Protocol summary

Study aim
Effects of positive expiratory end pressure during general anesthesia with airway laryngeal mask on ventilatory parameters and abdominal pain
Design
In this study, 80 patients between the age of 20 and 70 will be divided into two groups, divided into groups one and two of the American Society of Anesthesiologists (ASA Class I and II) who undergo cataract surgery.
Settings and conduct
The positive effects of expiratory end pressure during general anesthesia with airway laryngeal mask on ventricular parameters and abdominal pain in cataract surgery in Nikokari hospital in Tabriz. In this double-blind study, researchers and data analysts are blind.
Participants/Inclusion and exclusion criteria
All patients aged 20 to 70 years with ASA Class I and II undergoing general anesthesia cataract surgery using a laryngeal mask. Exclusion criteria: - Surgery under local anesthesia - Lung disease - BMI> 30 Patients with obstructive sleep apnea - Patients with a history of gastroesophageal reflux - unwillingness to participate in the study
Intervention groups
For the first group, ventilation of PEEP-free volume control, ie, the current volume of 6 ml / kg based on ideal body weight, with a respiratory rate of 10-8 minutes per minute will begin. And then based on capnography and to maintain EtCo2 between 30 and 35 mmHg, the respiratory rate will change as needed. The second group will be treated exactly the same as the first group plus PEEP at 5 cmH2o. At anesthesia 1, 5, 10 and 20 minutes after anesthesia the peak pressure (PPeak), dynamic complement, expiratory volume, Spo2 (pulse oximetry), non-invasive blood pressure and heart rate will be recorded for all patients by anesthesiologist. . The information displayed on the MEDEC Saturn Evo anesthesia machine will be used to record the above
Main outcome variables
Nausea, headache, back pain, respiratory depression

General information

Reason for update
Acronym
اثرات فشار مثبت
IRCT registration information
IRCT registration number: IRCT20190921044832N1
Registration date: 2019-11-30, 1398/09/09
Registration timing: prospective

Last update: 2019-11-30, 1398/09/09
Update count: 0
Registration date
2019-11-30, 1398/09/09
Registrant information
Name
Jafar Rahimi panahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1994
Email address
panahij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Positive End Expiratory pressure during laryngeal mask airway anesthesia on respiratory parameters and abdominal pain in cataract surgery
Public title
Effects of Positive End Expiratory pressure during laryngeal mask airway anesthesia on respiratory
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 20 to 70 years with ASA Class I and II undergo general anesthesia cataract surgery using a laryngeal mask.
Exclusion criteria:
- Surgery under local anesthesia People with mental disabilities Over 70 years old Under 20 years unwillingness to participate in the study Patients with a history of gastroesophageal reflux Patients with obstructive sleep apnea BMI> 30 Lung disease
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to intervention and control groups will be performed using the random numbered table technique via Randlist online software, individually for patients. In this study, patients were randomly divided into two groups via simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist is responsible for administering the anesthesia, monitoring the patient and preparing study solutions and is not blind to the autopsy. But the students are blind to the data analysis. The student is responsible for collecting patient information and variables.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, Daneshghah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Approval date
2019-10-28, 1398/08/06
Ethics committee reference number
IR.TBZMED.REC.1398.766

Health conditions studied

1

Description of health condition studied
In this study, patients were classified into groups one and two of the ASA Class I and II classifications undergoing cataract surgery.
ICD-10 code
H18.81
ICD-10 code description
Anesthesia and hypoesthesia of cornea

Primary outcomes

1

Description
Hypotension
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
Monitoring, Sphygmomanometer tool

2

Description
Respiratory depression
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
Monitoring, Sphygmomanometer tool

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: the process is exactly similar to control group. The positive end-expiratory pressure will applied with 5cm of H2O. 1, 5, 10 and 20 minutes after giving anesthesia, Peak inspiratory pressure, dynamic compliance, expiratory volume, SpO2 , Pulse oximetry, Noninvasive Blood Pressure and heart rate will be measured and recorded by anesthesiologist for all patients. The information will be displayed on Saturn Evo Anesthesia Machine that is used for recording the data. Recovering from anesthesia the patient will be transferred to recovery room
Category
Treatment - Drugs

2

Description
Control group: accreditation without PEEP, was added to 6 ml / kg and brewed at 5 ml / kg. And further, according to the guidelines of Copnography and EtCo2 support between 30 and 35 mm Hg, please breathe so you can easily change.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Nikokari hospital
Full name of responsible person
Jafar Rahimi Panahi
Street address
Nikokari hospital, َAbasi square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
34424882
Phone
+98 41 3442 4425
Email
panahij@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. abolghasem jouyban
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
3344280 0413
Phone
+98 41 3334 4280
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Jafar Rahimi Panahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No32,University Ave, Opposite the Central Office of Tabriz University of Medical Sciences,Tabriz Town,IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
333333
Phone
+98 914 313 8969
Email
panahij@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jafar Rahimi Panahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No.32,University Ave, Opposite the Central Office of Tabriz University of Medical Sciences,Tabriz Town,IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
9999999999
Phone
+98 914 313 8969
Email
panahij@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jafar Rahimi Panahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No.32,University Ave., opposite the Central Office of Tabriz University of Medical Sciences,Tabriz Town,IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
3345697
Phone
3345697
Email
panahij@tbzmed.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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