Actively Recruiting
Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
Led by American University of Beirut Medical Center · Updated on 2025-12-19
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on adults aged 18 to 55 years who are scheduled for elective surgery under general anesthesia. It aims to compare how two different intubation methods—fiberoptic intubation and direct oral intubation—affect blood pressure and heart rate when opioid-free anesthesia is used. The study seeks to determine if fiberoptic intubation causes less instability in these vital signs compared to direct oral intubation, addressing concerns related to the cardiovascular response during anesthesia. Participants will be randomly assigned to one of two groups. One group will undergo direct conventional laryngoscopy using a Macintosh laryngoscope blade sized N3 for females or N4 for males. The other group will receive fiberoptic guided intubation. Both procedures will be performed under opioid-free anesthesia induction, and the study will measure not only blood pressure and heart rate but also the time taken for intubation and the occurrence of postoperative issues like sore throat, hoarseness, and upper airway trauma. During the study, researchers will monitor heart rate and blood pressure from baseline through five minutes after intubation. They will also record the time required for intubation between face mask removal and the first end-tidal carbon dioxide reading. After 24 hours, patients will be checked for sore throat and any airway trauma during intubation will be assessed. The trial is randomized and double-blind, aimed at providing detailed insight into hemodynamic stability associated with these two intubation techniques in opioid-free anesthesia.
CONDITIONS
Brief Title
Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA physical status I and II
- Age between 18 and 55 years old
- Scheduled for elective surgery under general anesthesia
You will not qualify if you...
- History of cardiovascular diseases
- History of lung disease
- Hypertension (blood pressure above 140/90)
- Use of medications that affect blood pressure or heart rate
- Morbid obesity (BMI over 30)
- Severe gastroesophageal reflux disease (GERD)
- Predicted difficult airway (short thyromental distance less than 6 cm, upper lip bite test grade III, Mallampati score above III)
- Neck instability
- Planned rapid sequence intubation
- Refusal to participate
- History of difficult intubation or ventilation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo intubation using either direct conventional laryngoscopy or fiberoptic guided intubation during opioid free anesthesia induction as part of their elective surgery.
1 visit (in-person)
Duration - 24 hours after surgery
Participants are monitored for postoperative sore throat, hoarseness, and upper airway trauma after the intubation procedure.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Christian Rouphael
Beirut, Lebanon
Actively Recruiting
Research Team
C
Christian Rouphael, MD
T
Thuraya HajAli, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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