Analgesics, OpioidNCT06487988
Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
A study testing direct conventional laryngoscopy and fiberoptic guided intubation in people with Analgesics, Opioid and Anesthesia, General, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The goal of this clinical trial is to compare heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction. Secondary objectives include comparing blood ressure, oxygen saturation, time needed for intubation and the incidence of postoperative sore throat, hoarseness, and upper… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesics, Opioid, Anesthesia, General, Heart Rate
- What is being tested?
- direct conventional laryngoscopy and fiberoptic guided intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteLebanon
- Study dates
- 11 Sep 2024to 9 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA (American Society of Anesthesiologists) physical status I and II
- Range age of 18-55 years' old
- Scheduled for elective surgery under general anesthesia.
Who cannot join
- 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 >40)
- Severe GERD
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction. Secondary objectives include comparing blood ressure, oxygen saturation, 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?
Read the 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, 68 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.
- Conditions
- Analgesics, Opioid, Anesthesia, General, Heart Rate, Blood Pressure
- Being tested
- direct conventional laryngoscopy, fiberoptic guided intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct conventional laryngoscopyDevice
direct conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.
fiberoptic guided intubationDevice
fiberoptic guided intubation will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: direct conventional laryngoscopy |
| The fiberoptic guided intubation group | Experimental | The fiberoptic guided intubation will be performed. Receives: Device: fiberoptic guided intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate (bpm)
Measured: baseline and up to 5 mins upon intubation
Secondary outcomes (5)
time needed for intubation
time (between face mask removal and first ETCO2 reading in minutes)
Measured: between face mask removal and first ETCO2 reading in minutes
incidence of postoperative sore throat
Sore throat pain (0-10)
Measured: after 24 hrs
incidence of upper airway trauma
incidence of upper airway trauma (Yes or No)
Measured: during intubation
Blood pressure
Blood pressure (mm Hg)
Measured: baseline and up to 5 mins upon intubation
Oxygen saturation
Oxygen saturation (SpO2%)
Measured: baseline and up to 5 mins upon intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start11 Sep 2024
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesics, OpioidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Rouphael, American University of Beirut Medical Center
- Investigators
- Christian Rouphael, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487988
- Sponsor's protocol ID
- BIO-2023-0271
- Status last verified
- Oct 2026
- First submitted
- 28 Jun 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
- ClinicalTrials.gov ID
- NCT06487988
- Acronym / sponsor ID
- BIO-2023-0271
- Conditions
- Analgesics, Opioid, Anesthesia, General, Heart Rate, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction. Secondary objectives include comparing blood ressure, oxygen saturation, 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, 68 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The direct conventional laryngoscopy group | Active comparator | Device: direct conventional laryngoscopyThe direct conventional laryngoscopy group will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade. |
| The fiberoptic guided intubation group | Experimental | Device: fiberoptic guided intubationThe fiberoptic guided intubation will be performed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA (American Society of Anesthesiologists) physical status I and II
- Range age of 18-55 years' old
- Scheduled for elective surgery under general anesthesia.
Key exclusion criteria (12 listed)
- 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 >40)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct conventional laryngoscopydirect conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade. | Device | The direct conventional laryngoscopy group |
| fiberoptic guided intubationfiberoptic guided intubation will be performed. | Device | The fiberoptic guided intubation group |
Primary outcome
Heart rate
Time frame: baseline and up to 5 mins upon intubation
Heart rate (bpm)
5 secondary outcomes
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
Blood pressure
Time frame: baseline and up to 5 mins upon intubation
Oxygen saturation
Time frame: baseline and up to 5 mins upon intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Rouphael, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct conventional laryngoscopy and fiberoptic guided intubation in people with Analgesics, Opioid and Anesthesia, General, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: baseline and up to 5 mins upon intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.