Comparative evaluation between two methods including induced hypotension with infusion of labetalol and lidocaine during tympanoplasty surgery
Design
Interventional study, double blind, with parallel group design. The sample size will be 64. Randomization will be done based on the table extracted from www.randomization.com site and using blocks of size 4.
Settings and conduct
Sixty four (64) patients candidate for Tympanoplasty will be recruited from Dastghaib and Khalili hospitals in Shiraz and will be divided into two groups of 32. In one group lidocaine and in the other group labetalol will be infused immediately after intubation until end of surgery. Patients are coded by the researcher based on the randomized list. Then the drug is prepared based on the list and will be provided to the anesthesia expert to give to each patient. In this way, the researcher, the patient and anesthesia expert and evaluators will be kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing tympanoplasty; being at the age range of 18-60 years old and class I,II ASA. Non Inclusion criteria: Drug sensitivity to Labetalol and Lidocain; history of hypertension and heart disorders; liver disorder; renal disorder; hormonal disorder; having chronic pain
Intervention groups
After induction & intubation, before injection of local anesthesia agent and surgical incision, In the first group, labetalol 0.5 % (Exir Co.), 20mg bolus will be injected during 2 minutes in supine position, then 0.5-2mg/min by syringe pump to max 300mg is infused. In the second group, a bolus dose of 1.5mg/kg lidocaine 1% (Exir Co.) will be injected in supine position during 2 minutes, then, 1.5mg/kg/h will be infused by syringe pump. It will be continued until reaching the proper pressure and until the end of the surgery in both groups.
Main outcome variables
Blood pressure level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180922041084N3
Registration date:2019-03-01, 1397/12/10
Registration timing:prospective
Last update:2019-03-01, 1397/12/10
Update count:0
Registration date
2019-03-01, 1397/12/10
Registrant information
Name
Maryam Tabibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1460
Email address
dpt2370349433@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation between two methods of induced hypotension including infusion of labetalol and lidocaine during tympanoplasty surgery
Public title
Comparison of infusion of labetalol and lidocaine during tympanoplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing tympanoplasty
Being at the age range of 18-60 years old
Being at class I and II ASA
Exclusion criteria:
Drug sensitivity to Labetalol and Lidocain
History of hypertension and heart disorders
Liver disorder
Renal disorder
Hormonal disorder
Having chronic pain
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patient randomization will be done based on the table extracted from www.randomization.com site in the form of blocks of size 4.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients are coded by the researcher based on the randomized list. Then the drug is prepared based on the list and will be provided to the anesthesia expert to assign to each patient. In this way, the researcher, the patient and anesthesia expert and evaluators will be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2018-12-24, 1397/10/03
Ethics committee reference number
IR.SUMS.MED.REC.1397.391
Health conditions studied
1
Description of health condition studied
Induced Hypotension
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood pressure level
Timepoint
Before and after induction of anesthesia,during operation and after operation
Method of measurement
By automatic blood pressure monitoring
Secondary outcomes
1
Description
Heart rate
Timepoint
Before and after induction and intraoperation and postoperation
Method of measurement
By pulse oximetry
2
Description
Arterial oxygen saturation
Timepoint
Before and after induction and intraoperation and postoperation
Method of measurement
By pulse oximetry
3
Description
End tidal co2
Timepoint
intraoperation
Method of measurement
By capnography
4
Description
Pain level
Timepoint
postoperation
Method of measurement
By visual analogue scale
5
Description
Surgen satisfaction level
Timepoint
Intraoperation
Method of measurement
By likert scale
6
Description
Dose of received fentanyl
Timepoint
intraoperation
Method of measurement
patient's document
Intervention groups
1
Description
Intervention group 1: in first group immediately after induction and intubation and before injection and surgical incision, labetalol 0.5 % (manufactured by Exire company) 20mg bolous during 2 minutes in supine position will be injected. Then infusion will be continued at the dose of 0.5_2mg/min to max 300mg or reaching the proper pressure by syringe pump until the end of surgery.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the second group, immediately after the induction and intubation and before the injection of anesthesia and incision by the surgeon, a bolous dose of lidocaine 1% (manufacture by Exire company) will be injected bolously at the dose of 1_2 mg/kg body weight during 2 minutes in supine position and after that it will be continued at the dose of 1.5mg/kg body weight until the end of the operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalil Hospital
Full name of responsible person
Mehdi Rahmati
Street address
Khalili Street
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1407
Email
mehdirahmati55@yahoo.com
2
Recruitment center
Name of recruitment center
Dastghaib hospital
Full name of responsible person
Mehdi Rahmati
Street address
Eighth Avenue, Hafez Street
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1407
Email
mehdirahmati55@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Younes Ghasemi
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mehdi Haidari
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
mehdirahmati55@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinabosadat Fatahi saravi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
parniafattahi@rocketmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Tabibzadeh
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
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