Postoperative ComplicationsNCT05614609
Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial
A study testing Lidocaine topical in people with Postoperative Complications and Intubation; Difficult or Failed, run by Ostfold University College at 1 site in Norway.
Trial summary
Few studies have compared different methods for optimalizing intubation conditions in general anesthesia. This randomized controlled trial will compare two different methods for intubation in general anesthesia in gastro- or gynecological procedures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Complications, Intubation; Difficult or Failed, Intubation Complication
- What is being tested?
- Lidocaine topical
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2023to 31 Jan 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (American Association of Anesthesiologists Classification system for physical status) I-III
- Understand and can express themselves in Norwegian
- Able to give informed consent to participate
Who cannot join
- Cave lidocain and/or muscle relaxing medication
- BMI above 40
- Anticipated difficult intubation
- Need for ventricular tube
- Pathology or malformations in upper airways
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial in a Norwegian Hospital
Few studies have compared different methods for optimalizing intubation conditions in general anesthesia. This randomized controlled trial will compare two different methods for intubation in general anesthesia in gastro- or gynecological procedures.
Read the detailed description
In general anesthesia, it is neccessary to secure the airways with an endotracheal tube. There is no international consensus on how intubation is most efficiently conducted. A cochrane review compared using muscular relaxing medication versus not using blocks for intubation. Primary outcomes were intubation conditions and discomfort in upper airways. The authors concluded that research is limited, and that further research is needed. No studies have compared local anesthetic spray on the glottis and muscular relaxing medication in intubation, focusing on discomfort in upper airways. The null-hypothesis of this study is that there is no difference in upper airway discomfort when using local anesthetic spray or muscular relaxing medication. The study will have a randomized controlled design, randomizing patients undergoing gastro- or gynecological procedures in general anesthesia to receiving either rocuronium (muscle relaxing medication) intravenous, or lidocain spray on the glottis before intubation. The primary outcome is postoperativ hoarseness one hour after intubation.
- Being tested
- Lidocaine topical
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine topicalDrug
Also called Rocurinoum 0.6 mg/kg intravenous
Comparing lidocaine spray and muscle relaxing medication
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine spray on the glottis | Active comparator | Lidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation Receives: Drug: Lidocaine topical |
| Muscle relaxing medication | Active comparator | Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation Receives: Drug: Lidocaine topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of hoarseness 1 hour after extubation
Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia
Measured: 1 hours
Secondary outcomes (11)
Intubation conditions
Cormack \& Lehane four degrees
Measured: Before intubation
Number of intubation attempts
Number
Measured: At intubation
Number of patients needing extra equipment for intubating
bourgie, c-mac, other
Measured: At intubation
Proportion of patients who cough when spraying
yes/no
Measured: At intubation
Proportion of patients with normal anatomy in upper airways
yes/no
Measured: At intubation
Blood pressure changes during intubation
Blood pressure before and 2 minutes after intubation
Measured: at intubation
Heart rate changes during intubation
Heart rate before and 2 minutes after intubation
Measured: at intubation
Proportion of patients who cough on tube at extubation
yes/no
Measured: At extubation
Proportion of patients with blood on tube after extubation
yes/no
Measured: At extubation
Degree of hoarsness 24 and 48 hours after extubation
Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia
Measured: 2-48 hours
Proportion of patients reporting different degrees of sore throat at 2, 24 and 48 hours after extubation
0=no, 1=mild, 2=moderate, constant pain when swallowing, 3=severe pain needing analgesia
Measured: 2-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Mar 2023
- Primary completion15 Oct 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomization through randomization.com. Proprotion of hoarseness grade-2-or-3 = 30 % in spray and 10 % in rocuronium. 59 patients in each arm. "sig p \<= ,05", H0 = 0 + 1,96\*√\[30(100-30)n + 10(100-10)/n\] Gitt "power \>= ,80" , HAlt = (30-10) - 0,84\*√\[30(100-30/n) + 10(100- 10/n)\]
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann-Chatrin Leonardsen, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614609
- Sponsor's protocol ID
- Sykehuset Østfold
- Status last verified
- Aug 2025
- First submitted
- 31 Oct 2022
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fjaerestad T, Oyras P, Solbakk KI, Leonardsen AL. Upper airway discomfort: a randomized controlled double-blind trial comparing rocuronium and lidocaine spray for intubation. Eur J Med Res. 2025 Jun 20;30(1):498. doi: 10.1186/s40001-025-02798-8.
PubMed 40542414
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial in a Norwegian Hospital
- ClinicalTrials.gov ID
- NCT05614609
- Acronym / sponsor ID
- Sykehuset Østfold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 14 Nov 2022 (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.
Few studies have compared different methods for optimalizing intubation conditions in general anesthesia. This randomized controlled trial will compare two different methods for intubation in general anesthesia in gastro- or gynecological procedures.
Detailed description
In general anesthesia, it is neccessary to secure the airways with an endotracheal tube. There is no international consensus on how intubation is most efficiently conducted. A cochrane review compared using muscular relaxing medication versus not using blocks for intubation. Primary outcomes were intubation conditions and discomfort in upper airways. The authors concluded that research is limited, and that further research is needed. No studies have compared local anesthetic spray on the glottis and muscular relaxing medication in intubation, focusing on discomfort in upper airways. The null-hypothesis of this study is that there is no difference in upper airway discomfort when using local anesthetic spray or muscular relaxing medication. The study will have a randomized controlled design, randomizing patients undergoing gastro- or gynecological procedures in general anesthesia to receiving either rocuronium (muscle relaxing medication) intravenous, or lidocain spray on the glottis before intubation. The primary outcome is postoperativ hoarseness one hour after intubation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Block randomization through randomization.com. Proprotion of hoarseness grade-2-or-3 = 30 % in spray and 10 % in rocuronium. 59 patients in each arm. "sig p <= ,05", H0 = 0 + 1,96*√[30(100-30)n + 10(100-10)/n] Gitt "power >= ,80" , HAlt = (30-10) - 0,84*√[30(100-30/n) + 10(100- 10/n)]
| Arm | Type | Receives |
|---|---|---|
| Lidocaine spray on the glottis | Active comparator | Drug: Lidocaine topicalLidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation |
| Muscle relaxing medication | Active comparator | Drug: Lidocaine topicalRocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA (American Association of Anesthesiologists Classification system for physical status) I-III
- Understand and can express themselves in Norwegian
- Able to give informed consent to participate
Key exclusion criteria (5 listed)
- Cave lidocain and/or muscle relaxing medication
- BMI above 40
- Anticipated difficult intubation
- Need for ventricular tube
- Pathology or malformations in upper airways
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 |
|---|---|---|
| Lidocaine topicalAlso: Rocurinoum 0.6 mg/kg intravenousComparing lidocaine spray and muscle relaxing medication | Drug | Lidocaine spray on the glottis, Muscle relaxing medication |
Primary outcome
Degree of hoarseness 1 hour after extubation
Time frame: 1 hours
Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia
11 secondary outcomes
Intubation conditions
Time frame: Before intubation
Number of intubation attempts
Time frame: At intubation
Number of patients needing extra equipment for intubating
Time frame: At intubation
Proportion of patients who cough when spraying
Time frame: At intubation
Proportion of patients with normal anatomy in upper airways
Time frame: At intubation
Blood pressure changes during intubation
Time frame: at intubation
Heart rate changes during intubation
Time frame: at intubation
Proportion of patients who cough on tube at extubation
Time frame: At extubation
Proportion of patients with blood on tube after extubation
Time frame: At extubation
Degree of hoarsness 24 and 48 hours after extubation
Time frame: 2-48 hours
Proportion of patients reporting different degrees of sore throat at 2, 24 and 48 hours after extubation
Time frame: 2-48 hours
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 5 Aug 2025.
- Derived from this study: PubMed 40542414Fjaerestad T, Oyras P, Solbakk KI, Leonardsen AL. Upper airway discomfort: a randomized controlled double-blind trial comparing rocuronium and lidocaine spray for intubation. Eur J Med Res. 2025 Jun 20;30(1):498. doi: 10.1186/s40001-025-02798-8.
- 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 study testing Lidocaine topical in people with Postoperative Complications and Intubation; Difficult or Failed, run by Ostfold University College at 1 site in Norway.
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 5 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 5 Aug 2025. 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 Norway. 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?
Degree of hoarseness 1 hour after extubation (time frame: 1 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05614609, which also lists 1 linked publication.
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 5 Aug 2025.