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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Intubation Complication; Intubation; Difficult or Failed
• Intervention / Treatment: Drug: Lidocaine topical

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 two hours after intubation.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Østfold
    • Kråkerøy, Østfold, Norway, 1679
      • Recruiting
      • Ann-Chatrin Linqvist Leonardsen
      • Contact: Ann -Chatrin L Leonardsen, PhD; Phone Number: +4741668797; Email: ann.c.leonardsen@hiof.no
      • Contact: Waleed Ghanima, PhD, Professor; Email: waleed.ghanima@so-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine spray on the glottis; Lidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation	Drug: Lidocaine topical; Comparing lidocaine spray and muscle relaxing medication; Other Names: Rocurinoum 0.6 mg/kg intravenous
Active Comparator: Muscle relaxing medication; Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation	Drug: Lidocaine topical; Comparing lidocaine spray and muscle relaxing medication; Other Names: Rocurinoum 0.6 mg/kg intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation conditions	Cormack & Lehane four degrees	Before intubation
Number of intubation attempts	Number	At intubation
Number of patients needing extra equipment for intubating	bourgie, c-mac, other	At intubation
Proportion of patients who cough when spraying	yes/no	At intubation
Proportion of patients with normal anatomy in upper airways	yes/no	At intubation
Blood pressure changes during intubation	Blood pressure before and 2 minutes after intubation	at intubation
Heart rate changes during intubation	Heart rate before and 2 minutes after intubation	at intubation
Proportion of patients who cough on tube at extubation	yes/no	At extubation
Proportion of patients with blood on tube after extubation	yes/no	At extubation
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
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

Collaborators and Investigators

• Sponsor: Ostfold University College

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 5, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Sykehuset Østfold

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No