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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Standard practice; Device: Videopupillometer Algiscan; Drug: Propofol; Drug: Remifentanil

• Registration Number: NCT02576600
• Lead Sponsor: Pr Isabelle CONSTANT

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Status Verified: 2015-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STANDARD	Standard practice	peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI
PUPILLO	Videopupillometer Algiscan	Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI
PUPILLO	Propofol	Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI
STANDARD	Remifentanil	peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI
PUPILLO	Remifentanil	Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI
STANDARD	Propofol	peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI

Primary Outcome Measures

Name	Time	Method
peroperative remifentanil consumption in µg/kg/min	duration of surgery

Secondary Outcome Measures

Name	Time	Method
peroperative propofol consumption in mg/kg/h	duration of surgery
post-operative morphine requirements in mg/kg	24 hours	includes initial morphine titration and subsequent PCA use

Trial Locations

Locations (1)

Departement d'anesthesie Hopital Armand Trousseau; 🇫🇷 Paris, France