After obtaining written informed consent ,elective ASA class I,II patients candidate for tympanomastoidectomy aged between 20-60 were randomely enroll ed to one of four study groups according to block randomization. Medical intervention was done 1hr before surgery as following in each group. Patients in the gabapentin group received 800mg Gabapentin (2 oral capsules) with 2cc sterile water intravenously (IV), in the second group patients received 8mg dexametasone( IV) with placebo (2 oral capsules similar gabapentin) . Third group participants received 800 mg gabapentin plus 8mg dexametasone( IV).The final group patients received placebo (2 oral capsules similar gabapentin) with 2 cc sterile water (IV).Patients in all groups underwent general anesthesia in the same manner, consisting of premedication with fentanyl 2µg/Kg,midazolam 2mg, followed by induction dose of sodium thiopental(5mg/kg) and atracurium o.6 mg/kg. After intubation anesthesia were maintained by isoflorance 0/5% + propafol 50 μg / kg /m + remifentanyl (0.1µg/kg/min). Degree of nausea and vomitting is assessed until 24 hours post-operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208075225N2
Registration date:2012-08-20, 1391/05/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-08-20, 1391/05/30
Registrant information
Name
Seyed mohammad Mireskandari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 8931
Email address
mireskandari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Terhan University of Medical Sciencs
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of antiemetic effects of gabapentin and dexametason in patient who are candidates of middle are surgery
Public title
Comparison of antiemetic effects of gabapentin and dexametason in patient who are candidates of middle are surgery in the year2012 in Valiasr hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients scheduled for Tympanomastoidectomy under general anesthesia; ASA class I,II patients; patients aged between 20-60 years.
Exclusive criteria : prior history of PONV; smokers; hypersensitivity to any of study drugs; serious organ disease/dysfunction; persistent preoperative pain; prior use of analgesic; alcohol/substance abuse; a major psychiatric disorder; a bleeding disorder; peptic ulcer disease; asthma/COPD and a seizure disorderl; patients who had received anti emetics within 24 hr before scheduled surgery or received sedatives (7, 8) and duration of operation more than 3 hours.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
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
Tehran University of Medical Sciences Ethics Committee
Street address
Keshavarz Boulvard ,Tehran
City
Tehran
Postal code
Approval date
2011-04-19, 1390/01/30
Ethics committee reference number
90/130/141
Health conditions studied
1
Description of health condition studied
Vomiting
ICD-10 code
Z40-54
ICD-10 code description
Persons encountering health services for specific procedures and health care
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Frequency of Nausea & vomiting during 24 hours post-operation
Method of measurement
According to self report of patients
Secondary outcomes
empty
Intervention groups
1
Description
Patients in combination group recieve 2 capsule of gabapentin and 8 mg dexamethasone (2cc) intravenousely
Category
Treatment - Drugs
2
Description
Medical intervention was done 1hr before surgery as following in each group. Patients in the gabapentin group received 800mg Gabapentin (2 oral capsules) with 2cc saline normal intravenously (IV
Category
Treatment - Drugs
3
Description
Patients in dexamethasone group recieved 8 mg dexamethasone(2 cc) intravenousely and 2 placebo capsule identical to gabapentin.
Category
Treatment - Drugs
4
Description
In control (placebo) group patients recieve 2 cc normal saline intravenousely and 2 placebo capsules orally
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital, Imam Khomeini Complex
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research of Tehran university of medical sciences
Full name of responsible person
Akbar Fotoohi
Street address
Office of TUMS Public Relations, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research of Tehran university of medical sciences