Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery
NCT02116868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2019-11-01
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.
Conditions
- Scheduled Laparoscopic Surgery
Interventions
- 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.
- 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
- DRUG
-
Tailored antihypertensive drug administration
Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex.
Sponsors & Collaborators
-
Central Hospital, Nancy, France
lead OTHER
Principal Investigators
-
Claude MEISTELMAN, MD., PhD. · Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
-
Philippe GUERCI, MD · Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
-
Florence VIAL, MD · Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
-
Hervé BOUAZIZ, MD., PhD. · Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2018-03-31
- Completion
- 2018-04-30
Countries
- France
Study Locations
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