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IRCT20141209020258N107 IRCT 2019-04-23 Arak University of Medical Sciences Comparison of the effect of adding Neostigmine to Ropivacaine and sufentanilto Ropivacaine in spinal anesthesia for herniorrhaphy surgery Comparison of the effect of adding Neostigmine to Ropivacaine and sufentanilto Ropivacaine in spinal anesthesia for herniorrhaphy surgery 2019-03-01 anticipated 105 Complete https://irct.ir/trial/38999 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random number table in division of groups in two groups A and B and C Randomization method: Simple randomization. Random unit: Individual. How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group. Allocation concealment:Numbered drug containers, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B and C are available to analyzer and outcome assessor. 2-3 Spinal anesthesia. Intervention 1: Intervention group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 50 micro gram Neostigmine (Caspian.Co.Rasht)(1 milliliter) in form of intrathecal. Intervention 2: Intervention group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 5 micro gram Sufentanil (Aboreihan.Co)(1 milliliter) in form of intrathecal. Intervention 3: Control group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 1 milliliter distilled water (Daropakhsh.Co)(1 milliliter) in form of intrathecal. Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: researcher in university Conditions: If there are additional questions Where to obtain: Dr Modir How to obtain: They have to write letters to the professors and the university Comments:
public Dr Alireza Kamali
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) 18 to 60 years Patients candidate inguinal hernia surgery Lack of cardiovascular problems Absence of coagulation disorders Lack of peripheral and central neuropathy No history of allergy to Neostigmine and Ropivacaine and Sufentanil Non-localized infection in the spinal cord 18 years 60 years Both Patient dissatisfaction Failure to perform spinal anesthesia X64 Intentional self-poisoning by and exposure to other and unspecified drugs, medicaments and biological substances Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 50 micro gram Neostigmine (Caspian.Co.Rasht)(1 milliliter) in form of intrathecal. Intervention group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 5 micro gram Sufentanil (Aboreihan.Co)(1 milliliter) in form of intrathecal. Control group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 1 milliliter distilled water (Daropakhsh.Co)(1 milliliter) in form of intrathecal. Mean arterial blood pressure. Timepoint: Every 15 minutes during surgery and recovery time and up to 2 hours after surgery. Method of measurement: Barometer. Heart rate. Timepoint: Every 15 minutes during surgery and recovery time and up to 2 hours after surgery. Method of measurement: Count. Percent of oxygen saturation. Timepoint: Every 15 minutes during surgery and recovery time and up to 2 hours after surgery. Method of measurement: Pulse oximetry. Duration of motor block. Timepoint: Every 5 minute. Method of measurement: Minute. Duration of Sensory block. Timepoint: Every 1minute. Method of measurement: Minute. Pain. Timepoint: Recovery and 2, 4, 8, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale Questionnaire. Mean of narcotic. Timepoint: 24 hour after surgery. Method of measurement: Milligram. Arak University of Medical Sciences Approved 2019-02-24 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)