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NCT Number: NCT02116868

Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery

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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Key information

Conditions

Scheduled Laparoscopic Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire, Brabois, Nancy, Lorraine, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pupillometry guided analgesia (PP)

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.

Other names: Algiscan Neurolight, Pupillometer

Tailored remifentanil controlled infusion

Drug

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

Other names: Traget controlled infusion, TCI

Tailored antihypertensive drug administration

Drug

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

Other names: Esmolol, Nicardipine, Urapidil

Primary outcomes

  1. Peroperative Remifentanil consumption

    Time frame: From the start of anesthesia to the end of surgery (<10 hours)

Secondary outcomes

  1. Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...)

    Time frame: From the start of anesthesia to the end of surgery (<10 hours)

  2. Use of antihypertensive agents or vasopressors

    Time frame: From the start of anesthesia to the end of surgery (<10 hours)

  3. Volume of fluid replacement

    Time frame: From the start of anesthesia to the end of surgery (<10 hours)

  4. Pain scores

    Time frame: In the immediate postoperative period (<4 hours)

    Using verbal rating scale

  5. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: In the immediate postoperative period (<4 hours)

  6. Time from extubation between the end of surgery and PACU admission

    Time frame: In the immediate postoperative period (<4 hours)

  7. Length of stay in PACU

    Time frame: From PACU admission to an ALDRETE score of 10 (< 4 hours)

  8. Immediate postoperative morphine consumption

    Time frame: During postanesthetic care unit (PACU) stay (<4 hours)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2014
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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