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IRCT20220519054914N1 IRCT 2022-07-01 Tabriz University of Medical Sciences Comparative study of Rocuronium deep muscular blockage in laparoscopic cholecystectomy Comparative study of Rocuronium deep muscular blockage in Isofluorane and Total Intravenous Anesthesia (TIVA) on peritoneal compliance and surgical conditions during laparoscopic cholecystectomy 2022-09-23 anticipated 80 Complete https://irct.ir/trial/63822 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: After the initial diagnosis, patients are divided into groups of one or two based on a sealed envelope to be nominated for surgery. Group one will receive the inhalation method and the second group will receive the complete intravenous method. It should be noted that it is typed in approximately 40 envelopes of group one and in the next 40 envelopes of the second group, and each patient chooses an envelope without knowing the contents of the envelope, Blinding description: The patient, the surgeon, and the person who is collecting the data are blinded to the type of anesthesia and the details. 3 Deep muscular blockage with Rocoronium and abdominal compliance. Intervention 1: The first intervention group: Deep muscular blockage (TOF=0 or PTC=0-4) with Rocuronium accompanied by inhalation anesthesia. Intervention 2: The second intervention group: Deep muscular blockage (TOF=0 or PTC=0-4) with Rocuronium accompanied by total intravenous anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Hamzeh Hosseinzadeh
Imam Reza Hospital, Golgasht Street
Tabriz Iran (Islamic Republic of) 5167754836 +98 41 3334 7054 hamzeh1338@yahoo.com Tabriz University of Medical Sciences scientific Hamzeh Hosseinzadeh
Imam Reza Hospital, Golgasht Street
Tabriz Iran (Islamic Republic of) 5167754836 +98 41 3334 7054 hamzeh1338@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients undergoing laparoscopic cholecystectomy Conscious consent for study No allergic reaction to all drugs used BMI (Body Mass Index) <35 Lack of hypertension, respiratory disease, history of aspiration, liver and kidney diseases, neuromuscular diseases, dwarf and patients with active infection 18 years 65 years Both Dissatisfaction BMI>35 Patients whose operation is finally opened Allergic reaction to all drugs used Hypertension, respiratory disease, history of aspiration, liver and kidney diseases, neuromuscular diseases, dwarf and patients with active infection Treatment - Surgery Treatment - Surgery The first intervention group: Deep muscular blockage (TOF=0 or PTC=0-4) with Rocuronium accompanied by inhalation anesthesia The second intervention group: Deep muscular blockage (TOF=0 or PTC=0-4) with Rocuronium accompanied by total intravenous anesthesia The effect of deep muscular blockage on intra-abdominal pressure in laparoscopic cholecystectomy after inhaled anesthesia in laparascopic cholecystectomy. Timepoint: Muscular blockage is monitored to maintain TOF = 1-3, PTC = 4-8. To maintain the blockage, Rocuronium infusion is started at a rate of 20 mg per hour and titrated for the desired relaxation. Intra-abdominal pressure is measured at this rate of relaxation. In groups with deep relaxation, the rate of Rocronium infusion will be increased and titrated to achieve TOF = 0 and PTC = 0-4. Changes in abdominal pressure are measured in both anesthesic methods. Method of measurement: Intra-abdominal pressure will be measured with laparoscope and the abdominal compliance by measuring the length of the xiphoid to the pubis. The effect of deep muscular blockage with Recuronium on intra-abdominal pressure in laparoscopic cholecystectomy with total intravenous anesthesia. Timepoint: Before and after deep muscular blockage. Method of measurement: The TOF and POC values will be measured before and after deep muscular blockage. The effect of deep muscular blockage with Recuronium on the quality of operating conditions in laparoscopic cholecystectomy anesthesized with isoflurane. Timepoint: Before and after deep muscular blockage. Method of measurement: 1: Extremely poor conditions: the surgeon is unable to work because of coughing or because of the inability to obtain a visible laparoscopic field because of inadequate muscle relaxation. Additional neuromuscular blocking agents must be given.2: Poor conditions: there is a visible laparoscopic field, but the surgeon is severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional neuromuscular blocking agents must be given.3: Acceptable conditions: there is a wide visible laparoscopic field, but muscle contractions, movements, or both occur regularly, causing some interference with the surgeon’s work. There is a need for additional neuromuscular blocking agents to prevent deterioration.4: Good conditions: there is a wide laparoscopic working field with sporadic muscle contractions, movements, or both. There is no immediate need for additional neuromuscular blocking agents unless there is a fear of deterioration.5: Optimal conditions: there is a wide visible laparoscopic working field without any movement or contractions. The effect of deep muscular blockage with Rocronium on the quality of operating conditions in laparoscopic cholecystectomy with total intra venous anesthesia. Timepoint: Before and after deep muscular blockage. Method of measurement: 1: Extremely poor conditions: the surgeon is unable to work because of coughing or because of the inability to obtain a visible laparoscopic field because of inadequate muscle relaxation. Additional neuromuscular blocking agents must be given.2: Poor conditions: there is a visible laparoscopic field, but the surgeon is severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional neuromuscular blocking agents must be given.3: Acceptable conditions: there is a wide visible laparoscopic field, but muscle contractions, movements, or both occur regularly, causing some interference with the surgeon’s work. There is a need for additional neuromuscular blocking agents to prevent deterioration.4: Good conditions: there is a wide laparoscopic working field with sporadic muscle contractions, movements, or both. There is no immediate need for additional neuromuscular blocking agents unless there is a fear of deterioration.5: Optimal conditions: there is a wide visible laparoscopic working field without any movement or contractions. Tabriz University of Medical Sciences Approved 2022-04-22 Ethics committee of Tabriz University of Medical Sciences No. 21, Nastaran 4, Babaei 1 Ave., Parvaz Alley, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)