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

NCT06487988 | Recruiting

• 1 other identifier: BIO-2023-0271
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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?

Conditions

Heart Rate; Blood Pressure; Analgesics, Opioid; Anesthesia, General

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• time needed for intubation

  between face mask removal and first ETCO2 reading in minutes

• incidence of postoperative sore throat

  after 24 hrs

• incidence of upper airway trauma

  during intubation

Study Arms (2)

The direct conventional laryngoscopy group

ACTIVE COMPARATOR

The direct conventional laryngoscopy group will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.

Device: direct conventional laryngoscopy

The fiberoptic guided intubation group

EXPERIMENTAL

The fiberoptic guided intubation will be performed.

Device: fiberoptic guided intubation

Interventions

fiberoptic guided intubation DEVICE

fiberoptic guided intubation will be performed.

The fiberoptic guided intubation group

direct conventional laryngoscopy DEVICE

direct conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.

The direct conventional laryngoscopy group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

Christian Rouphael

Beirut, Lebanon

RECRUITING

Study Officials

• Christian Rouphael, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Rouphael, MD

CONTACT

01 350 000; cr30@aub.edu.lb

Thuraya HajAli, MSc

CONTACT

01 350 000; th64@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor of Anesthesia

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: September 11, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)