This is a triple blind clinical trial, comparing nitrous oxide and carbon dioxide for creating pneumoperitoneum in laparoscopic cholecystectomy to assess relative advantages or disadvantages of these two gases regarding their physiologic effects and side effects. After controlling the inclusion and exclusion criteria and informed consent, 64 patients will assigned randomly to carbon dioxide or nitrous oxide group by block randomization. The patients blindly and with complete concealment, will be operated laparoscopically. The hemodynamic and respiratory parameters (heart rate, mean arterial blood pressure, end-tidal CO2, minute ventilation, and O2 saturation) before pneumoperitoneum and during it will be recorded. Pain, as perceived by patients, is measured 2,4 and 24 hours after the procedure by visual analogue scale. Vomiting and use of analgesics and antiemetics will be recorded and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806092389N1
Registration date:2011-04-22, 1390/02/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-22, 1390/02/02
Registrant information
Name
Mehdi Asgari
Name of organization / entity
Jundi Shapur Medical University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 3050
Email address
asgarime@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundi Shapur Medical University
Expected recruitment start date
2010-07-06, 1389/04/15
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing physiologic consequences and side effects of N2O and CO2 pneumoperitoneum for laparoscopic cholecystectomy
Public title
Use of nitrous oxide for laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:cholelithiasis, suitable for laparoscopic cholecystectomy, informed consent, ASA Score=1&2
exclusion criteria: complicated cholelithiasis including cholecystitis and suppurative cholangitis, complete inability to move, mental disorder percluding communication, pregnancy, known cancer case
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundi Shapur Medical University
Street address
Medical Science School, Shahrak Daneshgahi
City
Ahvaz
Postal code
Approval date
2010-10-23, 1389/08/01
Ethics committee reference number
u-89140
Health conditions studied
1
Description of health condition studied
cholelithiasis
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
heart rate
Timepoint
before and during pneumoperitoneum
Method of measurement
beat per minute with anasthesia monitoring devices
2
Description
mean arterial pressure
Timepoint
before and during pneumoperitoneum
Method of measurement
mmHg as detected by anasthetic monitoring devices
3
Description
End tidal CO2
Timepoint
before and during pneumoperitoneum
Method of measurement
mmHg as detected by anasthetic monitoring devices
4
Description
minute ventilation
Timepoint
before and during pneumoperitoneum
Method of measurement
product of tidal volume and respiratory rate as controlled by anasthetic devices
5
Description
arterial oxygen saturation
Timepoint
before and during pneumoperitoneum
Method of measurement
percent as detected by anasthetic monitoring devices
6
Description
intraoperative complications
Timepoint
from instillation of gas till complete recovery
Method of measurement
as diagnosed by surgeon and anasthesiologist
7
Description
postoperative complications
Timepoint
from transfer of the patient to ward till discharge
Method of measurement
as diagnosed by surgeon and anasthesiologist
8
Description
pain
Timepoint
2, 6 and 24 hour post-operation
Method of measurement
visual analogue scale
9
Description
shoulder pain
Timepoint
every time before discharge
Method of measurement
as declared by patient upon questioning
10
Description
vomiting
Timepoint
every time before discharge
Method of measurement
as declared by patient upon questioning
11
Description
analgesics administered post-oparatively
Timepoint
during admission of the patient
Method of measurement
mg/kg as documented by nurse
12
Description
antiemetics administered postoperatively
Timepoint
during admission of the patient
Method of measurement
mg/kg as documented by nurse
13
Description
ability to move in bed
Timepoint
6 hour post-operatively
Method of measurement
as assessed by researcher
14
Description
ability to move out of bed
Timepoint
6 hour post-operatively
Method of measurement
as assessed by researcher
Secondary outcomes
empty
Intervention groups
1
Description
Use of nitrous oxide for creating pneumoperitoneum in laparoscopic cholecystectomy.
Category
Treatment - Other
2
Description
Use of carbon dioxide for creating pneumoperitoneum in laparoscopic cholecystectomy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Mehdi Asgari, M.D.
Street address
Razi Hospital, Chamran street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundi Shapur Medical University
Full name of responsible person
Mostafa, Feghhi
Street address
University Campus, Vice chancellor or research
City
Ahvaz
Grant name
129006
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundi Shapur Medical University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jundi Shapur Medical University
Full name of responsible person
Mehdi, Asgari
Position
medical school staff, surgeon
Other areas of specialty/work
Street address
Razi Hospital, Chamran Street
City
Ahvaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
asgarime@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundi Shapur Medical University
Full name of responsible person
Mehdi, Asgari
Position
Assisstant professor of surgery
Other areas of specialty/work
Street address
Razi Hospital, Chamran Street
City
Ahvaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
asgarime@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundi Shapur Medical University
Full name of responsible person
Mojtaba, Ahmadzadeh
Position
resident of surgery
Other areas of specialty/work
Street address
Razi Hospital, Chamran Street
City
Ahvaz
Postal code
Phone
+98 61 1391 0339
Fax
Email
mojahmad@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)