Scheduled Laparoscopic Surgery
Conditions
Keywords
Pupillometry, Pupillary reflex, Analgesia, Laparoscopic surgery, Total intravenous anesthesia, Target controlled infusion
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.
Interventions
DEVICEPupillometry 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.
DRUGTailored remifentanil controlled infusion
The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed
DRUGTailored antihypertensive drug administration
Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex.
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peroperative Remifentanil consumption | From the start of anesthesia to the end of surgery (<10 hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of antihypertensive agents or vasopressors | From the start of anesthesia to the end of surgery (<10 hours) | — |
| Volume of fluid replacement | From the start of anesthesia to the end of surgery (<10 hours) | — |
| Pain scores | In the immediate postoperative period (<4 hours) | Using verbal rating scale |
| Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...) | From the start of anesthesia to the end of surgery (<10 hours) | — |
| Time from extubation between the end of surgery and PACU admission | In the immediate postoperative period (<4 hours) | — |
| Length of stay in PACU | From PACU admission to an ALDRETE score of 10 (< 4 hours) | — |
| Immediate postoperative morphine consumption | During postanesthetic care unit (PACU) stay (<4 hours) | — |
| Incidence of postoperative nausea and vomiting (PONV) | In the immediate postoperative period (<4 hours) | — |
Countries
France
Outcome results
None listed