Analgesics, Opioid, Anesthesia, General, Blood Pressure, Heart Rate
Conditions
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.
Interventions
DEVICEdirect conventional laryngoscopy
direct conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.
DEVICEfiberoptic guided intubation
fiberoptic guided intubation will be performed.
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | baseline and up to 5 mins upon intubation | Heart rate (bpm) |
| Blood pressure | baseline and up to 5 mins upon intubation | Blood pressure (mm Hg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| incidence of upper airway trauma | during intubation | incidence of upper airway trauma (Yes or No) |
Countries
Lebanon
Contacts
PRINCIPAL_INVESTIGATORChristian Rouphael, MD
American University of Beirut Medical Center
Outcome results
None listed