Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery

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

Tracking Information

• First Submitted Date: April 10, 2014
• First Posted Date: April 17, 2014
• Last Update Posted Date: November 1, 2019
• Study Start Date: March 2014
• Actual Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 15, 2014): Peroperative Remifentanil consumption [ Time Frame: From the start of anesthesia to the end of surgery (<10 hours) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 15, 2014)

• Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...) [ Time Frame: 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) ]
• Volume of fluid replacement [ Time Frame: 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
• Incidence of postoperative nausea and vomiting (PONV) [ Time Frame: 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) ]
• Length of stay in PACU [ Time Frame: 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) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery
• Official Title: Usefulness of Pupillary Reflex on Remifentanil and Morphine Consumption During Laparoscopic Surgery. A Bicentric, Prospective, Randomized, Controlled Trial.
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Scheduled Laparoscopic Surgery

Intervention

• 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

Study Arms

• 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.
  Interventions:

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

• Publications *: Guerci P, Jay G, Arnout C, Herbain D, Baka N, Poirel O, Novy E, Bouaziz H, Vial F. Effects of pupillary reflex dilation-guided opioid administration on remifentanil and morphine consumption during laparoscopic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Sep 1;38(9):975-984. doi: 10.1097/EJA.0000000000001491.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 15, 2014): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2018
• Actual Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02116868
• Other Study ID Numbers: 2013-A01002-43
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Central Hospital, Nancy, France
• Original Responsible Party: Same as current
• Current Study Sponsor: Central Hospital, Nancy, France
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Central Hospital, Nancy, France
• Verification Date: October 2019