Opinion: we khnow that the nitrous oxide gas can distend closed gas spaces of the body including stomach.Our opinion in this study is showing that the nitrous oxide gas can increase post operative gastric pain with aggravating laryngeal mask airway induced gastric distension or not? Inclusion criteria: 18-65 years old patients who scheduled for minor eye, orthopedic or general surgeries. Exclusion criteria: history of gasterointestinal problems, emergency operations, full stomach patients and patients with uncontrolled medical illness. Method and sample size: this study will be done on 160 patients with 18-65 years old ages who divide to 2 groups: group A who receive nitrous oxide and group B who won't.The technique of anesthesia is similar in other aspects.The patients will be assessed in post operative period to see whether these two groups are meaningfully different in reporting gastric pain or not?
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010420542N1
Registration date:2015-02-18, 1393/11/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-18, 1393/11/29
Registrant information
Name
Kazem Samadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 7636
Email address
ksamadi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Committee of Shiraz University of Medical Sciences; International Branch
Expected recruitment start date
2015-01-06, 1393/10/16
Expected recruitment end date
2015-02-05, 1393/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nitrous oxide in post operative epigastric pain in the patients underwent general anesthesia with laryngeal mask airway
Public title
The effect of nitrous oxide in post operative abdominal pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The 18-65 years - old patients scheduled for elective and minor eye, orthopedic or general surgeries which generally not exeed 45 minutes.
Exclusion criteria: full stomach patients; emergency setting; trauma; morbid obesity (bmi more than 35); poor ventilation after laryngeal mask airway insertion; laparatomy; contraindication for nitrous oxide consumption; toothless patients; abdominal surgery; any uncontrolled mediical disease; extra dose of atracurium due to insufficient relaxation or prolongation of procedure
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Karimkhane zand Blvrd.
City
Shiraz
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
CT-2014-246
Health conditions studied
1
Description of health condition studied
Abdominal pain
ICD-10 code
R10.1
ICD-10 code description
epigastric pain
Primary outcomes
1
Description
epigastric pain
Timepoint
one hr after operation
Method of measurement
subjective pain score
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group we eliminate nitrous oxide gas from anesthesia drugs.
Category
Other
2
Description
In control group the patients receive nitrous oxide gas as as a routin anesthesia practice.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Marvdasht Shahid Motahhari Hospital
Full name of responsible person
Kazem Samadi
Street address
Shahid Motahhari Hospital, Moallem Square
City
Marvdasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Committee of International Branch of Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Reza Panjeshahin
Street address
Central Office of Iternational Branch of Shiraz University of Medical Sciences, No 24, Jehad sazandegi street, Azadi Square
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Committee of International Branch of Shiraz University of Medical Sciences
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
Shiraz University of Medical Science
Full name of responsible person
Kazem Samadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of anesthesiology, Shahid Faghihi Hospital, Karimkhane zand Blvd.
City
Shiraz
Postal code
Phone
+98 71 3233 7636
Fax
+98 71 3233 7636
Email
samadikazem@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kazem Samadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Shahid Faghihi Hospital, Karimkhane zand Blvd
City
Shiraz
Postal code
Phone
+98 71 3233 7636
Fax
+98 71 3233 7636
Email
samadikazem@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kazem Samadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Shahid Faghihi Hospital, Karimkhane zand Blvd
City
Shiraz
Postal code
Phone
+98 71 3233 7636
Fax
+98 71 3233 7636
Email
samadikazem@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)