Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487988
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
Sponsor:
American University of Beirut Medical Center
Organization:
American University of Beirut Medical Center
Study Overview
Official Title:
Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
Status:
RECRUITING
Status Verified Date:
2024-09
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 goal of this clinical trial is to compare blood pressure and heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction Secondary objectives include comparing the time needed for intubation and the incidence of postoperative sore throat hoarseness and upper airway trauma in adults aging between 18 to 55 years scheduled for elective surgery under general anesthesia
The main question it aims to answer is
Does fiberoptic intubation cause less hemodynamic instability than direct oral intubation using opioid free anesthesia induction
The main question it aims to answer is
Does fiberoptic intubation cause less hemodynamic instability than direct oral intubation using opioid free anesthesia induction
Detailed Description:
Background Intubation has always been linked to a transient increase in blood pressure and heart rate that could be deleterious in elderly and hemodynamically unstable patients Fiberoptic intubation which is currently used for suspected difficult intubation could cause less marked rise in blood pressure and heart rate Furthermore opioid free anesthesia has gained popularity lately to avoid opioid adverse effects ranging from respiratory depression postoperative ileus sedation nausea vomiting and urinary retention
Specific aims The primary objective of this study is to compare blood pressure and heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction Secondary objectives include comparing the time needed for intubation and the incidence of postoperative sore throat hoarseness and upper airway trauma
Methods In this prospective randomized clinical trial 90 45 in each group adults aging between 18 to 55 years scheduled for elective surgery under general anesthesia will be recruited over 1 year of work Patients will be randomly allocated to 2 groups The direct conventional laryngoscopy group performed with N3 for females or N4 for males Macintosh laryngoscope blade and the fiberoptic guided intubation group
Significance Studies comparing hemodynamic stability using fiberoptic intubation versus direct oral intubation in opioid free anesthesia are limited The present study will assess whether fiberoptic intubation causes less hemodynamic instability than direct oral intubation in opioid free anesthesia induction which will benefit patients with normal airways
Specific aims The primary objective of this study is to compare blood pressure and heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction Secondary objectives include comparing the time needed for intubation and the incidence of postoperative sore throat hoarseness and upper airway trauma
Methods In this prospective randomized clinical trial 90 45 in each group adults aging between 18 to 55 years scheduled for elective surgery under general anesthesia will be recruited over 1 year of work Patients will be randomly allocated to 2 groups The direct conventional laryngoscopy group performed with N3 for females or N4 for males Macintosh laryngoscope blade and the fiberoptic guided intubation group
Significance Studies comparing hemodynamic stability using fiberoptic intubation versus direct oral intubation in opioid free anesthesia are limited The present study will assess whether fiberoptic intubation causes less hemodynamic instability than direct oral intubation in opioid free anesthesia induction which will benefit patients with normal airways
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