Nausea and vomiting are prevalent after laparoscopic cholecystectomy surgery and it is necessary to find a solution to control it. We evaluate the effect of gabapentin in controlling the nausea and vomiting after laparoscopic cholecystectomy surgery. One of the advantages of this drug is that, it is used single- dose and reduces the request of other analgesics. It has some complication such as confusion and moving disorders and rare cases as leucopenia .105 individuals are randomly selected and divided into 3 groups. Plecebo is given to 35 individuals as a control group. The effect of gabapantin 300 mg is assessed on 35 individuals and the effect of gabapantin 600 mg is evaluated on other 35 individuals. All 3 groups are identically anesthetised and are controlled each 2 hours up to 18 hours and the results are listed in checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104042080N5
Registration date:2011-07-22, 1390/04/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-22, 1390/04/31
Registrant information
Name
Afsaneh Norouzi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 7474
Email address
norouzi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak university of medical sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-08-21, 1390/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of gabapentin in controlling the nausea and vomiting after the laparoscopic cholecystectomy surgery
Public title
The effect of gabapentin in controlling the nausea and vomiting after the laparoscopic cholecystectomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the age group of 20-60 years. Exclusion criteria: history of using analgesic and narcotic prior to the surgery; history of chronic lung and heart diseases; history of using corticosteroid; movement disorders; history of smoking; patient who use Gabapentin; history of allergy to gabapentin; people who need N.G tube after exiting the surgery room.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak university of medical sciences
Street address
Alamol hoda street
City
Arak
Postal code
Approval date
2011-03-14, 1389/12/23
Ethics committee reference number
89-102-7
Health conditions studied
1
Description of health condition studied
laparoscopic cholecystectomy
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Nausea
Timepoint
Each 2hour
Method of measurement
Chek list and physical examination and VAS score
2
Description
Vomiting
Timepoint
Each 2 hours
Method of measurement
Chek list and physical examination
Secondary outcomes
1
Description
Motion sickness
Timepoint
Each 2 hours
Method of measurement
Chek list and physical examination
2
Description
Confiusion
Timepoint
Each 2 hours
Method of measurement
Chek list and physical examination
Intervention groups
1
Description
Gabapentin tablet (300 mg) is given to the patient 1 hour before the surgery orally with 100 cc water.
Category
Prevention
2
Description
Gabapentin (600 mg) is given to the patient 1 hour before the surgery orally with 100 CC water.
Category
Prevention
3
Description
The placebo tablet is given to the patient 1 hour before the surgery orally with 100 cc water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr. Afsaneh Norouzi
Street address
Valiasr hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr.Changizi Ashtiyani
Street address
Alamol hoda street
City
Arak
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
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
Arak university of medical sciences
Full name of responsible person
Dr. Afsaneh Norouzi
Position
Asistant professor, Anesthesiologist
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86 1222 4790
Fax
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr. Afsaneh Norouzi
Position
Assistant professor, anesthesiologist
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86 1222 4790
Fax
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Elnaz Rahbari
Position
Medical student
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86 1222 4790
Fax
Email
dr.elena.rahbari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)