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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Major Abdominal Surgery

Intervention / Treatment
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* Device: Analgesia Nociception Index (ANI)-guided sufentanil administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants receive an intervention throughout the protocol
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia Nociception Index (ANI), Postoperative Analgesia, Postoperative Hypoxemia