Evaluation of the relationship between end tidal carbon dioxide pressure and the incidence of severe nausea and vomiting after general anesthesia in laparoscopic cholecystectomy
Evaluation of the relationship between end-expiratory carbon dioxide pressure and the incidence of severe nausea and vomiting after general anesthesia in laparoscopic cholecystectomy
Design
Randomized three-way parallel blind group clinical trial on 88 patients Randomized allocation software was used for randomization
Settings and conduct
The operating room and recovery ward of Al-Zahra and Kashani hospitals are blindfolded with a researcher, outcome assessor and participant.
Participants/Inclusion and exclusion criteria
88 candidates for laparoscopic cholecystectomy with ASA1,2 in the age group of 18-65 years No history of motion sickness and no history of postoperative nausea and vomiting as well as insensitivity to anesthesiaExclusion criteria are: severe intraoperative hemodynamic disorders that lead to a change in anesthesia and failure to complete the questionnaire after surgery.
Also in case of allergy to anesthetic drugs in those who are undergoing surgery for the first time
If the operation lasts longer, it will be removed from the study after 2 hoursNon-admission: Patients with ASA 3 and 4 and severe underlying diseases such as heart failure, COPD, ESRD
Intervention groups
Intervention group: The first group of people undergoing laparoscopic cholecystectomy with a capnograph to maintain the level of carbon dioxide at the end of exhalation between 40-40 mm Hg,The second group of people undergoing laparoscopic cholecystectomy with a capnograph to maintain the level of carbon dioxide at the end of exhalation between 40-40 mm Hg
Main outcome variables
Frequency and severity of nausea and vomiting after surgery. Severe pain. Blood pressure. Antiemetic drug. Drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210503051169N1
Registration date:2021-07-17, 1400/04/26
Registration timing:registered_while_recruiting
Last update:2021-07-17, 1400/04/26
Update count:0
Registration date
2021-07-17, 1400/04/26
Registrant information
Name
mahdi mianji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3661 7278
Email address
mahdimianji313@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-16, 1400/04/25
Expected recruitment end date
2021-08-16, 1400/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the relationship between end tidal carbon dioxide pressure and the incidence of severe nausea and vomiting after general anesthesia in laparoscopic cholecystectomy
Public title
Evaluation of the relationship between end tidal carbon dioxide pressure and the incidence of severe nausea and vomiting after general anesthesia in laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
88 candidates for laparoscopic cholecystectomy with ASA1,2 in the age group of 18-65 years
Exclusion criteria:
Patients with ASA 3 and 4
Severe underlying disease such as heart failure, COPD, ESRD
History of motion sickness and history of postoperative nausea and vomiting
Allergy to anesthesia
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence (blocking) is generated by the help of Excel software and blocks of four are used to equalize the two groups so that the groups 1 and 2 of each person included in the study, can be determined randomly and equally. The blocks of four are separated from the samples and placed in the block randomly by the Excel software of group A or B. At the end, it is determined which letter represents the intervention group 1 and 2.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participant (patient) is not aware of which group they are in. The clinical caregiver adjusts the capnograph to one of two groups according to the randomization.
Without knowing the grouping of people after the operation, the evaluator completes the outcome with a questionnaire without personal information. The questionnaires are given to the researcher in the form of A and B who do not know which is the first or second group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Evaluation of the relationship between end tidal carbon dioxide pressure and the incidence of severe nausea and vomiting after general anesthesia in laparoscopic cholecystectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining and comparing the frequency of postoperative nausea and vomiting in two groups with expiratory end carbon dioxide pressure of 40-40 and 40-45
Timepoint
Every 15 minutes in recovery 2, 4 and 6 hours after surgery
Method of measurement
Through a questionnaire
2
Description
Determining and comparing the average dose of antiemetic drugs in two groups with expiratory carbon dioxide pressure of 40-40 and 45-40
Timepoint
At recovery time 2, 4 and 6 hours after surgery
Method of measurement
Through a questionnaire
3
Description
Determining and comparing the average dose of opioids in two groups with expiratory end carbon dioxide pressure of 35-40 and 40-45
Timepoint
At recovery time 2, 4 and 6 hours after surgery
Method of measurement
Through a questionnaire
4
Description
Determination and comparison of pain intensity during recovery in two groups with expiratory end of carbon dioxide pressure of 35-40 and 40-45
Timepoint
2, 4 and 6 hours after surgery
Method of measurement
Based on VAS
5
Description
Determining and comparing the average level of patient satisfaction in two groups with expiratory end carbon dioxide pressure of 40-40 and 45-40
Timepoint
In 6 hours after surgery
Method of measurement
Based on VAS
Secondary outcomes
1
Description
Determination and comparison of mean arterial blood pressure, oxygen saturation and heart rate in two groups with expiratory end carbon dioxide pressure of 40-40 and 45-40
Timepoint
Basically then every half hour during surgery and recovery
Method of measurement
Through a questionnaire
2
Description
Determining and comparing the duration of anesthesia and the duration of recovery surgery (duration of extubation) in two groups with expiratory end carbon dioxide pressure of 35-40 and 40-45
Timepoint
end of surgery
Method of measurement
Through a questionnaire
Intervention groups
1
Description
Intervention group: The first group of people undergoing laparoscopic cholecystectomy, which is maintained by a capnograph of the end-tidal carbon dioxide level between 35-40 mm Hg.
Category
Treatment - Other
2
Description
Intervention group: The second group of people underwent laparoscopic cholecystectomy, which is maintained by a capnograph of the end-tidal carbon dioxide level between 40-45 mm Hg.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital of Isfahan
Full name of responsible person
Dr.Khosro Naghibi
Street address
Sefeh Blvd, alzahra hospital
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
DR.Khosro Naghibi
Street address
Kashani St, Kashani Hospital
City
Esfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Khosro Naghibi
Street address
Hezar Jerib St., Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
jims@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
40
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Khosro Naghibi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 17, Hezar Jarib St., Sepahan Alley, 6th St.
City
Esfahan
Province
Isfehan
Postal code
8175675333
Phone
+98 31 3670 2548
Email
khnaghibi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Khosro Naghibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 17, Hezar Jarib St., Sepahan Alley, 6th St.
City
Esfahan
Province
Isfehan
Postal code
8175675333
Phone
+98 31 3670 2548
Email
khnaghibi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Khosro Naghibi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 17, Hezar Jarib St., Sepahan Alley, 6th St.
City
Esfahan
Province
Isfehan
Postal code
8175675333
Phone
+98 31 3670 2548
Email
khnaghibi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only registered marks can be published without mentioning the names of the participants
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Written request by e-mail and approval of the Vice Chancellor for Research
From where data/document is obtainable
By correspondence with the responsible author via email
What processes are involved for a request to access data/document
The applicant will be notified within one week of receiving the consent from the university,Maximum access takes 10 business days