Comparison of lidocaine gel and lubricant gel on hemodynamic symptoms and withdrawal reactions with two methods of laryngeal mask and endotracheal tube in patients undergoing cataract surgery
Comparison of lidocaine gel and lubricant gel methods on hemodynamic symptoms and withdrawal reactions under anesthesia with laryngeal mask and endotracheal tube in patients undergoing cataract surgery
Design
This study will be a randomized clinical trial with parallel groups on 66 patients referred to Peymaniyeh Motahhari Hospital in Jahrom who undergo cataract surgery. Patients participating in the study will be divided into two groups by tossing coins.
Settings and conduct
Patients referred to Motahhari Hospital in Jahrom who will undergo cataract surgery will be included in the study. Patients participating in the study will be divided into two groups by endotracheal intubation and laryngeal mask by throwing coins.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Motahhari Hospital in Jahrom who underwent cataract surgery and expressed their consent to participate in the study. Non-entry conditions: includes patients who do not have hemodynamic stability and suffer from acute and chronic pain.
Intervention groups
Intervention group 1: In order to establish the airway in this group, endotracheal intubation was used. The members of this group were intubated with three methods: lidocaine gel, lubricant gel and normal sign.
Intervention group 2: To establish the airway in this group, laryngeal mask was used. The members of this group tried to maintain the airway with three methods: lidocaine gel, lubricant gel and normal sign.
Main outcome variables
Hemodynamic symptoms, sore throat and cough, agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N6
Registration date:2021-08-06, 1400/05/15
Registration timing:prospective
Last update:2021-08-06, 1400/05/15
Update count:0
Registration date
2021-08-06, 1400/05/15
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of lidocaine gel and lubricant gel on hemodynamic symptoms and withdrawal reactions with two methods of laryngeal mask and endotracheal tube in patients undergoing cataract surgery
Public title
Comparison of lidocaine gel and lubricant gel on hemodynamic symptoms and withdrawal reactions with two methods of laryngeal mask and endotracheal tube in patients undergoing cataract surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodynamic stability
ASA (Class 1 and 2 were considered as inclusion criteria)
Exclusion criteria:
History of cardiovascular disease
Shortness of breath
Glaucoma
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. With the help of the online site (www.sealedenvelope.com/simple-randomiser/v1/lists) randomization, 4 blocks of 14 are created. In each randomly assigned block, 14 patients are assigned to the endotracheal intubation group and 14 patients to the laryngeal mask group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
jahrom
Province
Fars
Postal code
7167758256
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.JUMS.REC.1399.147
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
E08.36
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic cataract
Primary outcomes
1
Description
Hemodynamic symptoms
Timepoint
It will be measured before, immediately, 5, 15 and 30 minutes after anesthesia as well as during recovery.
Method of measurement
monitoring
2
Description
Agitation
Timepoint
Immediately after transfer to recovery, 1, 6, 12 and 24 hours after surgery in the ophthalmology department
Method of measurement
The measure of restlessness
3
Description
Sore throat
Timepoint
Immediately after transfer to recovery, 1, 6, 12 and 24 hours after surgery in the ophthalmology department
Method of measurement
VAS criteria
4
Description
Cough
Timepoint
Immediately after transfer to recovery, 1, 6, 12 and 24 hours after surgery in the ophthalmology department
Method of measurement
Based on having or not having a cough
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
Immediately after transfer to recovery, 1, 6, 12 and 24 hours after surgery in the ophthalmology department
Method of measurement
Vomiting nausea questionnaire
2
Description
chills
Timepoint
Immediately after transfer to recovery, 1, 6, 12 and 24 hours after surgery in the ophthalmology department
Method of measurement
Shivering Questionnaire
Intervention groups
1
Description
Intervention group 1: In order to establish the airway in this group, endotracheal intubation was used. The individuals of this group were intubated with three methods: lidocaine gel, lubricant gel and normal sign.From each of the lidocaine, lubricant or normal saline gels, 3 cc is drawn and poured separately on the cuff part of the tube.
Category
Treatment - Devices
2
Description
Intervention group 2: To establish the airway in this group, laryngeal mask was used. The members of this group tried to maintain the airway with three methods: lidocaine gel, lubricant gel and normal sign.From each of the lidocaine, lubricant or normal saline gels, 3 cc is drawn and poured separately on the cuff part of the tube.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital of Jahrom city
Full name of responsible person
Navid Kalani
Street address
Jahrom, Shahid Motahari Boulevard
City
jahrom
Province
Fars
Postal code
71677251542
Phone
+98 71 3525 5652
Email
Navidkalani@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavose Solh Joo
Street address
Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
Navidkalani@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahrom, Shahid Motahari Boulevard
City
jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
k.navid@jums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
k.navid@jums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
k.navid@jums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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