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IRCT20210302050549N1 IRCT 2021-03-27 Rafsanjan University of Medical Sciences A Study of The Effect of Magnesium Sulfate on End-Tidal CO2 and Pain A Study of the Effect of Intravenous Infusion of Magnesium Sulfate on the Level of Intraoperative End-Tidal CO2 and Postoperative Pain in Laparoscopic Cholecystectomy 2021-04-04 anticipated 62 Complete https://irct.ir/trial/54697 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Participants in this study are divided into two groups of intervention (case) and control, Randomization description: This study is performed by simple randomization method using Random Number Table tool and the randomization unit is individual. Random Number Table is a set of numbers that is generated without a specific pattern or order and in a completely random form and has become a table. To use the table of random numbers, the researcher first determines the table to read the numbers from top to bottom. The second assumption of the researcher is to consider numbers for different groups, in which even numbers are considered for the case group and odd numbers for the control group. The researcher then touches one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to two groups (case and control). Random allocation concealment method in this study is SNOSE method. In this method, first a random sequence is performed, then based on the size of the research sample, a number of envelopes with aluminum wrappers are prepared and each of the random sequences created is registered on a card and the cards are placed inside the envelope. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface of the envelopes. Finally, the lids of the envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, one of the envelopes of the letter is opened and the assigned group of the participant is revealed according to the order of entry of the eligible participants. In the implementation phase of the random allocation process of this study, cases such as the individual who created the random sequence, the person who examined the participants in terms of inclusion and exit criteria, and the participants who studied and participated in the study. Assigned, it is intended that on this basis, three separate individuals perform the randomization process without being aware of the actions of other researchers, Blinding description: In this study, each participant is assigned a code that the data analyzer and the participant are unaware of which group the assigned code belongs to. 2-3 End-Tidal CO2. Intervention 1: The intervention group receives 50 mg/kg of magnesium sulfate IV in 100 cc of normal saline 0.9%. Intervention 2: The control group receives 100cc of 0.9% normal saline. 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 Its release schedule is not yet known
public Mahbube Akhundi Saleh Abad
No. 41, 6/1 Ave, Aboozar St. Rafsanjan City
Rafsanjan Iran (Islamic Republic of) 7717745767 +98 34 3428 8590 m.akhondi@rums.ac.ir Rafsanjan University of Medical Sciences scientific Mahbube Akhundi Saleh Abad
No. 41, 6/1 Ave, Aboozar St. Rafsanjan City
Rafsanjan Iran (Islamic Republic of) 7717745767 +98 34 3428 8590 m.akhondi@rums.ac.ir Rafsanjan University of Medical Sciences Iran (Islamic Republic of) ASA I-II patients 20 to 60 years of age 20 years 60 years Both Drug allergy to magnesium sulfate Drug abuse Any neuromuscular disease (Ejection Fraction)EF < 40% Hypotension or Bradycardia by more than 20% during anesthesia Cardiac disease Hepatic or Renal failure Chronic respiratory failure Morbid obesity Rehabilitation Placebo The intervention group receives 50 mg/kg of magnesium sulfate IV in 100 cc of normal saline 0.9% The control group receives 100cc of 0.9% normal saline End-Tidal CO2. Timepoint: During surgery. Method of measurement: With capnograph device. Pain severity. Timepoint: After surgery during recovery, second, sixth, 12th and 24th hours. Method of measurement: Using the VAS (Visual Analogue Scale). Blood Pressure. Timepoint: During Surgery. Method of measurement: Blood Pressure Cuff. Heart Rate. Timepoint: During Surgery. Method of measurement: ECG (electrocardiogram) Monitoring. Rafsanjan University of Medical Sciences Approved 2021-01-18 The Ethics Committee of Rafsanjan University of Medical Sciences Ali-ebn-Abitaleb Hospital, Imam Ali Blvd Rafsanjan Kerman Iran (Islamic Republic of)