Clinical trial NCT02116868: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scheduled Laparoscopic Surgery
Keywords: Pupillometry
Pupillary reflex
Analgesia
Laparoscopic surgery
Total intravenous anesthesia
Target controlled infusion
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peroperative Remifentanil consumption
timeFrame: From the start of anesthesia to the end of surgery (<10 hours)
Secondary outcomes:
measure: Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...)
timeFrame: From the start of anesthesia to the end of surgery (<10 hours)
measure: Use of antihypertensive agents or vasopressors
timeFrame: From the start of anesthesia to the end of surgery (<10 hours)
measure: Volume of fluid replacement
timeFrame: From the start of anesthesia to the end of surgery (<10 hours)
measure: Pain scores
timeFrame: In the immediate postoperative period (<4 hours)
measure: Incidence of postoperative nausea and vomiting (PONV)
timeFrame: In the immediate postoperative period (<4 hours)
measure: Time from extubation between the end of surgery and PACU admission
timeFrame: In the immediate postoperative period (<4 hours)
measure: Length of stay in PACU
timeFrame: From PACU admission to an ALDRETE score of 10 (< 4 hours)
measure: Immediate postoperative morphine consumption
timeFrame: During postanesthetic care unit (PACU) stay (<4 hours)
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternité Régionale Universitaire (MRU)
state: Lorraine
city: Nancy
country: France
facility: Centre Hospitalier Universitaire, Brabois
state: Lorraine
Study officials:
affiliation: Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
name: Claude MEISTELMAN, MD., PhD.
role: STUDY_CHAIR
affiliation: Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
name: Philippe GUERCI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
name: Florence VIAL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE
name: Hervé BOUAZIZ, MD., PhD.
role: STUDY_CHAIR
References:
citation: 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.