Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery
Information source: Central Hospital, Nancy, France
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Scheduled Laparoscopic Surgery
Intervention: Pupillometry guided analgesia (PP) (Device); Tailored remifentanil controlled infusion (Drug); Tailored antihypertensive drug administration (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Central Hospital, Nancy, France Official(s) and/or principal investigator(s):
Claude MEISTELMAN, MD., PhD., Study Chair, Affiliation: Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
Philippe GUERCI, MD, Principal Investigator, Affiliation: Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
Florence VIAL, MD, Principal Investigator, Affiliation: Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Hervé BOUAZIZ, MD., PhD., Study Chair, Affiliation: Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE
Overall contact:
Philippe GUERCI, MD., Phone: +33 3 83 15 73 99, Email: p.guerci@chu-nancy.fr
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.
Clinical Details
Official title: Usefulness of Pupillary Reflex on Remifentanil and Morphine Consumption During Laparoscopic Surgery. A Bicentric, Prospective, Randomized, Controlled Trial.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Peroperative Remifentanil consumption
Secondary outcome: Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...)Use of antihypertensive agents or vasopressors Volume of fluid replacement Pain scores Incidence of postoperative nausea and vomiting (PONV) Time from extubation between the end of surgery and PACU admission Length of stay in PACU Immediate postoperative morphine consumption
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Philippe GUERCI, MD., Phone: +33 3 83 15 73 99, Email: p.guerci@chu-nancy.fr
Centre Hospitalier Universitaire, Brabois, Nancy, Lorraine 54500, France; Recruiting
Philippe GUERCI, MD., Phone: +33 3 83 15 73 99, Email: p.guerci@gmail.com
Denis SCHMARTZ, MD., Phone: +33 3 83 15 74 82, Email: d.schmartz@chu-nancy.fr
Philippe GUERCI, MD., Principal Investigator
Denis SCHMARTZ, MD., Sub-Investigator
Maternité Régionale Universitaire (MRU), Nancy, Lorraine 54000, France; Recruiting
Florence VIAL, MD., Phone: +33 3 83 34 44 67, Email: f.vial@maternite.chu-nancy.fr
Hervé BOUAZIZ, MD., PhD., Phone: +33 3 83 34 44 67, Email: h.bouaziz@chu-nancy.fr
Florence VIAL, MD., Principal Investigator
Delphine HERBAIN, MD., Sub-Investigator
Additional Information
Starting date: March 2014
Last updated: April 8, 2015
|
