Comparison of the effect of arterial carbon dioxide pressure and nausea, vomiting and pain after laparoscopic cholecystectomy
Design
The study will be double blind and clinical trial. Sixty patients will be randomly divided into 2 groups. The groups are parallel.
Settings and conduct
Patients undergo laparoscopic cholecystectomy in Valiasr Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 65 years old; ASA class one and two; candidate for laparoscopic cholecystectomy surgery; no chronic use of narcotic drugs, NSAIDs, and benzodiazepines.
Exclusion criteria: change of laparoscopic surgery to open surgery; prolongation of the operation time more than 3 hours; need for blood transfusion during the operation; lack of consent to continue participating in the study.
Intervention groups
The first intervention group: in one group, patients will receive standard CO2 gas pressure (14-15 mmHg) during surgery.
The second intervention group: In the second group, they will receive low pressure CO2 gas (7-9 mm Hg).
Main outcome variables
HCO3; PH; PCo2; incidence and severity of nausea and frequency and vomiting score and pain intensity at the operation site; amount of ondansetron and dose of pethidine used; shoulder pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N185
Registration date:2023-05-30, 1402/03/09
Registration timing:prospective
Last update:2023-05-30, 1402/03/09
Update count:0
Registration date
2023-05-30, 1402/03/09
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-06, 1402/03/16
Expected recruitment end date
2023-06-06, 1402/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of arterial carbon dioxide pressure and nausea, vomiting and pain after laparoscopic cholecystectomy
Public title
Comparison of the effect of arterial carbon dioxide pressure and nausea, vomiting and pain after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18 to 65 years old
ASA class I and II
Candidate for laparoscopic cholecystectomy surgery
No chronic use of narcotics, NSAIDs and benzodiazepines
Exclusion criteria:
Changing laparoscopic surgery to open surgery
Extending the operation time more than 3 hours
The need for blood transfusion during the operation
Dissatisfaction to continue attending the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into2 groups using a permuted balanced block randomization method with the size of blocks 4. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the double-blindness of the study, the patients and the data collector (intern) do not know about the groupings, but the anesthesiologist who is on the patient's bed during surgery knows about the groupings.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2023-04-16, 1402/01/27
Ethics committee reference number
IR.ARAKMU.REC.1402.014
Health conditions studied
1
Description of health condition studied
Laparoscopic cholecystectomy
ICD-10 code
K91.86
ICD-10 code description
Retained cholelithiasis following cholecystectomy
Primary outcomes
1
Description
Arterial blood gas
Timepoint
The beginning of the action and the end of the action
Method of measurement
Blood test
2
Description
Nausa
Timepoint
From the time of entering recovery and every 15 minutes to one hour and 2, 4, 8, 12 and 24 hours after surgery.
Method of measurement
Physical examination
3
Description
vomitting
Timepoint
From the time of entering recovery and every 15 minutes to one hour and 2, 4, 8, 12 and 24 hours after surgery.
Method of measurement
Physical examination
4
Description
Pain
Timepoint
Recovery and 4 hours after surgery
Method of measurement
Visual analog scale of pain
5
Description
Mean Ondansetron
Timepoint
At the end of the study
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: in one group, patients will receive standard CO2 gas pressure (14-15 mmHg) during surgery.
Category
Treatment - Surgery
2
Description
The second intervention group: In the second group, they will receive low pressure CO2 gas (7-9 mm Hg).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Behnam Mahmodie
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
salehi@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street