Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial
- Conditions
- Intubation ComplicationIntubation; Difficult or FailedPostoperative Complications
- Interventions
- Registration Number
- NCT05614609
- Lead Sponsor
- Ostfold University College
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- Cave lidocain and/or muscle relaxing medication
- BMI above 40
- Anticipated difficult intubation
- Need for ventricular tube
- Pathology or malformations in upper airways
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine spray on the glottis Lidocaine topical Lidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation Muscle relaxing medication Lidocaine topical Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation
- Primary Outcome Measures
Name Time Method Degree of hoarseness 1 hour after extubation 1 hours Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia
- Secondary Outcome Measures
Name Time Method Proportion of patients who cough on tube at extubation At extubation yes/no
Number of patients needing extra equipment for intubating At intubation bourgie, c-mac, other
Proportion of patients who cough when spraying At intubation yes/no
Intubation conditions Before intubation Cormack \& Lehane four degrees
Number of intubation attempts At intubation Number
Proportion of patients with normal anatomy in upper airways At intubation yes/no
Heart rate changes during intubation at intubation Heart rate before and 2 minutes after intubation
Proportion of patients with blood on tube after extubation At extubation yes/no
Blood pressure changes during intubation at intubation Blood pressure before and 2 minutes after intubation
Degree of hoarsness 24 and 48 hours after extubation 2-48 hours Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia
Proportion of patients reporting different degrees of sore throat at 2, 24 and 48 hours after extubation 2-48 hours 0=no, 1=mild, 2=moderate, constant pain when swallowing, 3=severe pain needing analgesia
Trial Locations
- Locations (1)
Ann-Chatrin Linqvist Leonardsen
🇳🇴Kråkerøy, Østfold, Norway