Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06487988

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?

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

direct conventional laryngoscopy

Device

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

fiberoptic guided intubation

Device

fiberoptic guided intubation will be performed.

Primary outcomes

  1. Heart rate

    Time frame: baseline and up to 5 mins upon intubation

    Heart rate (bpm)

  2. Blood pressure

    Time frame: baseline and up to 5 mins upon intubation

    Blood pressure (mm Hg)

Secondary outcomes

  1. time needed for intubation

    Time frame: between face mask removal and first ETCO2 reading in minutes

    time (between face mask removal and first ETCO2 reading in minutes)

  2. incidence of postoperative sore throat

    Time frame: after 24 hrs

    Sore throat pain (0-10)

  3. incidence of upper airway trauma

    Time frame: during intubation

    incidence of upper airway trauma (Yes or No)

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Rouphael, MD

CONTACT

[email protected]

01 350 000 ext. 6820

Thuraya HajAli, MSc

CONTACT

[email protected]

01 350 000 ext. 5738

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.