Monitoring and comparison of fluctuations in blood oxygen saturation in two methods of induction of anesthesia by priming and succinylcholine in patients undergoing appendectomy
comparison of fluctuations in blood oxygen saturation in two methods of induction of anesthesia by priming and succinylcholine in patients undergoing appendectomy
Design
This control trial had a control group, with parallel, double-blind, randomized groups. AND 50 patients
Settings and conduct
This study will be performed on 50 patientsr appendectomy at Sabzevar Hospital. as a two-way blind, in which the patient and the researcher are blinded to the group of patients. Background information will include age, sex. In this study, 0.02 mg / kg midazolam and 2 μg / kg fentanyl were given as pretreatment in both groups, and after three minutes in group A, 5 mg / kg sodium thiopental. And then scolin will be given at a dose of 1.5 mg / kg and after 30 seconds the patient is intubated and then atracurium 0.5 mg / kg is prescribed. And after 4 minutes sodium thiopental at a rate of 5 ml / kg and also the rest of the atracorium is administered and after 60 to 90 seconds of intubation is performed in both groups, anesthesia with isoflurane at a dose of 2.1% will be And every 45 minutes fentanyl at a dose of 1 μg / kg and atracurium will be repeated every 30 minutes at one-third the initial dose.
In the sections before treatment and also immediately after intubation and during and after the end of surgery, recovery is recorded until transfer to the ward.
Participants/Inclusion and exclusion criteria
Inclusion :
candidate for appendectomy with consent to participate in the evaluation between the ages of 20 and 60 years with ASA class 1 and 2
Exclusion :
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
Intervention groups
The intervention group uses choline succinate for anesthesia.
Main outcome variables
dyspnea
Drug
Oxygen saturation
Duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170404033202N9
Registration date:2022-03-12, 1400/12/21
Registration timing:registered_while_recruiting
Last update:2022-03-12, 1400/12/21
Update count:0
Registration date
2022-03-12, 1400/12/21
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
2021-11-21, 1400/08/30
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Monitoring and comparison of fluctuations in blood oxygen saturation in two methods of induction of anesthesia by priming and succinylcholine in patients undergoing appendectomy
Public title
Monitoring and comparison of fluctuations in blood oxygen saturation in two methods of induction of anesthesia by priming and succinylcholine in patients undergoing appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed and designated appendicitis and a candidate for appendectomy
consent to participate in the evaluation
between the ages of 20 and 60 years
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
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
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
This study will be performed as a two-way blind, in which the patient and the evaluating physician are blinded to the patient group so that the patient knows the plan but does not know in which group and the physician recording the variables does not know the patient group. Depending on whether the patient is in group A (intervention) or B (control), the drugs are different.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Campus of University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.MEDSAB.REC.1400.150
Health conditions studied
1
Description of health condition studied
Comparison of fluctuations in blood oxygen levels in two methods of induction of anesthesia by priming and succinylcholine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of blood oxygen
Timepoint
Before treatment and immediately after surgery, recovery is recorded at intervals of 10 minutes to 3 times until transfer to the ward.
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group receiving succinylcholine for anesthesia.Intervention group: The group receiving succinylcholine for anesthesia in this study in both groups 0.02 mg / kg midarolam and 2 μg / kg fentanyl was given as a premedication and after three minutes in group A5 5 mg / kg sodium Thiopental is given and then scolin is given at a dose of 1.5 mg / kg and after 30 seconds the patient is intubated and then atracurium 0.5 mg / kg is administered in both groups of anesthesia with isoflurane at a dose of 2.1%. And every 45 minutes fentanyl at a dose of 1 μg / kg and atracurium at 30% of the initial dose will be repeated every 30 minutes.
Category
Treatment - Drugs
2
Description
Control group: In this study, in both groups, 0.02 mg / kg midarolam and 2 μg / kg fentanyl were given as pre-medication and after three minutes in group B (control) after pre-medication, 10% dose of atracurium (half mg). / Kg) is prescribed for 4 minutes sodium thio pental at a rate of 5 ml / kg and the rest of the atracorium is administered and after 60 to 90 seconds of intubation is performed in both groups of anesthesia with isoflurane at a dose of 1/2 Will be and every 45 minutes fentanyl at a dose of 1 microgram / kg and atracurium will be repeated every 30 minutes at a rate of one third of the initial dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hosspital
Full name of responsible person
Mohammad Nematshahi
Street address
Sabzevar University of Medical Sciences Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Phone
+98 51 4444 0004
Email
a.asadi.mm.1384@gmail
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad saghee
Street address
Sabzevar University of Medical Sciences Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Phone
+98 51 4444 0004
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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Asadabadi Central Organization of the University
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Phone
+98 51 4422 9081
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 Central Organization of the University
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 Central Organization of the University
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Phone
+98 51 4422 9081
Email
a.asadi.mm.1384@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
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