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

Pain Clinical Trial

Official title:

Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576600
• Other study ID #: Anesthesie Trousseau 001
• Status: Completed
• Phase: N/A
• First received: October 13, 2015
• Last updated: October 16, 2015
• Start date: October 2010
• Est. completion date: April 2013

Study information

• Verified date: October 2015
• Source: Hôpital Armand Trousseau
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Videopupillometer Algiscan
pupillary diameter measurement every five minutes per-operatively

Other:
• Standard practice
remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice

Drug:
• Propofol
TCI
• Remifentanil
TCI

Locations

Country	Name	City	State
France	Departement d'anesthesie Hopital Armand Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pr Isabelle CONSTANT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peroperative remifentanil consumption in µg/kg/min		duration of surgery	No
Secondary	post-operative morphine requirements in mg/kg	includes initial morphine titration and subsequent PCA use	24 hours	No
Secondary	peroperative propofol consumption in mg/kg/h		duration of surgery	No