]>
IRCT20190114042358N3 IRCT 2020-04-23 Tabriz University of Medical Sciences Dexmedetomidine sedation in awake caudal block for lower abdominal surgeries in neonates Dexmedetomidine sedation in awake caudal block for lower abdominal surgeries in neonates 2019-04-21 anticipated 100 Complete https://irct.ir/trial/47302 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random method: Block, Random unit: individual, Random Tool: Random Block 4. for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, dice drooped and the block number will be selected. this procedure continued to completed the allocation and reached to sample size, Blinding description: This is a double-blinded study and Researcher and patients are kept unaware of intervention in each group and In order to allocation concealment, the type of intervention will be written on paper and placed in numbered, matte and packed envelopes.The envelopes will be opened in the order of participation of the participants and the type of group will be determined. 2 caudal block(Local anaesthetics). Intervention 1: Intervention group: neonates first intervention group with ASA class I and II after proper monitoring including ECG and SPO2 NIBP in D group neonates Receive Dexmedetomidine 1ml/kg after administration of the drug the patients viatal signs are recorded and repeated every 1 minute and 3 minute after administration of the drug neonates in the lateral position with a 22G needle and bolupasaine 0/2%(1MG/KG) plus epinephrine 1-2 mg experiences are under the caudal block. Intervention 2: Intervention group: neonates first intervention group with ASA class I and II after proper monitoring including ECG and SPO2 NIBP in N group infant receive normal saline 1ml/kg. after administration of the drug the patients viatal signs are recorded and repeated every 1 minute and 3 minute after administration of the drug neonates in the lateral position with a 22G needle and bolupasaine 0/2%(1MG/KG) plus epinephrine 1-2 mg experiences are under the caudal block. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Access will be 6 months after the results are printed. To whom: All Physicians and residents of the department of Anesthesia Conditions: After obtaining permission from the deputy research of group Where to obtain: Person responsible for scientific accountability of study How to obtain: First approved by the Research Vice-President Comments:
public Daryoush Sheikhzadeh
Tabriz Childrens Hospital,Sheshgelan St
Tabriz Iran (Islamic Republic of) 5136735883 +98 41 3526 2255 dr.d.sheik@gmail.com Tabriz University of Medical Sciences scientific Daryoush Sheikhzadeh
Tabriz Childrens Hospital,Sheshgelan St
Tabriz Iran (Islamic Republic of) 5136735883 +98 41 3526 2255 dr.d.sheik@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Infant Weighing less than 4 Kg Surgery of the lower abdomen ASA Class 1 and2 1 day 30 days Both Patients with congenital neurological disease and seizures Caudal injection site infection Sepsis Sensitivity to topical anesthetics Bradycardia(HR<120) Any kind of heart block Congenital cyanotic heart diseases Y48.3 Anaesthetics and therapeutic gases Treatment - Drugs Treatment - Drugs Intervention group: neonates first intervention group with ASA class I and II after proper monitoring including ECG and SPO2 NIBP in D group neonates Receive Dexmedetomidine 1ml/kg after administration of the drug the patients viatal signs are recorded and repeated every 1 minute and 3 minute after administration of the drug neonates in the lateral position with a 22G needle and bolupasaine 0/2%(1MG/KG) plus epinephrine 1-2 mg experiences are under the caudal block Intervention group: neonates first intervention group with ASA class I and II after proper monitoring including ECG and SPO2 NIBP in N group infant receive normal saline 1ml/kg. after administration of the drug the patients viatal signs are recorded and repeated every 1 minute and 3 minute after administration of the drug neonates in the lateral position with a 22G needle and bolupasaine 0/2%(1MG/KG) plus epinephrine 1-2 mg experiences are under the caudal block Blood pressure. Timepoint: After entering the operating room،After doing caudal block every 1 minute to 5 minutes and every 5 minutes till release from recovery. Method of measurement: Monitor. Heart rate. Timepoint: After entering the operating room،After doing caudal block every 1 minute to 5 minutes and every 5 minutes till release from recovery. Method of measurement: ECG device. SPO2. Timepoint: After entering the operating room،After doing caudal block every 1 minute to 5 minutes and every 5 minutes till release from recovery. Method of measurement: pulse oximeter device. Duration of the block. Timepoint: after proper monitoring in D group of neonates recieve 1ml/kg Dexmedetomidine and in N group of neonates recieve normal saline(1ml/kg) after administrating the druge the time required to perform the caudal block is recorded. Method of measurement: by an experienced anesthesiologist. The number of attempts for block. Timepoint: after proper monitoring in D group of neonates recieve 1ml/kg Dexmedetomidine and in N group of neonates recieve1ml/kg normal saline after administrating the druge the number of times you try to perform caudal block is recorded. Method of measurement: by an experienced anesthesiologist. Duration of stay in recovery. Timepoint: After entering till release from recovery. Method of measurement: According to Alderet Score. Apnea. Timepoint: After entering till release from recovery. Method of measurement: monitor and face and color scale. Sedation. Timepoint: 15 minutes after the block، and then every 5 minutes till release from recovery. Method of measurement: Sedation score table. Tabriz University of Medical Sciences Approved 2020-01-06 Ethic Committee of Tabriz University of Medical Sciences Tabriz University of Medical Science,Gholghasht,Azadi Street,Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)