Comparison of magnesium and lidocaine sulfate spray on hemodynamic changes induced by laryngoscopy
Design
Clinical trial with control group, with parallel, double-blind, randomized, phase 2 on 100 patients. For randomization, the rand function of Excel software was used.
Settings and conduct
This study is a double-blind clinical trial and 100 patients aged 18 to 40 years old (in two groups of 50 people) who have no underlying disease and are candidates for elective orthopedic surgery and general surgery, will be studied in Karaj Madani Hospital. Double-blind study means that the person who records vital signs after laryngoscopy and the person who analyzes the statistical results does not know about the two groups A and B and what spray was used in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients aged 18 to 40 years old who are in ASA (American Society Anesthesiology) Class I,II.
BMI is in the range of 19 to 25.
Have a mallampaty score of one or two
Exclusion criteria:
1. Patient dissatisfaction or withdrawal from participation in the study
2. Having sensitivity to magnesium sulfate and lidocaine
3. Being a smoker
Intervention groups
Intervention group are candidates for elective orthopedic surgery and general surgery who receive magnesium sulfate spray
Comparison group is candidate for elective orthopedic surgery and general surgery who receive lidocaine spray
Main outcome variables
Determination of heart rate and blood pressure and ECG changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230719058846N1
Registration date:2023-10-31, 1402/08/09
Registration timing:prospective
Last update:2023-10-31, 1402/08/09
Update count:0
Registration date
2023-10-31, 1402/08/09
Registrant information
Name
Marziye Khalaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4460 9281
Email address
mingming501.n1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of magnesium sulfate and lidocaine spray on hemodynamic changes due to laryngoscopy and Tracheal intubation - Clinical trial
Public title
Comparison of magnesium sulfate and lidocaine spray on hemodynamic changes due to laryngoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 18 to 40 years old who are in ASA (American Society Anesthesiology) Class I,II.
BMI is in the range of 19 to 25
Have a mallampaty score of one or two
Exclusion criteria:
1. Patient dissatisfaction or withdrawal from participation in the study
2. Having sensitivity to magnesium sulfate and lidocaine
3. Being a smoker
4. Having a cold, cough and sputum
5.Have a mallampaty score of three or four
6. In terms of airway examination in the Lemon Law criteria have problem of intubation and diffusion should have.
7.If the laryngoscopy lasts longer than 15 seconds. If there is a problem during laryngoscopy and the patient has a difficult intubation.
8. Having a history of arterial hypertension, tachycardia, bradycardia and arrhythmia
9. Use of hemodynamic drugs such as indral and ...
Age
From 18 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random Method : Simple
Randomization Unit : Individual
Randomization Tool : Using random cards A and B
50 cards A and 50 cards B that have the same appearance are placed in a container without the letters in the card being visible from outside. The study subjects take a card from the inside of the container and are classified into lidocaine or magnesium sulfate depending on the selected card. The selection of the card is permutation free and the card removed will not be placed in the container again. The study subjects will not know the letters in the cards and which of the drugs they are studying. Also, the subjects in the study will not be related to each other.
Blinding (investigator's opinion)
Double blinded
Blinding description
The sprays are uniformed and covered in appearance, and the performer, who is the executor of the project, and the person recording the results do not know about the substance inside them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
No. 5,West 3rd Alley,12 meters of Boostan St, Danesh St, Central Jannatabad, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1475643684
Approval date
2023-06-09, 1402/03/19
Ethics committee reference number
IR.ABZUMS.REC.1402.086
Health conditions studied
1
Description of health condition studied
Hemodynamic changes including heart rate and blood pressure and ECG changes after laryngoscopy
ICD-10 code
I97.8
ICD-10 code description
Other intraoperative and postprocedural complications and disorders of the circulatory system, not elsewhere classified
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
Minutes 1, 3, 5, 7 and 10 from the start of the intervention.
Method of measurement
Operating Room Pressure Gauge
2
Description
heart rate
Timepoint
Minutes 1, 3, 5, 7 and 10 from the start of the intervention.
Method of measurement
Heart Rate Indicator Device in Operating Room
Secondary outcomes
1
Description
changes in ECG
Timepoint
Minutes 1, 3, 5, 7 and 10 from the start of the intervention.
Method of measurement
Electrocardiogram Monitor
Intervention groups
1
Description
Intervention group: In one of the studied patients, 5 puffs of lidocaine 10% containing 10 mg of lidocaine is sprayed in the throat. In the next step for both groups of atracurium relaxant 0.75 mg/kg and after 3 minutes the patient will be laryngoscopy and intubation (intubation is done by expert and maximum within 15 seconds and for men tube eight and for women pipe seven with Macintosh laryngoscope blade 4 will be used after laryngoscopy to measure changes in heart rate and blood pressure and ECG changes in minutes 1, 3, 5, 7 and 10
Category
Treatment - Drugs
2
Description
Intervention group: In one group of patients, 5 puffs of magnesium sulfate spray 20% in the enclave. In the next step for both groups of atrophorium relaxant 0.75 mg/kg and after 3 minutes the patient will be laryngoscopy and intubation (intubation is done by expert and maximum within 15 seconds and for men tube eight and for women tube seven with blade laryngoscope macintosh 4 After laryngoscopy, we measure and record changes in heart rate and blood pressure and ECG changes in minutes 1, 3, 5, 7 and 10.
Deputy of Research and Technology - Saffarian Alley - 45 meters Golshahr - Karaj
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3664 3774
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr.Banafsheh Mashak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kamali Medical Center, Kamali St., Shohada Sq., Shahid Beheshti St., Karaj Province, Iran
City
karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
mashakbanafsheh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr.Banafsheh Mashak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kamali Medical Center, Kamali St., Shohada Sq., Shahid Beheshti St., Karaj Province, Iran
City
karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
mashakbanafsheh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr.Banafsheh Mashak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kamali Medical Center, Kamali St., Shohada Sq., Shahid Beheshti St., Karaj Province, Iran
City
karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
mashakbanafsheh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The whole data is potentially shareable after making people unidentifiable.
When the data will become available and for how long
Beginning of access period 6 months after publication of results
To whom data/document is available
Researchers working in academic and scientific institutions and people working in industry
Under which criteria data/document could be used
For other scientific and research studies
Dastva Studies and Measures
Use in medical centers
From where data/document is obtainable
Executor of Dr. Khalaji with Email Address
mar_k98@yahoo.com
What processes are involved for a request to access data/document
Send an email to the project's executor
Introducing the requesting person and organization
Explanation of the purpose of the individual or organization of access to information