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IRCT20180411039267N4 IRCT 2021-02-15 Tabriz University of Medical Sciences Comparison of hemodynamic and respiratory changes in anesthesia and laparoscopic gynecological surgeries Comparing the changes in hemodynamic and respiratory parameters in two methods of spinal anesthesia versus general anesthesia in diagnostic gynecologic laparoscopy 2021-01-29 anticipated 74 Complete https://irct.ir/trial/54150 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: Using a table of random numbers that includes numbers from 1 to 74 and with each referral up to 74th patient,each time we randomly select a number from the number table(by calculators random numbers system and each number will have a chance to happen only once) and depending on what number comes up,each patient is placed in one of the two intervention groups (37 people) and the control group (37 people).Thus,if our random number was odd, the patient will be in the intervention group and will undergo spinal anesthesia and if our random number was even,the patient will undergo general anesthesia in the control group, Blinding description: In this study, the anesthesiologist is fully aware of the groupings because he has to induce general anesthesia and anesthesia on patients. The same anesthesiologist and nurse collected the data during the operation and recovery, and the patient are Conscious of anesthesia or numbness, and only the data analyzer is blind to the study. N/A Comparison of hemodynamic and respiratory changes in spinal anesthesia and general anesthesia in diagnostic laparoscopy in women. Intervention 1: Control group:37 patients will be placed under general anesthesia with induction and maintenance of anesthesia with 1% intravenous propofol drug of Dongkook pharmaco company made in Korea and endotracheal intubation will be performed for controlled breathing during surgery and hemodynamic and respiratory consequences (such as Systolic and diastolic blood pressure, mean arterial pressure, heart rate, saturation of peripheral oxygen, severity of nausea and vomiting, severity of pain )during and after surgery will be assessed. Intervention 2: Intervention group:37 patients undergoing spinal anesthesia with spinal injection of topical anesthetic bupivacaine 5% hyperbaric manufactured by aspen company and spontaneous respiration will be maintained and hemodynamic and respiratory consequences (such as systolic and diastolic blood pressure, mean arterial pressure, heart rate, saturation of peripheral oxygen, severity of nausea and vomiting, severity of pain)during and after surgery will be assessed. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making peoples unrecognizable. When: Starting 6 months after publication To whom: Documents will be available for people working in academic institutions and also people working in businesses Conditions: There will be no specific limitations to the utilization of the data Where to obtain: Dr .Reyhaneh Abri, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , re.abri@tbzmed.ac.ir How to obtain: Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Reyhaneh Abri
Operating room-alzahra hospital- south artesh st
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 3476 7121 reyhane.abri@gmail.com Tabriz University of Medical Sciences scientific Reyhaneh Abri
Operating room-alzahra hospital- south artesh st
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 3476 7121 reyhane.abri@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Female with physical condition ASA(American Society of Anesthesiologists) class I or II In the age range of 60-18 years candidate for laparoscopic gynecological surgery Patient consent to study 18 years 60 years Female Existence of any contraindications to regional anesthesia Sensitivity to local anesthetics Excessive obesity Accompanying systemic diseases such as any history of cardiovascular, pulmonary, hepatic, renal, etc. T88.59 Other complications of anesthesia Prevention Prevention Control group:37 patients will be placed under general anesthesia with induction and maintenance of anesthesia with 1% intravenous propofol drug of Dongkook pharmaco company made in Korea and endotracheal intubation will be performed for controlled breathing during surgery and hemodynamic and respiratory consequences (such as Systolic and diastolic blood pressure, mean arterial pressure, heart rate, saturation of peripheral oxygen, severity of nausea and vomiting, severity of pain )during and after surgery will be assessed. Intervention group:37 patients undergoing spinal anesthesia with spinal injection of topical anesthetic bupivacaine 5% hyperbaric manufactured by aspen company and spontaneous respiration will be maintained and hemodynamic and respiratory consequences (such as systolic and diastolic blood pressure, mean arterial pressure, heart rate, saturation of peripheral oxygen, severity of nausea and vomiting, severity of pain)during and after surgery will be assessed. Systolic and diastolic blood pressure. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Mercury barometer. Mean arterial pressure(MAP). Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Mercury barometer. Heart rate. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Counting in each minutes. Saturation of peripheral oxygen. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Via the Pulse Oximeter. Severity of postoperative nausea and vomiting. Timepoint: Every 5 minutes in recovery until discharge from recovery and transfer to ward. Method of measurement: scoring by (0=non, 1=nausea, 2=vomiting, 3=vomiting >2 times). Severity of postoperative pain. Timepoint: Recovery and at 3, 6, 12,18 and 24 hours postoperatively. Method of measurement: Four Numerical Verbal Rating Scale. Tabriz University of Medical Sciences Approved 2021-01-25 Ethic Committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)