Comparison of low pressure versus high pressure gas injection at abdominal cavity on post operative nausea &vomiting after laparoscopic cholecystectomy.
Post operative nausea & vomiting( PONV) is distressing complication of anesthesia and surgery,with a relatively high incidence in women undergoing laparascopic cholesystectomy.therefore,this study aimed to investigate occurrence and severity of PONV of low pressure(LP[8mm/Hg]) in comparison to standard pressure (SP[13mm/Hg]) pneumoperitoneum.Fifty consecutive patients qualified for elective laparascopic cholecystectomy were randomly allocated to either SP group (n=25) &LP group (n=25) , after categorized in similar age grou,provided that they belonged to class 1-2 of ASA. On the day before surgery,patients were ask to provide a detailed medical history,including any history of PONV or motion sickness,smoking habits any any other questions.antiemetic prophylaxis was not recieved.
At first patients will be anesthetized with the followingmedications; midazolam 1-2mg , fentanyle 2 mcg/kg , thiopental 3-5 mg/kg & cisatracurium 0.1 mg/kg. At surgical time,patients were monitired & assessed for BP & HR ,after surgery they were assessed for emetic symptoms within the first post operative 24 h (at five differ times). So all of the obtained information have been compaired in two group (LP& SP).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013013112320N1
Registration date:2013-11-05, 1392/08/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-05, 1392/08/14
Registrant information
Name
Nader Hamoonpou
Name of organization / entity
Ahwaz Jundishapour Medical Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 986112220168
Email address
hamoonpou.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapour University of Medical Sciences.
Expected recruitment start date
2012-12-30, 1391/10/10
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of low pressure versus high pressure gas injection at abdominal cavity on post operative nausea &vomiting after laparoscopic cholecystectomy.
Public title
Assessment of the effect of intra abdominal pressure during operation on nausea & vomiting after laparoscopic cholecystectomy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Elective operation; female patients with the ASA 1-2.
Exclusive criteria: Pregnancy; antiemetic drugs consumption at 24 hours before surgery; motion sickness disease; history of frequent nausea & vomiting for any reason; history of migraine or vertigo; smokers patients; use of Dexamethason or Gabapenthin before surgery for any reason; when excuesion of surgery or its condition have been changed"prolonged procedure or changing of surgical plan"for example: laparoscopy converts to laparatomy.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Jundishapour University of Medical Sciences , Vice Chancellory for Research & Technology Developemen
Street address
Vice Chancellory for Research & Technology Developement , Ahwaz Jundishapour Medical Scienses , Esfand Aven. , Golestan boulevard .
City
Ahwaz
Postal code
6135715794
Approval date
2012-12-22, 1391/10/02
Ethics committee reference number
EPH-675
Health conditions studied
1
Description of health condition studied
Nausea & Vomiting after laparascopic Cholesystectomy
ICD-10 code
K91.0
ICD-10 code description
Nausea & Vomiting , Following Gastrointestinal Surgery.
Primary outcomes
1
Description
Nausea after Laparascopic Cholecystectomy
Timepoint
Recovery ( time 0 ) - 4 - 8 - 12 & 24 hours
Method of measurement
Patient symptoms consistent with graded scale of one to five
2
Description
Vomiting after Laparascopic Cholesystectomy
Timepoint
Recovery ( time 0 ) - 4 - 8 - 12 & 24 hours
Method of measurement
Patient symptoms consistent with graded scale of one to five
Secondary outcomes
empty
Intervention groups
1
Description
At group 1 patients recieve induction with drugs without antiemetic effects then from the surgeon will be asked to do laparascopic cholecystectomy with the least amount of gas injection into the abdominal cavity ,to conclude that to postoperative nausea & vomiting ,be compared with the other patient at group 2 that had been operated with high gas pressure.
Category
Early detection
2
Description
At group 2 patients recieve induction with drugs without antiemetic effects then from the surgeon will be asked to do laparascopic cholecystectomy with the maximum of standard pressure of gas injection into the abdominal cavity,to conclude that to postoperative nausea & vomiting,be compared with the other patients at group 1 that had been operated with low gas pressure.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Aria Hospital
Full name of responsible person
Nader Hamoonpou
Street address
Eastern 18 , Kianpars Aven.
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapour University of Medical Sciences Vice Chancellory for Research and Technology Development
Full name of responsible person
mostafa feghhi
Street address
Vice Chancellory for Research and Technology Development, Ahwaz Jundishapour Medical University
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapour University of Medical Sciences Vice Chancellory for Research and Technology Development
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
Ahwaz Jundishapour University of Medical Scienses
Full name of responsible person
Nader Hamoonpou
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Azadegan Avenue
City
Awaz
Postal code
6193673166
Phone
+98 61 1336 7571
Fax
Email
hamoonpou.nader@Gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Nozar Nassajian
Position
Assistant Professor
Other areas of specialty/work
Street address
Golestan Hospita , Golestan Boulevard
City
Ahwaz
Postal code
6135733118
Phone
+98 61 1374 3037
Fax
Email
nozar_dr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundishapour University of Medical Scienses
Full name of responsible person
Nader Hamoonpou
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Azadegan Avenue
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1374 3037
Fax
Email
hamoonpou.nader@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)