Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: direct conventional laryngoscopy, fiberoptic guided intubation.
- Who it may be relevant to
- Registry conditions: Analgesics, Opioid, Anesthesia, General, Heart Rate, Blood Pressure. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lebanon
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device direct conventional laryngoscopy
direct conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade. - Device fiberoptic guided intubation
fiberoptic guided intubation will be performed.
Primary outcome measures
- Heart rate [Time frame: baseline and up to 5 mins upon intubation]
- Blood pressure [Time frame: baseline and up to 5 mins upon intubation]
Secondary outcome measures (3)
- time needed for intubation [Time frame: between face mask removal and first ETCO2 reading in minutes]
- incidence of postoperative sore throat [Time frame: after 24 hrs]
- incidence of upper airway trauma [Time frame: during intubation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Lebanon · 1 center
- Christian Rouphael — Beirut
Identifiers
NCT: NCT06487988 · BIO-2023-0271