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IRCT20211103052950N1 IRCT 2022-01-27 Tabriz University of Medical Sciences Comparison of Gynecologic Laparoscopic Surgeries under Spinal Anesthesia with General Anesthesia. Comparison of Gynecologic Laparoscopic Surgeries under Spinal Anesthesia with General Anesthesia. 2021-11-22 anticipated 80 Complete https://irct.ir/trial/59901 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using a table of random numbers that includes numbers from 1 to 80 with each patient up to the 80th , we randomly select a number from the number table each time (by the random selection system of the calculator and each number will have a chance to happen only once) and according to the number displayed each patient in one of the two intervention groups (40 people And the control group (40 people) are placed in such a way that if our random number is an odd number, the patient will be in the intervention group and under spinal anesthesia, and if the random number is even, the patient in the control group will undergo general anesthesia. Sample size: 80 Randomization from the researcher's point of view: random assignment to intervention and control groups Description of randomization: Randomization will be done by random blocks. In this study, in order to create a balance in the number of samples assigned to each of the study groups, the block randomization method will be used. Random allocation soft ware software will be used as a randomization tool that this software In addition to randomization, it is able to generate random sequences by blocking method. For concealment, allocation concealment will be used, which is the method used to execute random sequences on study participants so that the assigned group is not known before the individual is assigned. Assigned to study groups: Parallel, Blinding description: In this study, the anesthesiologist is completely aware of the groupings because he has to induce general anesthesia and spinal anesthesia on the patients. The same anesthesiologist and nurse collected the data during the operation and recovery, and the patient Is aware of anesthesia and only data analyzer blind to the study. N/A Comparison of laparoscopic gynecological surgeries with spinal anesthesia and general anesthesia. Intervention 1: Control group: 40 patients will be placed under general anesthesia with induction and maintenance of anesthesia with intravenous drug propofol 1% Dongkook pharmaco made in Korea and endotracheal intubation will be performed for controlled breathing during surgery and possibility of surgery according to the pain severity, hemodynamic and respiratory consequences (such as systolic blood pressure and Diastolic, mean arterial pressure, heart rate, peripheral oxygen saturation, severity of nausea and vomiting, pain intensity) will be monitored during and after surgery. Intervention 2: Intervention group: 40 patients undergoing spinal anesthesia with spinal injection of topical anesthetic bupivacaine 5% hyperbaric aspen and the patient's spontaneous respiration will be maintained and possibility of surgery according to the pain severity, hemodynamic and respiratory consequences (such as systolic and diastolic blood pressure, moderate pressure Arterial, heart rate, peripheral oxygen saturation, severity of nausea and vomiting, pain intensity) will be monitored during and after surgery. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: The data will be available to researchers working in academia and people in industry Conditions: There are no specific restrictions on the use of data or documentation Where to obtain: Dr.fateme tabatabaei Drtabatabaeigyn@gmail.com How to obtain: Applicants will have access to the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Doctor fateme tabatabaei
South Army Street - Al-Zahra Hospital - Operating Room of Tabriz, East Azerbaijan Province
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 3476 7121 Drtabatabaeigyn@gmail.com Tabriz University of Medical Sciences scientific Doctor fateme tabatabaei
South Army Street - Al-Zahra Hospital - Operating Room of Tabriz, East Azerbaijan Province
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 3476 7121 Drtabatabaeigyn@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Female with ASA class I _ II physical condition Candidate for gynecological laparoscopic surgery in the age range of 18-60 years in Alzahra Hospital, Tabriz Laparoscopic uterine adnexal surgeries include cystectomy, salpingectomy, oophorectomy, and ectopic pregnancy, all of which are almost identical in terms of surgery time and difficulty. Patient consent to study 18 years 60 years Female Hemoglobin less than 10 Unusual bleeding during surgery and the need for transfusions of blood and blood products Need to convert surgery to laparotomy Existence of any contraindications to spinal anesthesia Sensitivity to local spinal anesthetics Obesity history of multiple surgeries more than twice, history of previous myomectomy,History of previous intra-abdominal adhesions Accompanying systemic diseases such as any history of cardiovascular, pulmonary, hepatic, renal, etc. Grade three and four gynecological surgeries include hysterectomy, resection of tubo-ovarian abscesses, advanced endometriosis, myomectomy, abdominal cerclage, resection of the lateral horn of the uterus, and any disease with intra-abdominal adhesions. T88.59 Other complications of anesthesia Prevention Prevention Control group: 40 patients will be placed under general anesthesia with induction and maintenance of anesthesia with intravenous drug propofol 1% Dongkook pharmaco made in Korea and endotracheal intubation will be performed for controlled breathing during surgery and possibility of surgery according to the pain severity, hemodynamic and respiratory consequences (such as systolic blood pressure and Diastolic, mean arterial pressure, heart rate, peripheral oxygen saturation, severity of nausea and vomiting, pain intensity) will be monitored during and after surgery. Intervention group: 40 patients undergoing spinal anesthesia with spinal injection of topical anesthetic bupivacaine 5% hyperbaric aspen and the patient's spontaneous respiration will be maintained and possibility of surgery according to the pain severity, hemodynamic and respiratory consequences (such as systolic and diastolic blood pressure, moderate pressure Arterial, heart rate, peripheral oxygen saturation, severity of nausea and vomiting, pain intensity) will be monitored during and after surgery. Ability to perform surgery according to the severity of pain during surgery. Timepoint: Operation time. Method of measurement: Visual analog scoring (all the time during operation, whenever the pain is more than 4 based on the analog visual score, a sedative and analgesic drug is prescribed and general anesthesia is induced if the surgery is not tolerated.). Severe postoperative nausea and vomiting. Timepoint: Every 5 minutes in recovery until discharge from recovery and transfer to ward). Method of measurement: How to measure the variable based on scoring (0 = no nausea and vomiting, 1 = nausea, 2 = vomiting and 3 = vomiting more than 2 times. Severe postoperative pain. Timepoint: Recovery at 3, 6, 12, 18 and 24 hours after surgery. Method of measurement: verbal rating scale four numbers. Peripheral O2 saturation. Timepoint: Measurement intervals from the beginning of anesthesia every 5 minutes and in recovery until discharge every 10 minutes. Method of measurement: Pulse oximeter device. Heart beat. Timepoint: Measurement intervals from the beginning of anesthesia every 5 minutes and in recovery until discharge every 10 minutes. Method of measurement: Counting the heart beats per minutes. Mean arterial pressure. Timepoint: Measurement intervals from the beginning of anesthesia every 5 minutes and in recovery until discharge every 10 minutes. Method of measurement: Mercury barometer. Tabriz University of Medical Sciences Approved 2021-10-25 Ethics Committee of Tabriz University of Medical Sciences Golgasht St., Deputy of Research and Technology City Tabriz East Azarbaijan Iran (Islamic Republic of)