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IRCT20141209020258N118 IRCT 2019-07-27 Arak University of Medical Sciences Comparison of the effects of administration of intrathecal dexmedetomidine and fentanyl ‎and magnesium sulfate as adjuvant to ropivacaine in duration and onset of sensory and ‎motor block in lower abdominal surgery Comparison of the effects of administration of intrathecal dexmedetomidine and fentanyl ‎and magnesium sulfate as adjuvant to ropivacaine in duration and onset of sensory and ‎motor block in lower abdominal surgery 2019-03-06 anticipated 90 Complete https://irct.ir/trial/39035 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in two groups A and B and C.‏ In this method, we selected a number of cards or letters as an intervention group1 and the same ‎number of cards for intervention group 2 and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size.‏, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer and participants are blind (double blind).Outcome assessor and analyzer and participants 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 lower abdominal surgery. Intervention 1: Intervention group: We will inject 3 milliliter (15 milligram) Rupivacaine plus 10 micro gram Dexmedetomidine (1 milliliter) Intrathecal. Intervention 2: Intervention group: We will inject 3 milliliter (15 milligram) Rupivacaine plus 50 micro gram Fentanyl (1 milliliter) Intrathecal. Intervention 3: Intervention group: We will inject 3 milliliter (15 milligram) Rupivacaine plus 1 milliliter Magnesium sulfate 20 %(200 milligram) 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 Valiasr Hospital, Valiasr squre, Shahid Shirodi street 3814957558 How to obtain: Contact With Dr Modir at the following email address. modir.he@gmail.com Comments:
public Dr Afsaneh Noruzi
Valiasr Hospital, Valiasr square, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3471 3638 dr.noruzi@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr square, 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 lower abdominal surgery Lack of body mass index less than 30 18 years 60 years Both Failure to perform spinal anesthesia Dissatisfaction History of taking beta-blockers and alpha-2 calcium channel blockers and blockers Cardiovascular problems Arrhythmia Mental and psychological problems Peripheral and central neuropathy Y61.0 During surgical operation Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: We will inject 3 milliliter (15 milligram) Rupivacaine plus 10 micro gram Dexmedetomidine (1 milliliter) Intrathecal. Intervention group: We will inject 3 milliliter (15 milligram) Rupivacaine plus 50 micro gram Fentanyl (1 milliliter) Intrathecal. Intervention group: We will inject 3 milliliter (15 milligram) Rupivacaine plus 1 milliliter Magnesium sulfate 20 %(200 milligram) Intrathecal. Mean arterial blood pressure. Timepoint: Every 15 minutes during surgery and recovery time. Method of measurement: Digital sphygmomanometer. Heart rate. Timepoint: Every 15 minutes during surgery and recovery time. Method of measurement: ECG. Percent of oxygen saturation. Timepoint: Every 15 minutes during surgery and recovery time. Method of measurement: Pulse oximetry. Duration of motor block. Timepoint: Every 5 minute. Method of measurement: chronometer. Duration of sensory block. Timepoint: Every 1 minute. Method of measurement: chronometer. Pain. Timepoint: Recovery and 1, 2, 4, 6,12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale Questionnaire. Mean of narcotic. Timepoint: 24 hour after surgery. Method of measurement: Observation amount of opiate consumed. Arak University of Medical Sciences Approved 2019-03-06 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)