Clinical trial NCT06487988: Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
Official title: Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesics, Opioid
Anesthesia, General
Heart Rate
Blood Pressure
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart rate
timeFrame: baseline and up to 5 mins upon intubation
measure: Blood pressure
timeFrame: baseline and up to 5 mins upon intubation
Secondary outcomes:
measure: time needed for intubation
timeFrame: between face mask removal and first ETCO2 reading in minutes
measure: incidence of postoperative sore throat
timeFrame: after 24 hrs
measure: incidence of upper airway trauma
timeFrame: during intubation
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Christian Rouphael
Study officials:
affiliation: American University of Beirut Medical Center
name: Christian Rouphael, MD
role: PRINCIPAL_INVESTIGATOR
References: