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IRCT20120814010599N30 IRCT 2021-09-20 Iran University of Medical Sciences Comparison of intraoperative opioid use in two opioid injections by Analgesia nociception index (ANI) and conventional method Comparison of intraoperative opioid use in two opioid injections according to the pain score determined by the Analgesia nociception index (ANI) and conventional injections in laparoscopic gynecological surgery 2021-08-20 anticipated 90 Complete https://irct.ir/trial/48465 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were randomly divided into two groups of analgesia with Analgesia nociception index(ANI) and conventional method using random allocation software. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers, Blinding description: The patient and the statistical analyzer were unaware of the analgesia methods the patient is using. Analgesia was performed by an anesthesiologist in the operating room for randomly selected patients. In this way, the patient was only aware of the analgesia being performed on him/her but was unaware of its type and also the statistical analyzer will receive the data in code A and B for the intervention groups. 2-3 Pain. Intervention 1: Intervention group: In the Analgesia nociception index (ANI) intervention group, control for analgesia of patients during the operation of remifentanil (Produced by Exir) will be performed according to the pain score determined by the Analgesia nociception index (ANI) device. In the ANl group, two electrodes will be placed on the sternum and the left mid axillary line. Total remifentanil consumption was recorded as micrograms. Intraoperative pain measurement will be performed with the same device that measures pain score under anesthesia. It should be noted that pain score is scored by analyzing by the device. The device will be continuously connected to the patient and in case of changes beyond the desired range, the patient will be injected with medication. Intervention 2: Control group: In this group conventional method will be done (drug injection if the patient expresses pain). 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 There is no further information.
public Poupak Rahimzadeh
Fifth floor, Central headquarters, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1433933111 +98 21 6650 9059 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences scientific Poupak Rahimzadeh
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1433933111 +98 21 6650 9059 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Candidate of laparoscopic gynecological surgery Age between 18-45 years Body mass index (BMI) less than 25 18 years 45 years Female Having cardiac arrhythmia Patients with central or autonomic neurological problems undergoing opioid treatment G89 Pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: In the Analgesia nociception index (ANI) intervention group, control for analgesia of patients during the operation of remifentanil (Produced by Exir) will be performed according to the pain score determined by the Analgesia nociception index (ANI) device. In the ANl group, two electrodes will be placed on the sternum and the left mid axillary line. Total remifentanil consumption was recorded as micrograms. Intraoperative pain measurement will be performed with the same device that measures pain score under anesthesia. It should be noted that pain score is scored by analyzing by the device. The device will be continuously connected to the patient and in case of changes beyond the desired range, the patient will be injected with medication. Control group: In this group conventional method will be done (drug injection if the patient expresses pain) Total dose of opioid used during surgery. Timepoint: After surgery. Method of measurement: Patient file. Pain. Timepoint: At 1, 12 and 24 hours after surgery. Method of measurement: Visual analog scale. Iran University of Medical Sciences Approved 2021-05-17 Ethics committee of Iran University of Medical Sciences. Vice chancellor for research, Iran University of Medical Sciences, beside Milad Tower, Hemat highway Tehran Tehran Iran (Islamic Republic of)