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IRCT20230122057174N1 IRCT 2023-02-01 Shiraz University of Medical Sciences Comparison of the effects of lidocaine and bupivacaine in preventing oculocardiac reflex in strabismus surgery Comparison of the effectiveness of lidocaine and bupivacaine Sub-tenon injection in preventing oculocardiac reflex in strabismus surgery 2023-03-01 anticipated 120 Complete https://irct.ir/trial/68133 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 6 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 20 blocks of size 6 will be selected randomly and patients will be allocated randomly and equally into three groups according to these permutation block. block sequence will be prepare by www.Randomization.com, Blinding description: Identical syringes containing 4 ml of bupivacaine 0.5% or 4 ml of lidocaine 0.5% are provided by the first person, these drugs, which have the same color and size and in similar colors, are injected by the second person who is completely unaware of the contents of the syringes. The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind. 2 Strabismus. Intervention 1: Intervention group A: After induction of anesthesia, 4cc of bupivacaine (brand name Marcaine) will be injected into the subtenon space of the operated eye. Intervention 2: Intervention group B: After induction of anesthesia, 4 cc of lidocaine will be injected into the subtenon space of the operated eye. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy
public Mohsen Dehghanpoor farashah
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 arefaneh_2002@yahoo.com Shiraz University of Medical Sciences scientific Mehrdad Salari
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 msalari@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) ASA grade I or II (American Society of Anesthesiology classification) Patients between 18 and 35 years old Candidate patients for Sub-Tenon's block 18 years 60 years Both Patients with ASA grade III or IV (American Society of Anesthesiology classification) Positive history of heart disease Positive history of hyperthyroidism Positive history of coagulation disorders Pregnant women Patient refusal H50.9 Unspecified strabismus Treatment - Drugs Treatment - Drugs Intervention group A: After induction of anesthesia, 4cc of bupivacaine (brand name Marcaine) will be injected into the subtenon space of the operated eye. Intervention group B: After induction of anesthesia, 4 cc of lidocaine will be injected into the subtenon space of the operated eye. Heart rate. Timepoint: Every 5 minutes during the operation. Method of measurement: Monitoring. Mean arterial pressure. Timepoint: Every 5 minutes during the operation. Method of measurement: Monitoring. Pain. Timepoint: One hour after the operation. Method of measurement: Questionnaire and Numerical Pain Rating Scale (NRS). Nausea. Timepoint: One hour after the operation. Method of measurement: History taking. Vomiting. Timepoint: One hour after the operation. Method of measurement: History taking. Shiraz University of Medical Sciences Approved 2022-12-18 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)