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IRCT20210714051888N1 IRCT 2021-12-19 Iran University of Medical Sciences Succinylcholine and Rocuronium effects on the rate of emergence agitation A comparison of Succinylcholine and Rocuronium effects on the rate of emergence agitation when awakening in patients undergoing direct diagnostic laryngoscopy under general anesthesia 2021-11-22 anticipated 48 Complete https://irct.ir/trial/58191 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization in this clinical trial will be performed by blocking method. Accordingly, 8 blocks will be used, with 6 patients in each block (3 patients in the Saxinylcholine group and 3 patients in the Rocronium group). Randomization is done using random allocation softwares. In addition to simple randomization, these softwares are able to generate random sequences by blocking method. Random allocation concealment is used for hiding Which refers to the method used to execute a random sequence on the participants in the study, so that the assigned group is not known before the individual is assigned. Sequentially numbered opaque envelopes are also used, in which each of the random sequences created is recorded on a card and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelope lids are glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: Patient information will be recorded in the data collection sheets by examination by a physician. The patient, the injector, and the person recording the results will be unaware of the type of drug. The person preparing the medicine will be different from the person who injected it. 2 Diagnostic biopsy under direct laryngoscopy. Intervention 1: Intervention group 1: succinylcholine.The first group will receive 3 micrograms / kg of fentanyl and 0.5 mg / kg of lidocaine for premedication, and will be induced with 1 mg / kg of succinylcholine and 5 mg / kg of Nesdonal.The medications used will be common medications available in the operating room. Intervention 2: Intervention group 2: Rocronium. The second group will receive 3 micrograms / kg of fentanyl and 0.5 mg / kg of lidocaine for premedication and will be induced with 0.6 mg / kg rocuronium and 5 mg / kg Nesdonal. Second, patients will receive rocuronium instead of succinylcholine.The medications used will be common medications available in the operating room. Yes - There is a plan to make this available What will be shared: All data can be shared after people are not identified. When: The data will be available 6 months after the results are published. To whom: Researchers from scientific and academic institutions can apply for the data. Conditions: The data can only be used for scientific research by researchers in scientific and academic centers. Where to obtain: Researchers can send their request via email to the project manager. How to obtain: Applications must be accompanied by a letter of introduction from the institution or university where the researcher is employed. The data will be provided to the researcher no later than two weeks after receiving the request. Comments:
public Dr Saeid Amniati
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 1000 amniati.s@iums.ac.ir Iran University of Medical Sciences scientific Saeid Amniati
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 1000 amniati.s@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients 20 to 50 years without a history of disease or with a controlled disease 20 years 50 years Both The patients with a history of psychiatric illness The patients with a history of peritonitis The patients with a history of hyperkalemia The patients with a history of renal and hepatic failure The patients with a history of malignant hyperthermia and pseudocholinesterase deficiency The patients with a history of addiction The patients with a history of benzodiazepines The patients with a history of burns Treatment - Drugs Treatment - Drugs Intervention group 1: succinylcholine.The first group will receive 3 micrograms / kg of fentanyl and 0.5 mg / kg of lidocaine for premedication, and will be induced with 1 mg / kg of succinylcholine and 5 mg / kg of Nesdonal.The medications used will be common medications available in the operating room Intervention group 2: Rocronium. The second group will receive 3 micrograms / kg of fentanyl and 0.5 mg / kg of lidocaine for premedication and will be induced with 0.6 mg / kg rocuronium and 5 mg / kg Nesdonal. Second, patients will receive rocuronium instead of succinylcholine.The medications used will be common medications available in the operating room Agitation. Timepoint: From the moment of closing the gas until 10 minutes after estubation for once. Method of measurement: Emergency agitation of patients from the moment of gas closure until 10 minutes after extubation will be performed according to the criteria of Ricker Sedation Agitation Scale. Myalgia. Timepoint: Myalgia pain scores will be recorded 1, 4, 8 and 24 hours after surgery. Method of measurement: Examination by a Physician. دانشگاه علوم پزشکی ایران Approved 2020-11-30 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Tehran Tehran Tehran Iran (Islamic Republic of)