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Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT02116868
Recruitment Status : Completed
First Posted : April 17, 2014
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Scheduled Laparoscopic Surgery Device: Pupillometry guided analgesia (PP) Drug: Tailored remifentanil controlled infusion Drug: Tailored antihypertensive drug administration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Usefulness of Pupillary Reflex on Remifentanil and Morphine Consumption During Laparoscopic Surgery. A Bicentric, Prospective, Randomized, Controlled Trial.
Study Start Date : March 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : April 2018

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Arms and Interventions
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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:
  • Traget controlled infusion
  • TCI

Drug: Tailored antihypertensive drug administration
Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex.
Other Names:
  • Esmolol
  • Nicardipine
  • Urapidil
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.


Outcome Measures
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Primary Outcome Measures :
  1. Peroperative Remifentanil consumption [ Time Frame: From the start of anesthesia to the end of surgery (<10 hours) ]

Secondary Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116868


Locations
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France
Maternité Régionale Universitaire (MRU)
Nancy, Lorraine, France, 54000
Centre Hospitalier Universitaire, Brabois
Nancy, Lorraine, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Study Chair: Claude MEISTELMAN, MD., PhD. Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
Principal Investigator: Philippe GUERCI, MD Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
Principal Investigator: Florence VIAL, MD Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Study Chair: Hervé BOUAZIZ, MD., PhD. Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02116868    
Other Study ID Numbers: 2013-A01002-43
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by Central Hospital, Nancy, France:
Pupillometry
Pupillary reflex
Analgesia
 Laparoscopic surgery
Total intravenous anesthesia
Target controlled infusion
Additional relevant MeSH terms:
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Antihypertensive Agents
Nicardipine
Urapidil
Remifentanil
Esmolol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Serotonin Receptor Agonists
Serotonin Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists