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

Primary Purpose

Postoperative Complications, Intubation; Difficult or Failed, Intubation Complication

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lidocaine topical
Sponsored by
Ostfold University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postoperative Complications

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ann-Chatrin Linqvist LeonardsenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lidocaine spray on the glottis

Muscle relaxing medication

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 31, 2022
Last Updated
March 21, 2023
Sponsor
Ostfold University College
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1. Study Identification

Unique Protocol Identification Number
NCT05614609
Brief Title
Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial
Official Title
Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial in a Norwegian Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ostfold University College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Intubation; Difficult or Failed, Intubation Complication

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)]
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine spray on the glottis
Arm Type
Active Comparator
Arm Description
Lidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation
Arm Title
Muscle relaxing medication
Arm Type
Active Comparator
Arm Description
Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation
Intervention Type
Drug
Intervention Name(s)
Lidocaine topical
Other Intervention Name(s)
Rocurinoum 0.6 mg/kg intravenous
Intervention Description
Comparing lidocaine spray and muscle relaxing medication
Primary Outcome Measure Information:
Title
Degree of hoarseness 2 hours after extubation
Description
Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Intubation conditions
Description
Cormack & Lehane four degrees
Time Frame
Before intubation
Title
Number of intubation attempts
Description
Number
Time Frame
At intubation
Title
Number of patients needing extra equipment for intubating
Description
bourgie, c-mac, other
Time Frame
At intubation
Title
Proportion of patients who cough when spraying
Description
yes/no
Time Frame
At intubation
Title
Proportion of patients with normal anatomy in upper airways
Description
yes/no
Time Frame
At intubation
Title
Blood pressure changes during intubation
Description
Blood pressure before and 2 minutes after intubation
Time Frame
at intubation
Title
Heart rate changes during intubation
Description
Heart rate before and 2 minutes after intubation
Time Frame
at intubation
Title
Proportion of patients who cough on tube at extubation
Description
yes/no
Time Frame
At extubation
Title
Proportion of patients with blood on tube after extubation
Description
yes/no
Time Frame
At extubation
Title
Degree of hoarsness 24 and 48 hours after extubation
Description
Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia
Time Frame
2-48 hours
Title
Proportion of patients reporting different degrees of sore throat at 2, 24 and 48 hours after extubation
Description
0=no, 1=mild, 2=moderate, constant pain when swallowing, 3=severe pain needing analgesia
Time Frame
2-48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ann-Chatrin Linqvist Leonardsen
City
Kråkerøy
State/Province
Østfold
ZIP/Postal Code
1679
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann -Chatrin L Leonardsen, PhD
Phone
+4741668797
Email
ann.c.leonardsen@hiof.no
First Name & Middle Initial & Last Name & Degree
Waleed Ghanima, PhD, Professor
Email
waleed.ghanima@so-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No

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

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