Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction

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?

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, General; Blood Pressure; Heart Rate; Analgesics, Opioid
• Intervention / Treatment: Device: direct conventional laryngoscopy; Device: fiberoptic guided intubation

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Rouphael, MD; Phone Number: 6820 01 350 000; Email: cr30@aub.edu.lb
• Study Contact Backup: Name: Thuraya HajAli, MSc; Phone Number: 5738 01 350 000; Email: th64@aub.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • Christian Rouphael
    • Contact: Christian Rouphael, M.D.; Phone Number: 6380 00-961-350-000; Email: cr30@aub.edu.lb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ASA (American Society of Anesthesiologists) physical status I and II
• Range age of 18-55 years' old
• Scheduled for elective surgery under general anesthesia.

Exclusion Criteria:

• History of cardiovascular diseases.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The direct conventional laryngoscopy group; The direct conventional laryngoscopy group will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.	Device: direct conventional laryngoscopy; direct conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.
Experimental: The fiberoptic guided intubation group; The fiberoptic guided intubation will be performed.	Device: fiberoptic guided intubation; fiberoptic guided intubation will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate (bpm)	baseline and up to 5 mins upon intubation
Blood pressure	Blood pressure (mm Hg)	baseline and up to 5 mins upon intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time needed for intubation	time (between face mask removal and first ETCO2 reading in minutes)	between face mask removal and first ETCO2 reading in minutes
incidence of postoperative sore throat	Sore throat pain (0-10)	after 24 hrs
incidence of upper airway trauma	incidence of upper airway trauma (Yes or No)	during intubation

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Christian Rouphael, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BIO-2023-0271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No