This randomized clinical trial study aims to compare the induction of controlled hypotension by acupuncture point DU.20 electro stimulation and Remifentanil in the patients undergoing laminectomy. General anesthesia is induced in all patients using Fentanil (2 mcg/kg), Propofol (2mg/kg) and Atracurium (0.5 mg/kg) and is maintained using Isoflurane (BIS 40-60). Then the patients are divided into two groups. In the control group, controlled hypotension is induced using Remifentanil added to the other anesthesia drugs and in the case group, electro stimulation of acupoint DU.20 is used instead of Remifentanil. In both groups, in spite of using these methods, if mean arterial pressure (MAP) is above 70 mmHg, Nitroglycerin will be added to the others. In the course of surgery, the hemodynamic variables, bloodlessness scale of surgical field and intraoperative blood loss are recorded and compared between both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509213379N3
Registration date:2015-10-13, 1394/07/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-13, 1394/07/21
Registrant information
Name
Mehdi Ghaemi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1728 9915
Email address
mahiar@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- chancellery for Research of Zanjan University of Medical Sciences
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative induction of controlled hypotension by Acupuncture point DU20 electrostimulation and Remifentanil in lumbar laminectomy
Public title
The effect of Acupuncture on reduction of blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients aged between 20-60 years old and classified as ASA I and ASA II who are candidated for elective laminectomy
Exclusion criteria: The patients who have history of Asthma, cardiovascular, liver and renal diseases and take anticoagulant and aspirin
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:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Zanjan University of Medical Sciences
Street address
Azadi Square
City
Zanjan
Postal code
4515613113
Approval date
2015-09-01, 1394/06/10
Ethics committee reference number
ZUMS.REC.1394.136
Health conditions studied
1
Description of health condition studied
Induced Hypotension
ICD-10 code
195.2
ICD-10 code description
Hypotension due to drugs
Primary outcomes
1
Description
reduction of mean arterial pressure(MAP)
Timepoint
every ten minutes after intervention
Method of measurement
mmHg by blood pressure monitor
Secondary outcomes
1
Description
bloodlessness quality of surgical field
Timepoint
every 30 minutes after intervention
Method of measurement
according to scale adapted from Dolman et al.
Intervention groups
1
Description
Electrostimulation of Acupoint Du20
Category
Treatment - Other
2
Description
infusion of Remifentanil 100 mcg/kg/min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi Hospital
Full name of responsible person
Mehdi Ghaemi
Street address
No.10-5,Kosar14 st., Shahrak Niksazan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-chancellery for research of Zanjan University of Medical Sciences
Full name of responsible person
Mrs. Feizy
Street address
Azadi square
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice-chancellery for research of Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ghaemi
Position
Anesthesoilogist
Other areas of specialty/work
Street address
No.10-5, Kosar 14 st., Shahrak Niksazan
City
Zanjan
Postal code
4515987495
Phone
+98 24 3378 9915
Fax
Email
Ghaemi_mp@yahoo.com, Mahiar@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Mehdi Ghaemi
Position
Anesthesiologist
Other areas of specialty/work
Street address
No.10-5, Kosar 14 st., Shahrak Niksazan
City
Zanjan
Postal code
4515987495
Phone
+98 24 3378 9915
Fax
Email
Ghaemi_mp@yahoo.com, Mahiar@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ghaemi
Position
Anesthesiology
Other areas of specialty/work
Street address
No. 10-5, Kosar14, Shahrak Niksazan
City
Zanjan
Postal code
4515987495
Phone
+98 24 3378 9915
Fax
Email
Ghaemi_mp@yahoo.com, Mahiar@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)