Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery

October 30, 2019 updated by: Central Hospital, Nancy, France

Usefulness of Pupillary Reflex on Remifentanil and Morphine Consumption During Laparoscopic Surgery. A Bicentric, Prospective, Randomized, Controlled Trial.

The purpose of this study is to determine whether analgesia guided by pupillary reflex during laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and postoperative morphine).This is a prospective, randomized, controlled study performed in two centers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For now, intraoperative analgesia remains hard to assess in the absence of reliable and validated analgesia monitor. The analysis of pupillary reflex is a new tool to assess analgesia during the intraoperative and postoperative period.

During laparoscopic surgery, carbon dioxide insufflation that produce pneumoperitoneum may induce hemodynamics events such as tachycardia or hypertension. These events may be misleading or confusing. Actually, these events are mainly considered as insufficient analgesia. Thus, anesthesiologists deepen analgesia and/or anesthesia by increasing concentration of anesthetics or opioids. These inappropriate actions may induce hypotension and/or bradycardia especially in elderly patients. On the contrary, insufficient analgesia may exist in hypovolemic patients or in patients with neuromuscular blocking agents.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Lorraine
      • Nancy, Lorraine, France, 54000
        • Maternité Régionale Universitaire (MRU)
      • Nancy, Lorraine, France, 54500
        • Centre Hospitalier Universitaire, Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists status 1 to 4
  • Scheduled laparoscopic surgery
  • Standardized anesthesia (TCI)
  • Social security affiliation

Exclusion Criteria:

  • Age < 18 yrs old
  • Emergency
  • BMI ≥ 35 kg.m-2
  • Refusal of consent
  • History of ocular pathology
  • Intake of: metoclopramide, droperidol, opioids or substitutive therapies
  • Patient with chronic pain
  • Neurologic impairments
  • Neuropathic pain
  • Drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pupillometry guided analgesia (PP)
Analgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided.
Device: Pupillometry guided analgesia (PP)
Analgesia is guided by pupillary reflex provided by the pupillometer (AlgiScan). The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed (Tailored remifentanil controlled infusion). Administration of antihypertensive drugs or vasopressors is also guided.
Other Names:
  • Algiscan Neurolight
  • Pupillometer
Drug: Tailored remifentanil controlled infusion
The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed
Other Names:
  • TCI
  • Traget controlled infusion
Drug: Tailored antihypertensive drug administration
Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex.
Other Names:
  • Urapidil
  • Esmolol
  • Nicardipine
No Intervention: Standard practice (ST)
Anesthesia and analgesia is left to the discretion of the anesthesiologist in charge. The anesthesiologist is blinded to the results of pupillometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peroperative Remifentanil consumption
Time Frame: From the start of anesthesia to the end of surgery (<10 hours)
From the start of anesthesia to the end of surgery (<10 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...)
Time Frame: From the start of anesthesia to the end of surgery (<10 hours)
From the start of anesthesia to the end of surgery (<10 hours)
Use of antihypertensive agents or vasopressors
Time Frame: From the start of anesthesia to the end of surgery (<10 hours)
From the start of anesthesia to the end of surgery (<10 hours)
Volume of fluid replacement
Time Frame: From the start of anesthesia to the end of surgery (<10 hours)
From the start of anesthesia to the end of surgery (<10 hours)
Pain scores
Time Frame: In the immediate postoperative period (<4 hours)
Using verbal rating scale
In the immediate postoperative period (<4 hours)
Incidence of postoperative nausea and vomiting (PONV)
Time Frame: In the immediate postoperative period (<4 hours)
In the immediate postoperative period (<4 hours)
Time from extubation between the end of surgery and PACU admission
Time Frame: In the immediate postoperative period (<4 hours)
In the immediate postoperative period (<4 hours)
Length of stay in PACU
Time Frame: From PACU admission to an ALDRETE score of 10 (< 4 hours)
From PACU admission to an ALDRETE score of 10 (< 4 hours)
Immediate postoperative morphine consumption
Time Frame: During postanesthetic care unit (PACU) stay (<4 hours)
During postanesthetic care unit (PACU) stay (<4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Chair: Hervé BOUAZIZ, MD., PhD., Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE
  • Principal Investigator: Philippe GUERCI, MD, Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
  • Study Chair: Claude MEISTELMAN, MD., PhD., Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
  • Principal Investigator: Florence VIAL, MD, Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 17, 2014

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01002-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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