by a visual numeric scale (EVN) at rest and after exercise	on postoperative Day 1 and Day 2
Total dose of morphine administered in postoperative care unit	PACU	at day 1
Duration of PACU stay	defined by the time interval to reach an Aldrete score of 9 or more after the end of sufentanil administration	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: University Hospital, Montpellier; Rennes University Hospital
• Investigators: Principal Investigator: Emmanuel FUTIER, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2017
• Primary Completion (Actual): January 20, 2019
• Study Completion (Actual): January 20, 2019

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Postoperative Analgesia; Analgesia Nociception Index (ANI); Postoperative Hypoxemia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil
• Other Study ID Numbers: CHU-335; 2016-001603-23 (Other Identifier: 2016-001603-23)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No