Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-27 @ 7:40 PM
Study NCT ID:
NCT02116868
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Usefulness of Pupillary Reflex on Remifentanil and Morphine Consumption During Laparoscopic Surgery. A Bicentric, Prospective, Randomized, Controlled Trial.
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: