Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04594382
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2020-10-13
Brief Title:
Monitoring Pupillary Reflex Dilatation for Optimized Postoperative Opioid Delivery Before Extubation
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Monitoring Pupillary Reflex Dilatation for Optimized Postoperative Opioid Delivery Before Extubation A Randomized Pupillometry Study
Status:
COMPLETED
Status Verified Date:
2023-08
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 study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy conducted immediately at the end of surgery before extubation on total postoperative opioid consumption during the first 2 postoperative hours after elective ear nose throat ENT surgery
Detailed Description:
Pupillometric pain measurements helps clinicians determine and administer the optimized amount of opioids and so avoids opioid-induced side effectsThe study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy conducted before extubation on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery
Background The evaluation of pain intensity during the immediate postoperative period in the operating room OR is a key factor for post interventional pain treatment However this evaluation may be difficult when patients are still intubated restricted in consciousness or are showing verbal impairment due to ENT surgery Verbally impaired patients are at increased risk of under treatment for pain
With rising opioid consumption the risk of postoperative side effects like nausea and vomiting sedation with a longer recovery time or respiratory depression increases Especially in the cohort of ENT surgery patients where a difficult airway is regularly presented such side effects should be avoided A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable
The pupillary dilatation reflex PDR measured by pupillometry has been successfully used to assess intraoperative analgesic component of anesthetic regimes and correlates with pain intensity measured on a numeric rating scale NRS
Aims
Primary aim of this study is to investigate if a pupillometry-guided opioid administration immediately postoperative in the OR leads to less opioid requirement during the first 2 postoperative hours compared to a non-pupillometry-guided treatment
Secondary aim is to evaluate postoperative pain intensity during the first 2 postoperative hours in patients after pupillometry-guided versus non-pupillometry -guided opioid therapy in the OR
Hypotheses
The investigators hypothesis that through a targeted pain therapy based on the measurement of immediate postoperative pupillometry scores opioid consumption and pain intensity can be reduced during the first 2 postoperative hours
Methods
The study will be done by observing postoperative pain intensity using pupillometry in patients scheduled for elective ENT surgery carrying out pain intervention opioid therapy and re-observing to verify the effectiveness of the targeted postoperative opioid administration in the OR Pain on an 11-point verbal Likert response score and total opioid consumption will be recorded by a blinded investigator at 30-minute intervals for the initial 2 postoperative hours
Background The evaluation of pain intensity during the immediate postoperative period in the operating room OR is a key factor for post interventional pain treatment However this evaluation may be difficult when patients are still intubated restricted in consciousness or are showing verbal impairment due to ENT surgery Verbally impaired patients are at increased risk of under treatment for pain
With rising opioid consumption the risk of postoperative side effects like nausea and vomiting sedation with a longer recovery time or respiratory depression increases Especially in the cohort of ENT surgery patients where a difficult airway is regularly presented such side effects should be avoided A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable
The pupillary dilatation reflex PDR measured by pupillometry has been successfully used to assess intraoperative analgesic component of anesthetic regimes and correlates with pain intensity measured on a numeric rating scale NRS
Aims
Primary aim of this study is to investigate if a pupillometry-guided opioid administration immediately postoperative in the OR leads to less opioid requirement during the first 2 postoperative hours compared to a non-pupillometry-guided treatment
Secondary aim is to evaluate postoperative pain intensity during the first 2 postoperative hours in patients after pupillometry-guided versus non-pupillometry -guided opioid therapy in the OR
Hypotheses
The investigators hypothesis that through a targeted pain therapy based on the measurement of immediate postoperative pupillometry scores opioid consumption and pain intensity can be reduced during the first 2 postoperative hours
Methods
The study will be done by observing postoperative pain intensity using pupillometry in patients scheduled for elective ENT surgery carrying out pain intervention opioid therapy and re-observing to verify the effectiveness of the targeted postoperative opioid administration in the OR Pain on an 11-point verbal Likert response score and total opioid consumption will be recorded by a blinded investigator at 30-minute intervals for the initial 2 postoperative hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None