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

Sponsor

Ostfold University College (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05614609

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications Intubation; Difficult or Failed Intubation Complication	Drug: Lidocaine topical	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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)]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)]

Masking:

Double (Participant, Care Provider)

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.

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Nov 15, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Degree of hoarseness 2 hours after extubation [2 hours]
Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia

Secondary Outcome Measures

Intubation conditions [Before intubation]
Cormack & Lehane four degrees
Number of intubation attempts [At intubation]
Number
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 who cough on tube at extubation [At extubation]
yes/no
Proportion of patients with blood on tube after extubation [At extubation]
yes/no
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ostfold University College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ann-Chatrin Leonardsen, Professor, Ostfold Hospital Trust

ClinicalTrials.gov Identifier:

NCT05614609

Other Study ID Numbers:

Sykehuset Østfold

First Posted:

Nov 14, 2022

Last Update Posted:

Jan 20, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Postoperative Complications

Lidocaine

Study Results

No Results Posted as of Jan 20, 2023