Protocol summary

Study aim
Comparison of the effect of intravenous Esmolol administration with intravenous lidocaine on hemodynamic variables during laryngoscopy and endotracheal intubation and postoperative nausea and vomiting in female patients undergoing abdominal surgery
Design
This study is a one-blind randomized clinical trial, without control group, with 2 intervention parallel groups and phase 2-3, in which 64 patients are randomly divided into 2 groups of 32 using a random number table.
Settings and conduct
This trial is performed by a researcher in the Kowsar operating room of Shahid Sadoughi Hospital in Yazd, in 2 groups of 32 people. Patients do not know the type of drug, In the first group, Labetalol and the second group, lidocaine is injected intravenously. The mentioned hemodynamic variables are measured in the times; immediately before the injection of drug and laryngoscopy, immediately after endotracheal intubation, immediately after skin incision and the result is recorded in the questionnaire. side effects; Bradycardia, hypotension, nausea and vomiting are evaluated and recorded in a questionnaire. Finally, the results are analyzed by SPSS software and relevant statistical tests
Participants/Inclusion and exclusion criteria
Inclusion criteria: All female patients who are candidates for gynecological abdominal surgery Exclusion criteria: arterial hypertension, ischemic heart disease, severe heart disease, ASA Class I, II, pulmonary, renal, hepatic, addiction.
Intervention groups
A total of 64 patients are randomly divided into two groups of 32 using a random number table. In the first group, intravenous osmolol (0.5 mg / kg) is injected immediately before induction of general anesthesia and in the second group, intravenous lidocaine (1.5 mg / kg) is injected.
Main outcome variables
Hemodynamic variables including systolic, diastolic, mean arterial blood pressure and heart rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100102002963N32
Registration date: 2021-06-12, 1400/03/22
Registration timing: registered_while_recruiting

Last update: 2021-06-12, 1400/03/22
Update count: 0
Registration date
2021-06-12, 1400/03/22
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-06, 1400/03/16
Expected recruitment end date
2021-07-07, 1400/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous Esmolol and intravenous Lidocaine on hemodynamic variables during laryngoscopy and tracheal intubation and postoperative nausea and vomiting in patients undergoing abdominal surgery
Public title
Effect of intravenous Esmolol and intravenous Lidocaine on hemodynamic variables during laryngoscopy and tracheal intubation and postoperative nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All female patients are candidates for gynecological abdominal surgery
Exclusion criteria:
Arterial hypertension Ischemic heart disease Heart failure Pulmonary disease Addiction Renal disease Liver disease
Age
From 25 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly allocate 64 eligible applicants, we randomly divide them into two groups of 32 people. For this purpose, we use Random allocation software version 1.0 under Windows to creat sequence, and by using this software we make A list which is specified from 1 to 64 with group A or B treatment By using this list, we give the first oerson who is eligible to enter the study, number 1 and the last person the number 64, then based on the random allocation list and by the software, it is determinded which group A or B each person is in.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only patients are unaware of how to group and the amount and type of medication used It is necessary to mention in this research the drugs used and Their levels in both experimental groups are completely routine and tested The only side effects of the drug from the time of injection of the drug until the end of its effect and Nausea and vomiting are assessed in two groups and recorded if they occur.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ali Ibn Abi Talib Medical School (AS), Islamic Azad University, Yazd Branch
Street address
Safaieh, Boulevard of the Shohadaie Gomnam
City
YAZD
Province
Yazd
Postal code
8915813135
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.IAU.YAZD.REC.1399.029

Health conditions studied

1

Description of health condition studied
Comparison of the effect of intravenous osmolol and intravenous lidocaine on hemodynamic variables during laryngoscopy and tracheal intubation and postoperative nausea and vomiting in patients undergoing abdominal surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changes in systolic blood pressure
Timepoint
Immediately before drug injection immediately before laryngoscopy immediately after endotracheal intubation immediately after skin incision
Method of measurement
Operating room monitoring with Blood pressure cuff connected to the monitor and recording information in a questionnaire

2

Description
Determining and comparing the incidence of bradycardia ( heart rate <50 )
Timepoint
Immediately after the operation in recovery room
Method of measurement
Monitoring in the recovery room with a blood pressure monitor connected to the monitor and recording information in a questionnaire

3

Description
Determining and comparing the incidence of vomiting and nausea
Timepoint
Immediately after the operation in recovery room
Method of measurement
Question from the patient and registration in the questionnaire

4

Description
Changes in diastolic blood pressure
Timepoint
Immediately before drug injection Immediately before laryngoscopy Immediately after endothracheal intubation Immediately after skin incision
Method of measurement
Operating room monitoring with Blood pressure cuff connected to the monitor and recording information in a questionnaire

5

Description
Changes in mean arterial blood pressure
Timepoint
Immediately before drug injection Immediately before laryngoscopy Immediately after intubation Immediately after skin incision
Method of measurement
Operating room monitoring with Blood pressure cuff connected to the monitor and recording infirmation in a questionnaire

6

Description
Changes in heart rates
Timepoint
Immediately before drug injection Immediately before laryngoscoy Immediately after endothracheal intubation Immediately after skin incision
Method of measurement
Operating room monitoring with Blood pressure cuff connected to the monitor and recording information in a questionnaire

7

Description
Determining and comparing the incidence of hypotension side effects ( systolic blood pressure <9 ) or drop of more than 20% of the base rate
Timepoint
Immediately after the operation in recovery room
Method of measurement
Monitoring in the recovery room with a blood pressure monitor connected to the monitor and recording information in a questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In this group, 0.5 mg/kg of Esmolol, from Myungmoon pharmaceutical Co., Ltd is injected intravenously and once immediately before induction of general anesthesia to eligible patients.
Category
Treatment - Drugs

2

Description
Intervention group 2: In this group, lidocaine 1.5 mg per kg body weight of the patient, from Caspian tamin company is injected intravenously and once immediately before induction of general anesthesia to eligible patients.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Dr. Shokoofeh Behdad
Street address
Ibn Sina Street, Shahid Ghandi Boulevard, Safaieh
City
YAZD
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
sadoghi-hospital@ssu.ac.ir
Web page address
https://web.ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Azad Islamic University Of Yazd
Full name of responsible person
Dr Seyed Mohammadreza Mortazavi Zade
Street address
Boulevard of the Shohadaie Gomnam, Safaieh
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3187 2200
Fax
+98 35 3821 5034
Email
info@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad Islamic University Of Yazd
Proportion provided by this source
100
Public or private sector
Private
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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Shekoufeh Behdad
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Sadoughi Hospital, Ebnesina Blv, Safayieh, Yazd
City
YAZD
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4101
Email
behdad90@gmail.com
Web page address
https://web.ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Shekofeh Behdad
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Sadoughi Hospital, Ebnesina Blv, Safayieh, Yazd
City
YAZD
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4101
Email
behdad90@gmail.com
Web page address
https://web.ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Shekofeh Behdad
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Sadoughi Hospital, Ebnesina Blv, Safayieh, Yazd
City
YAZD
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4101
Email
behdad90@gmail.com
Web page address
https://web.ssu.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
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