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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

Page last updated: August 23, 2015

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