The plan of this study is to compare efficacy of sedative and analgesia effect of gabapentin and dexmedetomidine in patients undergoing laparascopic surgery .the study is pilot randomized and open label (not blinded).the 40 patients undergoing laparascopic surgery are under study.
Entry criterion:
Age between 18 and 65
ASA1, 2
Body mass index lower than 28 kg on stature product
Acquire written consent
Exit criterion:
Existence of records in a systemic malady (high blood pressure, ischemic heart, and etc…), allergies records, contraindications of gabapentin and dexmedetomidine
Addiction to drugs and alcohol
Pregnancy
Sample size: 40 patients undergoing laparoscopic surgery
Types of interventions: the first group (control group): gabapentin, 300 mg one hour before surgery
The second group (intervention group): Group II dexmedetomidine 0.5-1 micrograms per patient weight morning before practice.
The primary outcome: anxiety scale measured and checked Ramsay
Secondary outcome: pain measured by VAS scale and checked.
Intervention time: 9 months
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011822794N2
Registration date:2016-03-13, 1394/12/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-13, 1394/12/23
Registrant information
Name
Bahador Bagheri
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 326 8059
Email address
bagherib@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences - Research and development Vice
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sedative and analgesic effect of Gabapentin and Dexmedetomidine in patients undergoing laparoscopic surgery
Public title
Comparison of sedative and analgesic effect of Gabapentin and Dexmedetomidine
Purpose
Treatment
Inclusion/Exclusion criteria
Entry criterion:
Age between 18 and 65
ASA1, 2
Body mass index lower than 28 kg on stature product
Acquire written consent
Exit criterion:
Existence of records in a systemic malady (high blood pressure, all types of collagen disease, ischemic heart, kidney, digestive system and etc…), allergies records, contraindications of gabapentin and dexmedetomidine
Addiction to drugs and alcohol
Pregnancy
Paroxysmal
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences - Research and development Vice
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1394.142
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06
ICD-10 code description
Other mental disorders due to brain damage and dysfunction and to physical disease
Primary outcomes
1
Description
Anxiety
Timepoint
6 hours after intervention
Method of measurement
Ramsay scale
2
Description
Pain
Timepoint
6 hours after intervention
Method of measurement
standard questionnaires VAS
Secondary outcomes
1
Description
Sleep without provocation
Timepoint
6 hours after intervention
Method of measurement
Ramsay scale
Intervention groups
1
Description
The first group gabapentin, 300 mg one hour before surgery
Category
Treatment - Drugs
2
Description
The second group Dax medetomidine 0.5-1 micrograms per patient weight in the morning before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital in Semnan
Full name of responsible person
Abolfaz lAbdollahpoor
Street address
Kowsar Hospital in Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Semnan University of Medical Sciences
Full name of responsible person
Bahador Bagheri
Street address
Semnan University of Medical Sciences
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Abdollahpoor
Position
PHD
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3343 7859
Fax
Email
felordce@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Bahador Bagheri
Position
PHD
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 912 326 8059
Fax
Email
bagherib@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Bahador Bagheri
Position
Assitant professor of pharmacology
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
Fax
Email
bagherib@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)