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Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI

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ClinicalTrials.gov Identifier: NCT02576600
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Pr Isabelle CONSTANT, Hôpital Armand Trousseau

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.

Condition or disease Intervention/treatment Phase
Pain Device: Videopupillometer Algiscan Other: Standard practice Drug: Propofol Drug: Remifentanil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption
Study Start Date : October 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PUPILLO
Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI
Device: Videopupillometer Algiscan
pupillary diameter measurement every five minutes per-operatively

Drug: Propofol
TCI

Drug: Remifentanil
TCI

Sham Comparator: STANDARD
peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI
Other: Standard practice
remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice

Drug: Propofol
TCI

Drug: Remifentanil
TCI




Primary Outcome Measures :
  1. peroperative remifentanil consumption in µg/kg/min [ Time Frame: duration of surgery ]

Secondary Outcome Measures :
  1. post-operative morphine requirements in mg/kg [ Time Frame: 24 hours ]
    includes initial morphine titration and subsequent PCA use

  2. peroperative propofol consumption in mg/kg/h [ Time Frame: duration of surgery ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II
  • Elective gynecological surgery
  • No ophtalmologic or neurologic disease
  • No chronic analgesic medication
  • Expected length of surgery 60 minutes minimum

Exclusion Criteria:

  • ophtalmologic or neurologic disease
  • chronic analgesic medication

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): NCT02576600


Locations
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France
Departement d'anesthesie Hopital Armand Trousseau
Paris, France, 75012
Sponsors and Collaborators
Pr Isabelle CONSTANT
Investigators
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Study Director: Isabelle Constant, MD-PHD Hôpital Armand Trousseau
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Responsible Party: Pr Isabelle CONSTANT, Professor Isabelle Constant, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier: NCT02576600    
Other Study ID Numbers: Anesthesie Trousseau 001
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents