Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Scheduled Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pupillometry guided analgesia (PP)

Intervention Type DEVICE

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.

Tailored remifentanil controlled infusion

Intervention Type DRUG

The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed

Tailored antihypertensive drug administration

Intervention Type DRUG

Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Tailored remifentanil controlled infusion

The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed

Intervention Type DRUG

Tailored antihypertensive drug administration

Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex.

Intervention Type DRUG

Other Intervention Names

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Algiscan Neurolight Pupillometer Traget controlled infusion TCI Esmolol Nicardipine Urapidil

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No