Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Scheduled Laparoscopic Surgery
• Interventions: Device: Pupillometry guided analgesia (PP); Drug: Tailored remifentanil controlled infusion; Drug: Tailored antihypertensive drug administration

• Registration Number: NCT02116868
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Primary Completion: 2018-03
• Study Completion: 2018-04
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pupillometry guided analgesia (PP)	Tailored remifentanil controlled infusion	Analgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided.
Pupillometry guided analgesia (PP)	Pupillometry guided analgesia (PP)	Analgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided.
Pupillometry guided analgesia (PP)	Tailored antihypertensive drug administration	Analgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided.

Primary Outcome Measures

Name	Time	Method
Peroperative Remifentanil consumption	From the start of anesthesia to the end of surgery (<10 hours)

Secondary Outcome Measures

Name	Time	Method
Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...)	From the start of anesthesia to the end of surgery (<10 hours)
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
Incidence of postoperative nausea and vomiting (PONV)	In the immediate postoperative period (<4 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)

Trial Locations

Locations (2)

Centre Hospitalier Universitaire, Brabois; 🇫🇷 Nancy, Lorraine, France

Maternité Régionale Universitaire (MRU); 🇫🇷 Nancy, Lorraine, France