The current study as a double blind clinical trial will be conducted at Velayat hospital affiliated to guilan university of medical sciences. The aim of this study is to investigate the prophylactic effect of Gabapentin on nausea and vomiting after early excision and graft in patient with burn. A number of 116 patient will be randomly divided into two groups of Gabapentin and control. 2 hours before anesthesia, Gabapantin group will receive 600 mg of gabapantin orally. Anesthesia and surgery will be carried out according to the standard protocol. Nausea and vomiting frequency and severity will be measured at 5 point times ( 0,6,12,18 ,24). Finally the data will be analyzed and compared in 2 groups.
Inclusion criteria:
Age 18 to 60 years old; ASA I&II ;early surgical excision and graft in
Burned patient
Exclusion criteria:
Addiction; smoker; alcoholic patient; use of antiemetic; anti acid; analgesic; anti depressant; ca Chanel blocker; renal and hepatic insufficiency; underlying disease leading to nausea and vomiting; pregnancy; lactating; allergy to gabapentin or opium and motion sickness
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100230072N2
Registration date:2017-05-09, 1396/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-09, 1396/02/19
Registrant information
Name
Siamak Rimaz
Name of organization / entity
Guilan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 8540
Email address
smkrimaz@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
govermental
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate prophylactic effect of Gabapantine on nausea and vomiting after excision and graft in patient with burn
Public title
gabapentine effect on post operative nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years old; ASA I&II ;early surgical excision and graft in
Burned patient
Exclusion criteria:
Addiction; smoker; alcoholic patient; use of antiemetic; anti acid; analgesic; anti depressant; ca Chanel blocker; renal and hepatic insufficiency; underlying disease leading to nausea and vomiting; pregnancy; lactating; allergy to gabapentin or opium and motion sickness
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
116
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 committee of Guilan University of Medical Sciences
Street address
Namjoo ave
City
Rasht
Postal code
4193833697
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.GUMS.REC.1395.113
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
nausea
Timepoint
PACU (T0) 6 hr post surgery (T1) 12 hr post surgery (T2) 18 hr post surgery (T3) 24 hr post surgery (T4)
Method of measurement
vas score
2
Description
vomitting
Timepoint
PACU (T0) 6 hr post surgery (T1) 12 hr post surgery (T2) 18 hr post surgery (T3) 24 hr post surgery (T4)
Method of measurement
frequency
Secondary outcomes
1
Description
pain
Timepoint
PACU (T0) 6 hr post surgery (T1) 12 hr post surgery (T2) 18 hr post surgery (T3) 24 hr post surgery (T4)
Method of measurement
vas
Intervention groups
1
Description
Intervention Group: Oral administration of Gabapantin 600 mg 2hours before anesthesia
Category
Prevention
2
Description
Control Group: No drug
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
anesthesia research center
Full name of responsible person
Dr Siamak Rimaz
Street address
Namjoo Avenue, Velaiat hospital
City
rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Anesthisia research centre
Full name of responsible person
Dr. siamak Rimaz
Street address
Namjoo Avenue, Velaiat hospital
City
rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthisia research centre
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
Guilan university of medical sciences
Full name of responsible person
Dr. Siamak Rimaz
Position
Assistant professor
Other areas of specialty/work
Street address
Namjoo Avenue, research centre, Velaiat hospital
City
rasht
Postal code
Phone
+98 13 1321 0343
Fax
Email
smkrimaz@yahool.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr. siamak Rimaz
Position
Assintant professor
Other areas of specialty/work
Street address
Namjoo Avenue, Deputy department
City
rasht
Postal code
Phone
+98 13 3366 3070
Fax
Email
smkrimaz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr. siamak Rimaz
Position
assistant professor
Other areas of specialty/work
Street address
Namjoo Avenue, research centre, Velaiat hospital
City
rasht
Postal code
Phone
+98 13 3366 3070
Fax
Email
smkrimaz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)