Comparison of the cold normal saline, lidocaine and metoclopramide and the combination of lidocaine and cold normal saline on pain caused by propofol injection
Comparison of the use of cold serum, lidocaine and metoclopramide and the combination of lidocaine and cold serum on pain caused by propofol injection
Design
In this double-blind clinical trial, 120 patients aged 18-60 years (number of samples based on previous studies) with ASA class 1, 2 who are candidates for elective surgery under general anesthesia are randomly selected. Patients who experience pain at the injection site before the injection of the drug or propofol, or if the patient is anxious or uncooperative or allergic to any of the drugs under study, and patients with a history of seizure disorders, cardiovascular disease And have psychiatric problems will also be excluded from the study.
Settings and conduct
It was performed in Sabzevar city relief hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Need for general anesthesia with propofol injection with consent to participate in evaluation between 18 and 60 years old with ASA class 1 and 2
Exclusion criteria:
Reluctance to study
Patients under 20 years and over 60 years
Patients with ASA grade equal to or greater than 3
Patients with advanced heart and lung problems
Sensitivity to any of the drugs used in the study
Intervention groups
Patients are randomly divided into 4 groups of 30 people. Without any anesthetic prodrug, the first group as the control group will be injected with 10 ml of normal saline at room temperature, the second group with 10 ml of 0.5% lidocaine, and the third group with 10 ml of 4 ° C normal saline
Main outcome variables
Age; Gender; Medication; Pain rate; Duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170404033202N10
Registration date:2022-03-23, 1401/01/03
Registration timing:retrospective
Last update:2022-03-23, 1401/01/03
Update count:0
Registration date
2022-03-23, 1401/01/03
Registrant information
Name
Atefeh Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 9180
Email address
a.asadi.mm.1384@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the cold normal saline, lidocaine and metoclopramide and the combination of lidocaine and cold normal saline on pain caused by propofol injection
Public title
Comparison of the cold normal saline, lidocaine and metoclopramide and the combination of lidocaine and cold normal saline on pain caused by propofol injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Need for general anesthesia with propofol injection
with consent to participate in evaluation
between 18 and 60 years old
ASA class 1 and 2
Exclusion criteria:
Reluctance to studyPatients
Patients under 20 years and over 60 years
Patients with ASA grade equal to or greater than 3
Patients with advanced heart and lung problems
Sensitivity to any of the drugs used in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected at random using the most available people for the study. Each person was given a code A or B at random (sheet or envelope) and treatment was performed based on it (group A was intervention and group B was control).
Blinding (investigator's opinion)
Double blinded
Blinding description
In all groups, the amount of pain at 0, 15, and 30 minutes after propofol injection is assessed by another observer who is unaware of the type of drug being injected, based on the VAS, from zero to 10 (zero painless, 10 severe pain).
Outcome assessment is also done by someone who does not know about the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar Medical Sciences
Street address
Sabzevar Medical Sciences Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Approval date
2021-10-12, 1400/07/20
Ethics committee reference number
IR.MEDSAB.REC.1400.172
Health conditions studied
1
Description of health condition studied
Reduction of pain caused by propofol in anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction of pain caused by propofol injection after drug injection
Timepoint
Pain rate at 0, 15 and 30 minutes after propofol injection
Method of measurement
Based on VAS from zero to 10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The case group consisting of four groups including the first group will inject 10 ml of 0.5% lidocaine at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics.
Category
Treatment - Drugs
2
Description
Intervention group 2: The second group will inject 10 ml of normal serum cold saline 4 degrees at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics.
Category
Treatment - Drugs
3
Description
Intervention group 3: The third group will inject 10 ml of 0.5% lidocaine with 10 cc of normal saline 4 ° at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics.
Category
Treatment - Drugs
4
Description
Intervention group4: The fourth group will be injected with 10 mg metoclerine pyramid at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics.
Category
Treatment - Drugs
5
Description
Control group: The control group will be injected with 10 ml of normal saline at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Relief Hospital
Full name of responsible person
Mohammad Nematshahi
Street address
Razi Street Relief Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Phone
+98 51 4466 1128
Email
9151737407mn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Saghee
Street address
Sabzevar Medical Sciences Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Phone
+98 51 4444 1101
Email
9151737407mn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Nematshahi
Position
Ass0ciate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Asadabadi St., Central Organization of Sabzevar University of Medical Sciences
City
Sabzwvar
Province
Razavi Khorasan
Postal code
913885697
Phone
098 51 44229081
Email
9151737407mn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Nematshahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Asadabadi St., Central Organization of Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Phone
+98 51 4422 9081
Email
9151737407mn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Nematshahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Asadabadi St., Central Organization of Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Phone
+98 51 4422 9081
Email
9151737407mn@gmail.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
Not applicable
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