Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery
PHOENIX
2 other identifiers
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 25, 2017
CompletedStudy Start
First participant enrolled
July 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2019
CompletedOctober 16, 2023
August 1, 2019
1.5 years
May 23, 2017
October 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total dose of sufentanil administered during major abdominal surgery
at day 0
Secondary Outcomes (9)
Percentage of time spent in the therapeutic target
at day 0
Number of patients with early postoperative hypoxemia
at 30 min, 1 hour, 2 hour and 3 hour after tracheal extubation
Number of patients with late postoperative hypoxemia
at day 1 and 2 after surgery
Time to extubation
at day 0
Need for postoperative oxygen therapy
at day 0
- +4 more secondary outcomes
Study Arms (2)
Control Group
EXPERIMENTALPatients with major abdominal surgery
Intervention Group
EXPERIMENTALPatients with standard practice
Interventions
One recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates.
Eligibility Criteria
You may qualify if:
- Age \>18 years
- Elective major abdominal surgery
- Estimated duration of surgery greater than 2 hours
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- Rennes University Hospitalcollaborator
- University Hospital, Montpelliercollaborator
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003, France
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel FUTIER
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Simple Blind : participants are unaware of the intervention assignment; investigators are aware.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 25, 2017
Study Start
July 4, 2017
Primary Completion
January 20, 2019
Study Completion
January 20, 2019
Last Updated
October 16, 2023
Record last verified: 2019-08