Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery

Central Hospital, Nancy, France

Status: Completed

Conditions: Scheduled Laparoscopic Surgery

Treatments: Device: Pupillometry guided analgesia (PP); Drug: Tailored remifentanil controlled infusion; Drug: Tailored antihypertensive drug administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02116868

2013-A01002-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pupillometry guided analgesia (PP)

Experimental group

Description:

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.

Treatment:

Drug: Tailored antihypertensive drug administration

Drug: Tailored remifentanil controlled infusion

Device: Pupillometry guided analgesia (PP)

Standard practice (ST)

No Intervention group

Description:

Anesthesia and analgesia is left to the discretion of the anesthesiologist in charge. The anesthesiologist is blinded to the results of pupillometry.