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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| The fiberoptic guided intubation group | Experimental | The fiberoptic guided intubation will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| direct conventional laryngoscopy | Device | direct conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade. |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Rouphael, MD | Contact | 01 350 000 | 6820 | cr30@aub.edu.lb |
| Thuraya HajAli, MSc | Contact | 01 350 000 | 5738 | th64@aub.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Christian Rouphael, MD | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christian Rouphael | Recruiting | Beirut | Lebanon |
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| fiberoptic guided intubation | Device | fiberoptic guided intubation will be performed. |
|
Sore throat pain (0-10)
| after 24 hrs |
| incidence of upper airway trauma | incidence of upper airway trauma (Yes or No) | during intubation |