The aim of this study is the evaluation of effect of adding dexmedetomidine to bupivacaine on the block in laparotomy surgery. 42 patients undergoing laparotomy referred to Hazrat Rasoul Hospital as a randomized, double-blind, without placebo and without control phase 1-2 trials using random numbers and the method of random block by block 6 each to two groups are divided. Patients must be over 20 years and ASA have one to three patients with intraoperative hemodynamic disturbances, disturbances in consciousness, mechanical ventilation in the postoperative and need to continue after the end of anesthesia isl be excluded. In the first group, in the block site, bupivacaine and dexmedetomidine is injected but only bupivacaine is injected in the second group. The outcome after surgery, total drug intake after surgery, patient satisfaction and complications in each group is be determined and compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121212642N23
Registration date:2015-12-27, 1394/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-27, 1394/10/06
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-03-30, 1394/01/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effect of adding dexmedetomidine to bupivacaine on the block in laparotomy surgery
Public title
The effect of adding dexmedetomidine to bupivacaine in paravertebral block.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I-III; there is no known sensitivity or contraindications for injection of studied drugs; non-prescription tranquilizer in the 24 hours prior to anesthesia; no history of chronic use of opioids or benzodiazepines; no history of liver disease; no history of cardiovascular disease; no history of lung disease; lack the urgency of the surgery.Exclusion criteria: Those who find complicated surgery for any reason; intraoperative hemodynamic disturbances; disturbances in consciousness in the post-operative stage; need to continue mechanical ventilation after the end of anesthesia; complications related to surgery.
Age
From 20 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomisation is performed with using random numbers and the method of random blocks by block 6.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Postal code
Approval date
2014-10-21, 1393/07/29
Ethics committee reference number
93د/105/ 3389
Health conditions studied
1
Description of health condition studied
nerve Block
ICD-10 code
Y48.3
ICD-10 code description
adverse of therapeutic use
Primary outcomes
1
Description
Amount of narcotic of injection
Timepoint
In times of 2, 6, 12, 24 and 48 hours after surgery
Method of measurement
The based on question of the floor nurses and based on milligram
2
Description
Amount of pain
Timepoint
In times of 2, 6, 12, 24 and 48 hours after surgery
Method of measurement
Based on patient state and show the related shaped VAS ruler
Secondary outcomes
1
Description
Amount of Satisfaction
Timepoint
In times of 2, 6, 12, 24 and 48 hours after surgery
Method of measurement
According to the questionnaire, as excellent, good, average, unhappy
Intervention groups
1
Description
In the first group (intervention group) after general anesthesia and completion of the operation, the block identified by ultrasound and bupivacaine 0.25% with a volume of 20 cc with a dose of 100 microgram dexmedetomidine is injected.
Category
Treatment - Other
2
Description
In the second group (control group) after general anesthesia and completion of the operation, the block identified by ultrasound and bupivacaine 0.25% with a volume of 20 cc without dexmedetomidine is injected.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Farnad Imani
Street address
Hazrat Rasool Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Alijavad Musavi
Street address
Vice chancellor for research of Iran University of Medical Sciences, Hemmat Highway
City
Tehran
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, Iran 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
Anesthesiology group of Iran University of Medical Science
Full name of responsible person
Farnad Imani
Position
Fellowship of pain
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Satarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 5001
Fax
Email
Farimani@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology group of Iran University of Medical Science
Full name of responsible person
Farnad Imani
Position
Fellowship of pain
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Satarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 5001
Fax
Email
farimani@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology group of Shahid beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)