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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614609
• Other study ID #: Sykehuset Østfold
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: Ostfold University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 two hours after intubation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication
• Intubation; Difficult or Failed
• Postoperative Complications

Intervention

Drug:
• Lidocaine topical
Comparing lidocaine spray and muscle relaxing medication

Locations

Country	Name	City	State
Norway	Ann-Chatrin Linqvist Leonardsen	Kråkerøy	Østfold

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold University College

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of hoarseness 2 hours after extubation	Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia	2 hours
Secondary	Intubation conditions	Cormack & Lehane four degrees	Before intubation
Secondary	Number of intubation attempts	Number	At intubation
Secondary	Number of patients needing extra equipment for intubating	bourgie, c-mac, other	At intubation
Secondary	Proportion of patients who cough when spraying	yes/no	At intubation
Secondary	Proportion of patients with normal anatomy in upper airways	yes/no	At intubation
Secondary	Blood pressure changes during intubation	Blood pressure before and 2 minutes after intubation	at intubation
Secondary	Heart rate changes during intubation	Heart rate before and 2 minutes after intubation	at intubation
Secondary	Proportion of patients who cough on tube at extubation	yes/no	At extubation
Secondary	Proportion of patients with blood on tube after extubation	yes/no	At extubation
Secondary	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
Secondary	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