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Completed

NCT Number: NCT02576600

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videopupillometer Algiscan

Device

pupillary diameter measurement every five minutes per-operatively

Standard Practice

Other

remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice

Propofol

Drug

TCI

Remifentanil

Drug

TCI

Primary outcomes

  1. peroperative remifentanil consumption in µg/kg/min

    Time frame: duration of surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pr Isabelle CONSTANT

Other

Registry information

Official study title

Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Oct 15, 2015
Registry last updated
Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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