Intubation; Difficult or FailedRemiTrachNCT03744949
ED50 and ED95 of Remifentanil for Intubation Without NOL Variation
A study testing Remifentanil dose 0.5 ug/kg, Remifentanil dose 1 ug/kg and Remifentanil dose 1.5 ug/kg in people with Intubation; Difficult or Failed, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
Our aim, in this study, is to elucidate the optimal dosing range (ED50 and ED95) of bolus remifentanil in order to counter the painful stimuli resulting from direct laryngoscopy and tracheal intubation by using the NOL index. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Remifentanil dose 0.5 ug/kg, Remifentanil dose 1 ug/kg and Remifentanil dose 1.5 ug/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2018to 30 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status I or II
- Mallampati class I or II
- Patients > 18 years old and <65 years (defining elderly patients)
- Elective general, gynecological, orthopedic, plastic or urological surgery under general anesthesia
- Type of surgery that usually necessitate endotracheal intubation and controlled ventilation
Who cannot join
- Patient refusal
- History of psychiatric diseases or psychological problems (including mental retardation); inability to give consent; language barrier.
- Anticipated difficult airway (Mallampati class III and IV, thyromental distance < 6 cm, mouth opening < 3 cm, neck extension <80° and neck flexion <35°, inability to prognath, meaning bringing lower mandibular before the upper maxilla)
- Patient with history of neck rigidity or instability
- BMI > 30 kg/m2
- Anticipated difficult ventilation (patients with beard, obesity with BMI more than 30 kg/m2)
Show all 17Show fewer
- Patient with history of oropharyngeal or tracheal surgery (excluding adenoidectomy, tonsillectomy and teeth removal)
- Severe coronary artery disease
- Serious cardiac arrhythmias (including atrial fibrillation)
- Use of β-blockers (all types)
- History of opioid or illicit drug substance abuse
- Chronic use of psychotropic and/or opioid drugs
- Allergy to remifentanil or propofol
- Pregnancy
- Contraindications to mask ventilation (gastrointestinal tract obstruction, pregnancy, active not-treated gastroesophageal reflux disease, non-fasting patients)
- Unexpected difficult airway requesting excessive, possibly painful airway manipulations
- Requiring hemodynamic support with vasopressors or inotropes 2 min before laryngoscopy to 5 min after insertion of endotracheal tube
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the ED50 and ED95 of Remifentanil to Perform Tracheal Intubation Without Significant NOL Index Variation
Our aim, in this study, is to elucidate the optimal dosing range (ED50 and ED95) of bolus remifentanil in order to counter the painful stimuli resulting from direct laryngoscopy and tracheal intubation by using the NOL index. In order to maximize the clinical relevance of our findings, induction of general anesthesia will be done with standard medications and doses and laryngoscopy will be done with the Macintosh laryngoscope, the most common tool used for intubation in the operating room
Read the detailed description
Background: There are no study so far that determined the ED50 and ED95 of remifentanil to perform tracheal intubation by using the NOL index as the criterion measured to determine the failure (painful intubation) or the success (pain free intubation) of the assessed procedure.
Objectives: To determine the ED50 and ED95 of remifentanil bolus to perform tracheal intubation without NOL index variating over threshold for nociceptive response (determined as a NOL index going over 20 - peak value of maximum 20) using the Macintosh blade when obtaining good conditions of intubation in anesthetized patients. Good conditions of intubation will be determined as obtaining a Cormack-Lehane grade I and II.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Remifentanil dose 0.5 ug/kg, Remifentanil dose 1 ug/kg, Remifentanil dose 1.5 ug/kg, Remifentanil dose 2 ug/kg
- Keywords
- Tracheal intubation, Remifentanil, Pain, NOL index, Anesthesia, Analgesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil dose 0.5 ug/kgDrug
Remifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds
Remifentanil dose 1 ug/kgDrug
Remifentanil will be given (dosage of 1 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds
Remifentanil dose 1.5 ug/kgDrug
Remifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds
Remifentanil dose 2 ug/kgDrug
Remifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil dose 0.5 ug/kg | Experimental | Remifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. Receives: Drug: Remifentanil dose 0.5 ug/kg |
| Remifentnil dose 1 ug/kg | Experimental | Remifentanil will be given (dosage of 1.0 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. Receives: Drug: Remifentanil dose 1 ug/kg |
| Remifentanil dose 1.5 ug/kg | Experimental | Remifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. Receives: Drug: Remifentanil dose 1.5 ug/kg |
| Remifentanil dose 2 ug/kg | Experimental | Remifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. Receives: Drug: Remifentanil dose 2 ug/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine ED95 of remifentanil bolus in mcg/kg for tracheal intubation
The primary goal of this study is to determine the ED95 of remifentanil bolus to perform tracheal intubation without NOL index varying over 20 (peak maximal value of 20) using the Macintosh blade when obtaining a Cormack-Lehane grade I or II of intubation in anesthetized patients (the size of the blade will be chosen according to patient characteristics described in the user's manual for each blade and published in previous literature). This primary outcome will be expressed in mcg/kg of remifentanil.
Measured: in the surgery
Secondary outcomes (8)
NOL maximal value after intubation (NOL is an index without unit going from 0 to 100)
After tracheal intubation NOL index maximal value will be evaluated and compared between the 4 doses of remifentanil in mcg/kg received in this study.
Measured: in the surgery
Variation of NOL index after tracheal intubation; DELTA NOL (no unit)
After tracheal intubation DELTA NOL index will be evaluated and compared between the 4 doses of remifentanil in mcg/kg received in this study.
Measured: in the surgery
Time in seconds NOL spends above 25 after tracheal intubation (in seconds)
Time in seconds spent above 25 of NOL index and comparison between the 4 doses of remifentanil used in this study
Measured: in the surgery
Area under the curve for NOL index after tracheal intubation (no unit)
Compare the AUC of NOL after tracheal intubation between the 4 doses of remifentanil used in this study.
Measured: in the surgery
Heart Rate Maximal value after tracheal intubation (in beat per minutes)
To compare maximal heart rate values reached after tracheal intubation between the 4 doses of remifentanil used in this study
Measured: in the surgery
Heart Rate variation (DELTA Heart Rate) after tracheal intubation (in beats per minute)
To compare the DELTA Heart Rate after tracheal intubation between the 4 doses of remifentanil used in this study
Measured: in the surgery
Time in seconds that Heart Rate spends above threshold of 10%; in seconds
To compare the time in seconds between the 4 doses of remifentanil that Heart Rate spends above teh threshold of 10% of variation above normal prestimulus values.
Measured: in the surgery
Area under the curve of Heart Rate after tracheal intubation (no unit)
To compare AUC of Heart Rate values after tracheal intubation between teh 4 different doses of remifentanil used in this study.
Measured: in the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start14 Mar 2018
- Primary completion19 Oct 2018
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies 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
- Model description
- Four groups of patients. Randomization into the dose of remifentanil given according to a randomization list for a total number of patients of 80.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Philippe Richebe, MD PhD, Principal investigator, CIUSSS de l'Est de Montreal, Hopital Maisonneuve Rosemont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744949
- Sponsor's protocol ID
- 2018-1410
- Acronym
- RemiTrach
- Status last verified
- Oct 2021
- First submitted
- 11 Nov 2018
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the ED50 and ED95 of Remifentanil to Perform Tracheal Intubation Without Significant NOL Index Variation
- ClinicalTrials.gov ID
- NCT03744949
- Acronym / sponsor ID
- RemiTrach / 2018-1410
- Conditions
- Intubation; Difficult or Failed
- Keywords
- Tracheal intubation, Remifentanil, Pain, NOL index, Anesthesia, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 Nov 2018 (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.
Our aim, in this study, is to elucidate the optimal dosing range (ED50 and ED95) of bolus remifentanil in order to counter the painful stimuli resulting from direct laryngoscopy and tracheal intubation by using the NOL index. In order to maximize the clinical relevance of our findings, induction of general anesthesia will be done with standard medications and doses and laryngoscopy will be done with the Macintosh laryngoscope, the most common tool used for intubation in the operating room
Detailed description
Background: There are no study so far that determined the ED50 and ED95 of remifentanil to perform tracheal intubation by using the NOL index as the criterion measured to determine the failure (painful intubation) or the success (pain free intubation) of the assessed procedure.
Objectives: To determine the ED50 and ED95 of remifentanil bolus to perform tracheal intubation without NOL index variating over threshold for nociceptive response (determined as a NOL index going over 20 - peak value of maximum 20) using the Macintosh blade when obtaining good conditions of intubation in anesthetized patients. Good conditions of intubation will be determined as obtaining a Cormack-Lehane grade I and II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Four groups of patients. Randomization into the dose of remifentanil given according to a randomization list for a total number of patients of 80.
| Arm | Type | Receives |
|---|---|---|
| Remifentanil dose 0.5 ug/kg | Experimental | Drug: Remifentanil dose 0.5 ug/kgRemifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. |
| Remifentnil dose 1 ug/kg | Experimental | Drug: Remifentanil dose 1 ug/kgRemifentanil will be given (dosage of 1.0 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. |
| Remifentanil dose 1.5 ug/kg | Experimental | Drug: Remifentanil dose 1.5 ug/kgRemifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. |
| Remifentanil dose 2 ug/kg | Experimental | Drug: Remifentanil dose 2 ug/kgRemifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA status I or II
- Mallampati class I or II
- Patients > 18 years old and <65 years (defining elderly patients)
- Elective general, gynecological, orthopedic, plastic or urological surgery under general anesthesia
- Type of surgery that usually necessitate endotracheal intubation and controlled ventilation
Key exclusion criteria (17 listed)
- Patient refusal
- History of psychiatric diseases or psychological problems (including mental retardation); inability to give consent; language barrier.
- Anticipated difficult airway (Mallampati class III and IV, thyromental distance < 6 cm, mouth opening < 3 cm, neck extension <80° and neck flexion <35°, inability to prognath, meaning bringing lower mandibular before the upper maxilla)
- Patient with history of neck rigidity or instability
- BMI > 30 kg/m2
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 |
|---|---|---|
| Remifentanil dose 0.5 ug/kgRemifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds | Drug | Remifentanil dose 0.5 ug/kg |
| Remifentanil dose 1 ug/kgRemifentanil will be given (dosage of 1 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds | Drug | Remifentnil dose 1 ug/kg |
| Remifentanil dose 1.5 ug/kgRemifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds | Drug | Remifentanil dose 1.5 ug/kg |
| Remifentanil dose 2 ug/kgRemifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds | Drug | Remifentanil dose 2 ug/kg |
Primary outcome
determine ED95 of remifentanil bolus in mcg/kg for tracheal intubation
Time frame: in the surgery
The primary goal of this study is to determine the ED95 of remifentanil bolus to perform tracheal intubation without NOL index varying over 20 (peak maximal value of 20) using the Macintosh blade when obtaining a Cormack-Lehane grade I or II of intubation in anesthetized patients (the size of the blade will be chosen according to patient characteristics described in the user's manual for each blade and published in previous literature). This primary outcome will be expressed in mcg/kg of remifentanil.
8 secondary outcomes
NOL maximal value after intubation (NOL is an index without unit going from 0 to 100)
Time frame: in the surgery
Variation of NOL index after tracheal intubation; DELTA NOL (no unit)
Time frame: in the surgery
Time in seconds NOL spends above 25 after tracheal intubation (in seconds)
Time frame: in the surgery
Area under the curve for NOL index after tracheal intubation (no unit)
Time frame: in the surgery
Heart Rate Maximal value after tracheal intubation (in beat per minutes)
Time frame: in the surgery
Heart Rate variation (DELTA Heart Rate) after tracheal intubation (in beats per minute)
Time frame: in the surgery
Time in seconds that Heart Rate spends above threshold of 10%; in seconds
Time frame: in the surgery
Area under the curve of Heart Rate after tracheal intubation (no unit)
Time frame: in the surgery
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 4 Oct 2021.
- 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.
Philippe Richebe, MD PhD principal investigator
CIUSSS de l'Est de Montreal, Hopital Maisonneuve Rosemont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil dose 0.5 ug/kg, Remifentanil dose 1 ug/kg and Remifentanil dose 1.5 ug/kg in people with Intubation; Difficult or Failed, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 5 inclusion and 17 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 4 Oct 2021. 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 Canada. 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?
determine ED95 of remifentanil bolus in mcg/kg for tracheal intubation (time frame: in the surgery). 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 4 Oct 2021.