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IRCT20200605047662N1 IRCT 2020-06-09 Esfahan University of Medical Sciences Effect of Nasal fentanyl in patients with cataract surgery Comparison of the Effectiveness of Nasal fentanyl vs. Intravenous (IV) fentanyl in anesthesia in patients with cataract surgery 2017-03-19 anticipated 90 Complete https://irct.ir/trial/48676 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The 45 pieces of paper that were written on it A and the other 45 pieces that were written B (a total of 90 pieces) are folded into a non-transparent bag. Then 30 minute before the operation, one of the pieces were selected randomly by a person who does not know about the details. In case of A patient categorized as the intera-venous fentanyl group, and in case of B, it belongs to the nasal fentanyl group, Blinding description: In 30 minute before the surgery, the patient was selected to A and B group by using pieces of paper in a non-transparent bag by person who did not know about the details. The patient didnt know about the grouping. The patient was taken to the operating room and the surgeon and staff of the relevant room did not know about the grouping. After the surgery, the surgeon's satisfaction was recorded by the person who did not know about the grouping. The patient transferred to the recovery room, where was evaluated by the person who had no information about the grouping and the patient's information was recorded. In the operating room, only the person who performed the lottery knew about the grouping, and this person had intravenous and nasal fentanyl in addition to distilled water in the form of nasal and intravenous form, and he was the only person who knew which fentanyl and which distilled water were also. This person was not present in any other part of the patient's information collection and evaluation. N/A Cataract. Intervention 1: Intervention group 1: Patients after grouping, if they were in the nasal fentanyl group, were given a single dose of intranasal fentanyl (1 mg / kg with a volume of 2 cc),10 minutes before the surgery and at the beginning of surgery, Distilled water (2 cc) were prescribed Intravenously. Intervention 2: Intervention group 2: Patients after grouping, if they were in the intera-venous fentanyl group, were given a single dose of intranasal Distilled water (2 cc) ,10 minutes before the surgery and at the beginning of surgery, fentanyl (1 mg / kg with a volume of 2 cc) were prescribed Intravenously. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Hamed Norouzi
Hezar-Jarib street., University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7654 Hamednorouzi7337@gmail.com Esfahan University of Medical Sciences scientific Hamed Norozi
Hezar-Jarib., University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7654 Hamednorouzi7337@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) More than 18 years old American Society of Anesthesiologists Classification (ASA) 1 or 2 Candidate for cataract surgery by Phacoemulsification method 18 years no limit Both History of any allergic reaction to any of the treatment regimensHistory of head injury, high intraocular or intracranial pressure, high-risk for cardiovascular disease, severe respiratory disease, liver disease, advanced epilepsy or seizure history, neurological disorder, tumor or brain metastasis Use of any anesthetics in last day Chronic pain syndromes H25 Age-related cataract Treatment - Drugs Treatment - Drugs Intervention group 1: Patients after grouping, if they were in the nasal fentanyl group, were given a single dose of intranasal fentanyl (1 mg / kg with a volume of 2 cc),10 minutes before the surgery and at the beginning of surgery, Distilled water (2 cc) were prescribed Intravenously Intervention group 2: Patients after grouping, if they were in the intera-venous fentanyl group, were given a single dose of intranasal Distilled water (2 cc) ,10 minutes before the surgery and at the beginning of surgery, fentanyl (1 mg / kg with a volume of 2 cc) were prescribed Intravenously Relaxation level during surgery. Timepoint: After surgery, In Recovery room. Method of measurement: Ramsay Sedation Scale questionnaire. Satisfaction of the surgeon. Timepoint: After surgery. Method of measurement: Visual Analogue Scale questionnaire. Satisfaction of the patient. Timepoint: After surgery. Method of measurement: Visual Analogue Scale questionnaire. Esfahan University of Medical Sciences Approved 2019-06-09 Ethics committee of Isfahan University of Medical Sciences Isfahan University of medical sciences., Azadegan street., Hezar-Jarib blvd., Isfahan Isfahan Isfehan Iran (Islamic Republic of)