Comparative effects of acupuncture and placebo acupuncture in reducing intraoperative bleeding in open rhinoplasty surgery in patients 18 to 45 years, ASA class1 in Vali Asr Operation Room, Imam Khomeini Hospital 1390-91 years
The purpose of this study,was to evaluate the effect of acupuncture in reducing intraoperative bleeding during open rhinoplasty surgery. In this study patients with ASA class 1 undergoing Open Rhinoplasty Surgery in Valiasr Operating Room, are divided into case and control and group.patients are selected compliance with the inclusion criteria and exclusion criteria.Inclusion criteria for this study patients who are 18 to 45 years and candidates for rhinoplasty surgery included ASA Class 1. Exclusion Criteria: Patients who are younger than 18 or older than 45 ; ASA class more than 1 ; have an underlying coagulopathy or previous heart attack or high blood pressure ; Have kidney or liver disease, or patients with blood system pathology hemoglobin is less than 10.each group consist of 44 patients who are selected randomly and double blind.in case group after Informed consent from patients additional to induced hypotension with Remifentanil and Propofol, Acupuncture of foot acupuncture points have been detected by the Acuhealth device also will be used.in control group patients are just routinely treated by induced hypotension and then indications such as Surgeon satisfaction,Increasing the weight of the sterilized gauze used in the field of surgery, blood volume in the suction and hemoglobin levels before and after surgery in both groups are considered to investigate the effect of acupuncture in reducing intraoperative bleeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013073114238N1
Registration date:2013-12-20, 1392/09/29
Registration timing:retrospective
Last update:
Update count:1
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Erfan Sedaghat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 3382
Email address
e-sedaghat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of acupuncture and placebo acupuncture in reducing intraoperative bleeding in open rhinoplasty surgery in patients 18 to 45 years, ASA class1 in Vali Asr Operation Room, Imam Khomeini Hospital 1390-91 years
Public title
Evaluation of the effect of acupuncture in reducing intraoperative bleeding in rhinoplasty.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: individuals 18 to 45 years who are candidates for rhinoplasty surgery ; ASA Class 1
Exclusion Criteria: Patients who are younger than 18 or older than 45 ; ASA class>1 ; have an underlying coagulopathy or previous heart attack or high blood pressure ; Have kidney or liver disease, or patients with blood system pathology hemoglobin is less than 10 patients receiving aspirin or medicines ; patients who have drug or alcohol abuse ; patients who do not consent to enter the study.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
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 Univercity of Medical Science
Street address
Central Department of Tehran univercity, 6th floor, Ghods avenue, Keshavarz Bolvar
City
Tehran
Postal code
Approval date
2013-11-30, 1392/09/09
Ethics committee reference number
92/د/130/1954
Health conditions studied
1
Description of health condition studied
intra operative bleeding
ICD-10 code
Z40-Z54
ICD-10 code description
Persons encountering health services for specific procedures and health care
Primary outcomes
1
Description
intra operative bleeding
Timepoint
Immediately after intervention
Method of measurement
gauze surgical weight with a digital scale and measuring goats milligrams per milliliter of blood volume in the suction and hemoglobin levels before and after surgery and surgeon satisfaction questionnaire
Secondary outcomes
1
Description
reduced mean artrial blood presure
Timepoint
After intervention and during surgery
Method of measurement
Monitoring the pressure gauge on mmHg
2
Description
Improve richmond criteria in Recovery
Timepoint
after surgery and entering the patient to recovery
Method of measurement
Questionnaire Form
3
Description
improved patient satisfaction who have congestive problems
Timepoint
when the patient leaving recovery
Method of measurement
Questionnaire Form
Intervention groups
1
Description
In all three groups of Method of anesthesia is General Anesthesia and endotracheal intubation .after prepare and Preoxygenation premedication drug Midazolam 0.015 -0.05 mg / kg and opioid (usually Fentanyl (1-2mcg/kg administration and then Intravenous anesthetic Propofol 2 mg / kg and muscle relaxants (Atracurium 0.5-0.6 mg / kg) is administered and intubation with Appropriately sized endotracheal tube is performed.maintanance of anesthesia for all patients, in addition to a percentage of Isoflurane gas inhalation infusion of Ringer ml 1000, induced hypotension with Remifentanil infusion syringe pump at a dose of 0.5 mcg / kg / min and Propofol 50mcg/kg/min. oxygen and nitrous oxide 50:50 with and Atracurium 10 mg will be given 30 minutes to complete anesthesia. Applied to all patients 1 to 2 mL of 1% lidocaine solution impregnated Adrenaline 1 in 200,000 in the lateral wall nose before surgery by the surgeon will inject.Group I: Patients with induced hypotension to control bleeding only routine infusion (propofol and remifentanil) are used to them. (Contro group)
Category
Prevention
2
Description
in case group:
. For medical treatment Acupuncture in point of LIV-3, SP-1, ST-45, BL-67 with special Disposable Needle Acupuncture CE0197 and FDA certification mark licensed HUANQIU No. 25 will 510K.011242 numbers. Looking for
This points out the PRO900 ACUHEALTH TENS device CE0120 certificate and FDA approval of Australia
Will be used.
Category
Prevention
3
Description
Blinding of the surgeon in order to make acupuncture channel points out that By Acuhealth have been identified as areas outside of the channel by the same faculty member with a needle anesthesia Are stimulated.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Operation Room,Iimam Khomeini Hospital
Full name of responsible person
Dr.Erfan Sedaghat
Street address
3th floor, no 7, Hamsyan Streat, Sadoghi Avenue, north jamalzadeh, tehran, iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr.Erfan Sedaghat
Full name of responsible person
Dr.Erfan Sedaghat
Street address
Imam Khomeini Hospital,end of Keshavarz bolvar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr.Erfan Sedaghat
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
Imam Hospital
Full name of responsible person
Dr.Shahram Samadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital,end of Keshavarz bolvar
City
Tehran
Postal code
Phone
+98 21 6658 1576
Fax
Email
shsamadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Dr.Shahram Samadi
Position
feculty
Other areas of specialty/work
Street address
Imam Khomeini Hospital, end of Keshavarz Bolvar
City
Tehran
Postal code
Phone
+98 21 6658 1576
Fax
Email
shsamadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Dr. Erfan Sedaghat
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini Hospital, end of Keshavarz Bolvar
City
Tehran
Postal code
Phone
+98 21 6658 1576
Fax
Email
e-sedaghat@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)