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

Not Applicable

Not yet recruiting

• Conditions: Blood Pressure; Anesthesia, General; Analgesics, Opioid; Heart Rate
• Interventions: Device: fiberoptic guided intubation; Device: direct conventional laryngoscopy

• Registration Number: NCT06487988
• Lead Sponsor: American University of Beirut Medical Center

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?

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 Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23
• Study Start: 2024-09-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The fiberoptic guided intubation group	fiberoptic guided intubation	The fiberoptic guided intubation will be performed.
The direct conventional laryngoscopy group	direct conventional laryngoscopy	The direct conventional laryngoscopy group will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.

Primary Outcome Measures

Name	Time	Method
Blood pressure	baseline and up to 5 mins upon intubation	Blood pressure (mm Hg)
Heart rate	baseline and up to 5 mins upon intubation	Heart rate (bpm)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Christian Rouphael; 🇱🇧 Beirut, Lebanon