Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI
Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption
1 other identifier
interventional
65
1 country
1
Brief Summary
The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Oct 2010
Longer than P75 for not_applicable pain
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
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedOctober 19, 2015
October 1, 2015
2.2 years
October 13, 2015
October 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
peroperative remifentanil consumption in µg/kg/min
duration of surgery
Secondary Outcomes (2)
post-operative morphine requirements in mg/kg
24 hours
peroperative propofol consumption in mg/kg/h
duration of surgery
Study Arms (2)
PUPILLO
EXPERIMENTALVideopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI
STANDARD
SHAM COMPARATORperoperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI
Interventions
pupillary diameter measurement every five minutes per-operatively
remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice
Eligibility Criteria
You may qualify if:
- ASA I-II
- Elective gynecological surgery
- No ophtalmologic or neurologic disease
- No chronic analgesic medication
- Expected length of surgery 60 minutes minimum
You may not qualify if:
- ophtalmologic or neurologic disease
- chronic analgesic medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departement d'anesthesie Hopital Armand Trousseau
Paris, 75012, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Isabelle Constant, MD-PHD
Hôpital Armand Trousseau
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor Isabelle Constant
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 15, 2015
Study Start
October 1, 2010
Primary Completion
December 1, 2012
Study Completion
April 1, 2013
Last Updated
October 19, 2015
Record last verified: 2015-10