Comparison of ventilation prognosis and respiratory problems in two methods of intravenous and inhalation anesthesia
Design
Clinical trial without control group, parallel groups, double blind, randomized with 60 patients
Settings and conduct
Patients undergoing bariatric surgery at Rasool Akram hospital are randomly assigned to two groups. Participants and outcome assessor will also not be aware of the intervention types.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 17 to 50 years, Not having co-morbidity disease, No smoking, No alcohol consumption, BMI>40 and Duration of surgery less than 4 hours, consent to participate the study. Exclusion criteria: Having chronic obstructive pulmonary disease (COPD), having intestines adhesion
Intervention groups
Group 1: Intravenous Anesthesia, Group 2: Inhaled Anesthesia
Main outcome variables
Dead space/tidal volume ratio (VD/VT)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180723040570N4
Registration date:2020-01-30, 1398/11/10
Registration timing:registered_while_recruiting
Last update:2020-01-30, 1398/11/10
Update count:0
Registration date
2020-01-30, 1398/11/10
Registrant information
Name
Nasim Nikoubakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 9854
Email address
nikoobakht.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the dead space/tidal volume in intravenous anesthesia and inhaled anesthesia in morbid obesity undergoing bariatic surgery
Public title
Difference of the dead space/tidal volume in intravenous anesthesia and inhaled anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 17 to 50 years
BMI>40
Duration of surgery less than 4 hours
Consent to participate in the study
Exclusion criteria:
Having chronic obstructive pulmonary disease (COPD)
Having intestines adhesion
Smoking
Alcohol consumption
Age
From 17 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly divided into intervention and control groups using a lottery method. As the names of all participants are placed inside the container. The names are drawn out from the container, respectively, and placed in the intervention and control groups. At the end, the papers containing the names are opened and different groups are determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome assessor will not aware of the intervention because patients are unable to detect the type of anesthesia after anesthesia, and a vein line is established for both groups. The outcome assessor (in the recovery room) is unaware of the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemat Highway ,Tehran
City
تهران
Province
Tehran
Postal code
14496-14535
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.IUMS.FMD.REC.1398.130
Health conditions studied
1
Description of health condition studied
Bariatric surgery
ICD-10 code
Z98.84
ICD-10 code description
Bariatric surgery status
Primary outcomes
1
Description
Dead space to tidal volume ratio (VD/VT)
Timepoint
Before anesthesia and during anesthesia
Method of measurement
Ventilator monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intravenous Anesthesia. In this group, premedication with 0.05 mg / kg midazolam and 3 mcg / kg fentanyl and induction with 5mg / kg thiopental and 0.3 mg / kg cisatracurium will be performed. Also, the maintenance will be done with 100 mcg / kg propofol.
Category
Treatment - Surgery
2
Description
Intervention group 2: Inhaled anesthesia. In this group, premedication with 0.05 mg / kg midazolam and 3 mcg / kg fentanyl and induction with 5mg / kg thiopental and 0.3 mg / kg cisatracurium will be performed. Also, the maintenance will be done with one minimum alveolar concentration (MAC).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Nasim Nikoobakht
Street address
Satarkhan St,Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
nnikobakht@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyad Abbas Motavalian
Street address
Hemat ave.Iranuniversity of medical sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
amotevalian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Nasim Nikoobakht
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hemat ave.Iranuniversity of medical sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
nnikobakht@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Nikoobakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hemat ave.Iranuniversity of medical sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
nnikobakht@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Nikoubakht
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram, Maziar Mansory Ave, Satarkhan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 64351
Email
Nikoobakht.n@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All individual data of the participants in this study will be shared after unidentifiable individuals
When the data will become available and for how long
The access period will start from 2020 to 2022
To whom data/document is available
Data will be available to researchers working in the university
Under which criteria data/document could be used
Scientific responsible should be received email request for research purposes. Of course, the email must be sent by an academic email.
From where data/document is obtainable
To access the data, forward email to nnikobakht@yahoo.com
What processes are involved for a request to access data/document
The data will be available one month after the responsible person's approval