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

NCT05614609 | Completed

• 1 other identifier: Sykehuset Østfold
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Intubation; Difficult or Failed; Intubation Complication

Outcome Measures

Primary Outcomes (1)

• Degree of hoarseness 1 hour after extubation

  Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia

  1 hours

Secondary Outcomes (11)

• Intubation conditions

  Before intubation

• Number of intubation attempts

  At intubation

• Number of patients needing extra equipment for intubating

  At intubation

• Proportion of patients who cough when spraying

  At intubation

• Proportion of patients with normal anatomy in upper airways

  At intubation

Study Arms (2)

Lidocaine spray on the glottis

ACTIVE COMPARATOR

Lidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation

Drug: Lidocaine topical

Muscle relaxing medication

ACTIVE COMPARATOR

Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation

Drug: Lidocaine topical

Interventions

Lidocaine topical DRUG

Comparing lidocaine spray and muscle relaxing medication

Also known as: Rocurinoum 0.6 mg/kg intravenous

Lidocaine spray on the glottis; Muscle relaxing medication

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ostfold University College: lead

Study Sites (1)

Ann-Chatrin Linqvist Leonardsen

Kråkerøy, Østfold fylke, 1679, Norway

Location

Related Publications (1)

• Fjaerestad T, Oyras P, Solbakk KI, Leonardsen AL. Upper airway discomfort: a randomized controlled double-blind trial comparing rocuronium and lidocaine spray for intubation. Eur J Med Res. 2025 Jun 20;30(1):498. doi: 10.1186/s40001-025-02798-8.

  PMID: 40542414 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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\*√\[30(100-30/n) + 10(100- 10/n)\]

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 14, 2022
• Study Start: March 1, 2023
• Primary Completion: October 15, 2024
• Study Completion: January 31, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)