Postoperative Complications, Intubation; Difficult or Failed, Intubation Complication
Conditions
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.
Interventions
Comparing lidocaine spray and muscle relaxing medication
Sponsors
Ostfold University College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
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\*√\[30(100-30/n) + 10(100- 10/n)\]
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Proportion of patients with normal anatomy in upper airways | At intubation | yes/no |
| Blood pressure changes during intubation | at intubation | Blood pressure before and 2 minutes after intubation |
| 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 |
| Intubation conditions | Before intubation | Cormack & Lehane four degrees |
| Number of intubation attempts | At intubation | Number |
| 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 |
| Proportion of patients who cough on tube at extubation | At extubation | yes/no |
Countries
Norway
Outcome results
None listed