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IRCT20211017052786N4 IRCT 2022-07-11 Ghoum University of Medical Sciences Comparison of the effect of different doses of intrathecal Ropivacaine in surgery Comparing the Effect of Four Different Doses of Intrathecal Isobaric Ropivacaine on Patients Undergoing Elective Infra-umbilical Surgeries 2022-06-22 anticipated 140 Complete https://irct.ir/trial/64308 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 140 patients undergoing umbilical cord surgery will be randomly divided into four groups of 35 patients. Random assignment of patients to four groups is based on block method. Each block will be selected at random. Block Randomization is done using dice. Throwing the dice will be done enough to complete the assignment of patients to treatment groups. The size of the block is 8 and we will have different and random combinations of AABBCCDD. The selection of each block will be random to complete the allocation of patients to treatment groups with four different doses. Assignment of treatment to groups A, B, C and D will also be based on accident, Blinding description: This study is a double-blind randomized clinical trial (RCT) in which the participating patients, specialist assistant and surgeon do not know the type of dose assignment to the group. 2 Spinal anesthesia using ropivacaine. Intervention 1: Intervention group 1: Candidate patients for below-umbilical surgery for spinal anesthesia receive 4 ml of 0.5% Ropivacaine with chemical formula (C17H26N2O) equivalent to 20 mg intra-cerebrospinal fluid (CSF). Intervention 2: Intervention group 2: Candidate patients for below-umbilical surgery for spinal anesthesia receive 4.5 ml of Ropivacaine 0.5% with chemical formula (C17H26N2O) equivalent to 22.5 mg intra-cerebrospinal fluid (CSF). Intervention 3: Intervention group 3: Candidate patients for below-umbilical surgery for spinal anesthesia receive 5 ml of 0.5% Ropivacaine with chemical formula (C17H26N2O) equivalent to 25 mg intra-cerebrospinal fluid (CSF). Intervention 4: Intervention group 4: Candidate patients for below-umbilical surgery for spinal anesthesia receive 5.5 ml of Ropivacaine 0.5% with chemical formula (C17H26N2O) equivalent to 27.5 mg intra-cerebrospinal fluid (CSF). No - There is not a plan to make this available Justification or reason for not sharing IPD is The data are specific to the present study
public Amir Hossein Moradi Rafigh
No. 46, 32th Ave., Keshavarz Shomali Blvd.
Qom Iran (Islamic Republic of) 3715178817 +98 25 3885 6440 Amirmmr287@gamil.com Ghoum University of Medical Sciences scientific Fatemeh Gghannadi
No. 46, 32th Ave., Keshavarz Shomali Blvd.
Qom Iran (Islamic Republic of) 3715178817 +98 25 3885 6440 Amirmmr287@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Iranian race Patients with American Stroke Association (ASA) grade 1, 2 Umbilical cord surgeries Age over 18 and under 65 years 18 years 65 years Both Allergy to amide drugs Pregnancy History of substance abuse Heart rate less than 60 beats per minute at rest T88.5 Other complications of anesthesia Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Candidate patients for below-umbilical surgery for spinal anesthesia receive 4 ml of 0.5% Ropivacaine with chemical formula (C17H26N2O) equivalent to 20 mg intra-cerebrospinal fluid (CSF). Intervention group 2: Candidate patients for below-umbilical surgery for spinal anesthesia receive 4.5 ml of Ropivacaine 0.5% with chemical formula (C17H26N2O) equivalent to 22.5 mg intra-cerebrospinal fluid (CSF). Intervention group 3: Candidate patients for below-umbilical surgery for spinal anesthesia receive 5 ml of 0.5% Ropivacaine with chemical formula (C17H26N2O) equivalent to 25 mg intra-cerebrospinal fluid (CSF). Intervention group 4: Candidate patients for below-umbilical surgery for spinal anesthesia receive 5.5 ml of Ropivacaine 0.5% with chemical formula (C17H26N2O) equivalent to 27.5 mg intra-cerebrospinal fluid (CSF).. Levels of sensory and motor block. Timepoint: In minutes 15,10,8,8,6,4,2. Method of measurement: Motor nerves using voice commands for the patient and Pinprick of skin to observe the sensory nerve response. Ghoum University of Medical Sciences Approved 2022-06-19 Ethics Committee of QOM University of Medical Sciences No.10, 13th Ave., Emam Street. Qom Ghoum Iran (Islamic Republic of)