Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial in a Norwegian Hospital

Sykehuset Østfold

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.

2023-03-01

2024-10-15

2025-01-31

Recruiting

120

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Block randomization through randomization.com. Proprotion of hoarseness grade-2-or-3 = 30 % in spray and 10 % in rocuronium.\n\n59 patients in each arm.\n\n"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)\\]', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-04-02