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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Muscle relaxing medication | Active Comparator | Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine topical | Drug | Comparing lidocaine spray and muscle relaxing medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation conditions | Cormack & Lehane four degrees | Before intubation |
| Number of intubation attempts | Number | At intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann-Chatrin Linqvist Leonardsen | Kråkerøy | Østfold fylke | 1679 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40542414 | Derived | 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. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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)]
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A study nurse will prepare sealed envelopes with the study-arm specified inside. Patients fullfilling the inclusion criteria will be invited to participate. Patients will be blinded for study arm. Intubation will be performed by trained intubators. However, due to the medications possible risk for rest-curarisation, the anesthesia personnel will possibly be able to detect intervention. However, care personnel collecting data will not know which study arm the patient belongs to.
| Number of patients needing extra equipment for intubating | bourgie, c-mac, other | At intubation |
| Proportion of patients who cough when spraying | yes/no | At intubation |
| Proportion of patients with normal anatomy in upper airways | yes/no | At intubation |
| Blood pressure changes during intubation | Blood pressure before and 2 minutes after intubation | at intubation |
| Heart rate changes during intubation | Heart rate before and 2 minutes after intubation | at intubation |
| Proportion of patients who cough on tube at extubation | yes/no | At extubation |
| Proportion of patients with blood on tube after extubation | yes/no | 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 | 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 | 2-48 hours |
| Aniline Compounds |
| D000588 | Amines |