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IRCT2013073114238N1 IRCT 2013-12-20 Dr.Erfan Sedaghat Evaluation of the effect of acupuncture in reducing intraoperative bleeding in rhinoplasty. 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, a randomized clinical trial. 2012-05-21 anticipated 88 Complete https://irct.ir/trial/13877 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: This innovation was first used in the world, Randomization description: computer-generated random number, Blinding description: The acupuncture points and needles were covered by drapes in both groups for 30 minutes to make other members of the team blind to the group assignment of patients. Another anesthesiologist, who was blinded to the treatment group allocation, collected the data during the operations. N/A intra operative bleeding. Intervention 1: 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). Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr.Shahram Samadi
Imam Khomeini Hospital,end of Keshavarz bolvar
Tehran Iran (Islamic Republic of) 149733141 +98 21 6658 1576 shsamadi@yahoo.com Imam Hospital scientific Dr.Shahram Samadi
Imam Khomeini Hospital, end of Keshavarz Bolvar
Tehran Iran (Islamic Republic of) 149733141 +98 21 6658 1576 shsamadi@yahoo.com Imam Khomeini Hospital complex Iran (Islamic Republic of) candidates for primary open rhinoplasty 18 years 45 years Both recent treatment with acupuncture, revision surgery, cardiovascular disease (congestive heart failure, coronary artery disease) , cerebrovascular disease, poorly controlled arterial hypertension, history of renal or hepatic insufficiency, history of drug abuse, the presence of a pacemaker, coagulation disorders, neurological disorders, pregnancy patients taking corticosteroid. Z40-Z54 Persons encountering health services for specific procedures and health care Prevention Prevention Prevention 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) 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. 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. 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. Reduced mean artrial blood presure. Timepoint: After intervention and during surgery. Method of measurement: Monitoring the pressure gauge on mmHg. Improve richmond criteria in Recovery. Timepoint: after surgery and entering the patient to recovery. Method of measurement: Questionnaire Form. Improved patient satisfaction who have congestive problems. Timepoint: when the patient leaving recovery. Method of measurement: Questionnaire Form. Dr.Erfan Sedaghat Approved 2013-11-30 Tehran Univercity of Medical Science Central Department of Tehran univercity, 6th floor, Ghods avenue, Keshavarz Bolvar Tehran Tehran Iran (Islamic Republic of)