AnesthesiaPhase 4NCT03414879
Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation
A Phase 4 study testing Ketamine and Lidocaine in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Ketamine and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 25 Jul 2019
- Phase
- Phase 4
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I and II of both sexes with body weight from 60-90 kg, and planned for elective awake nasal fiberoptic intubation due to expected difficulty in airway management (e.g. limited mouth opening, trismus, mandibular/ maxillary swellings or tumors, ludwig's angina, or other indications).
Who cannot join
- body weight < 60 kg or > 90 kg
- uncooperative, with mental or psychological problems
- known allergy to any of the study drugs
- pregnancy
- hypertension
- cardiac disease
Show all 12Show fewer
- liver or renal impairment
- epilepsy,
- asthmatic,
- previous bad experience of awake intubation,
- emergency operations or
- coagulation abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine Versus Lidocaine Nebulization for Awake Nasal Fiberoptic Intubation: a Prospective, Randomized Double-blinded Study
This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
Read the detailed description
Difficult airway is one of the major challenges facing anesthesiologists. This challenge is compounded when the patient is treated while awake. The additional burden is to complete this procedure comfortably thus ensuring patient cooperation which is a vital part of successful performance. Several methods have been tried in literature to facilitate awake intubation by fiberoptic bronchoscope (FOB)
This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
- Conditions
- Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
While in the semi-setting position, patients will receive nebulization with ketamine 3 mg/kg to be completed with normal saline solution to reach a volume of 6 ml (K group; n=30) for 15 minutes before commencing the awake fiberoptic intubation..
LidocaineDrug
Also called xylocaine
While in the semi-setting position, patients will receive nebulization with lidocaine 4% 6 ml (L group; n=30) for 15 minutes before commencing the awake fiberoptic intubation
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | Active comparator | Nebulization with ketamine Receives: Drug: Ketamine |
| Lidocaine group | Active comparator | Nebulization with with lidocaine Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of supplemental lidocaine
Dose of supplemental lidocaine during awake fiberoptic procedure
Measured: Intraoperative
Secondary outcomes (3)
Incidence of adverse events
The incidence of adverse events related to the procedure and study drugs will be recorded
Measured: Intraoperative
Patient satisfaction score
will be assessed against five point Likert score where (1: poor, 2: fair, 3: good, 4: very good, 5: excellent).
Measured: first 24 hours
Patient tolerability score
Patient tolerability during the procedure will be rated as 4-point scale where 0= procedure totally intolerable with severe patient resistance (struggling/withdrawal movements).
- procedure partially tolerable with moderate patient resistance (restlessness/ verbal objection).
- procedure quiet tolerable with minimal patient resistance (just grimacing).
- procedure tolerable with no patient resistance. this score will be recorded at points during the intubation procedure: nasal passage, oro/hypopharynx, glottis and tube insertion.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start15 Jan 2018
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Ahmad Alsayed Abdellatif, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414879
- Sponsor's protocol ID
- FMASU R3/2018
- Status last verified
- Nov 2019
- First submitted
- 21 Jan 2018
- Last updated
- 26 Nov 2019
- Results posted
- 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 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Versus Lidocaine Nebulization for Awake Nasal Fiberoptic Intubation: a Prospective, Randomized Double-blinded Study
- ClinicalTrials.gov ID
- NCT03414879
- Acronym / sponsor ID
- FMASU R3/2018
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 30 Jan 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.
This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
Detailed description
Difficult airway is one of the major challenges facing anesthesiologists. This challenge is compounded when the patient is treated while awake. The additional burden is to complete this procedure comfortably thus ensuring patient cooperation which is a vital part of successful performance. Several methods have been tried in literature to facilitate awake intubation by fiberoptic bronchoscope (FOB)
This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine group | Active comparator | Drug: KetamineNebulization with ketamine |
| Lidocaine group | Active comparator | Drug: LidocaineNebulization with with lidocaine |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I and II of both sexes with body weight from 60-90 kg, and planned for elective awake nasal fiberoptic intubation due to expected difficulty in airway management (e.g. limited mouth opening, trismus, mandibular/ maxillary swellings or tumors, ludwig's angina, or other indications).
Key exclusion criteria (12 listed)
- body weight < 60 kg or > 90 kg
- uncooperative, with mental or psychological problems
- known allergy to any of the study drugs
- pregnancy
- hypertension
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 |
|---|---|---|
| KetamineAlso: KetalarWhile in the semi-setting position, patients will receive nebulization with ketamine 3 mg/kg to be completed with normal saline solution to reach a volume of 6 ml (K group; n=30) for 15 minutes before commencing the awake fiberoptic intubation.. | Drug | Ketamine group |
| LidocaineAlso: xylocaineWhile in the semi-setting position, patients will receive nebulization with lidocaine 4% 6 ml (L group; n=30) for 15 minutes before commencing the awake fiberoptic intubation | Drug | Lidocaine group |
Primary outcome
Dose of supplemental lidocaine
Time frame: Intraoperative
Dose of supplemental lidocaine during awake fiberoptic procedure
3 secondary outcomes
Incidence of adverse events
Time frame: Intraoperative
Patient satisfaction score
Time frame: first 24 hours
Patient tolerability score
Time frame: Intraoperative
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 26 Nov 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Lidocaine in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
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 1 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 26 Nov 2019. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dose of supplemental lidocaine (time frame: Intraoperative). 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 26 Nov 2019.