Clinical trial NCT05614609: Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial
Official title: Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial in a Norwegian Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Complications
Intubation; Difficult or Failed
Intubation Complication
Lead sponsor: Ostfold University College
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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\*√\[30(100-30/n) + 10(100- 10/n)\]
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Cave lidocain and/or muscle relaxing medication
* BMI above 40
* Anticipated difficult intubation
* Need for ventricular tube
* Pathology or malformations in upper airways

Primary outcomes:
measure: Degree of hoarseness 1 hour after extubation
timeFrame: 1 hours
Secondary outcomes:
measure: Intubation conditions
timeFrame: Before intubation
measure: Number of intubation attempts
timeFrame: At intubation
measure: Number of patients needing extra equipment for intubating
timeFrame: At intubation
measure: Proportion of patients who cough when spraying
timeFrame: At intubation
measure: Proportion of patients with normal anatomy in upper airways
timeFrame: At intubation
measure: Blood pressure changes during intubation
timeFrame: at intubation
measure: Heart rate changes during intubation
timeFrame: at intubation
measure: Proportion of patients who cough on tube at extubation
timeFrame: At extubation
measure: Proportion of patients with blood on tube after extubation
timeFrame: At extubation
measure: Degree of hoarsness 24 and 48 hours after extubation
timeFrame: 2-48 hours
measure: Proportion of patients reporting different degrees of sore throat at 2, 24 and 48 hours after extubation
timeFrame: 2-48 hours
Other outcomes:
Locations:
city: Kråkerøy
country: Norway
facility: Ann-Chatrin Linqvist Leonardsen
state: Østfold
Study officials:
References: