Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
NCT ID: NCT06487988
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2024-09-11
2026-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The direct conventional laryngoscopy group
The direct conventional laryngoscopy group will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.
direct conventional laryngoscopy
direct conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.
The fiberoptic guided intubation group
The fiberoptic guided intubation will be performed.
fiberoptic guided intubation
fiberoptic guided intubation will be performed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
direct conventional laryngoscopy
direct conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.
fiberoptic guided intubation
fiberoptic guided intubation will be performed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Range age of 18-55 years' old
* Scheduled for elective surgery under general anesthesia.
Exclusion Criteria
* History of lung disease.
* Hypertensive patient (BP\> 140/90)
* Patient taking medications that affect blood pressure and heart rate
* Morbid obesity (BMI \>30)
* Severe GERD
* Predicted difficult airway (Short TMD \<6 cm, Upper li bite test grade III, Mallampati score
\>III)
* Neck instability
* Patient planned to receive rapid sequence intubation
* Patient refusal to participate
* History of difficult intubation/ ventilation
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
American University of Beirut Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christian Rouphael
Clinical Instructor of Anesthesia
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christian Rouphael, MD
Role: PRINCIPAL_INVESTIGATOR
American University of Beirut Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Christian Rouphael
Beirut, , Lebanon
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Christian Rouphael, M.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIO-2023-0271
Identifier Type: -
Identifier Source: org_study_id