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IRCT20171228038117N2 IRCT 2018-02-11 Semnan University of Medical Sciences Comparing Spinal and General Anesthesia in terms of Postoperative Pain inPatients Undergoing Hysterectomy Comparing Spinal and General Anesthesia in terms of Postoperative Pain inPatients Undergoing Hysterectomy 2016-11-21 anticipated 50 Complete https://irct.ir/trial/28634 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization, Blinding description: Participants were unaware of the type of anesthesia. 3 Post Hysterectomy pain. Intervention 1: Intervention group: After anesthetic monitoring including pulse oximetry, ECG and blood pressure monitoring, premedication was administered by injecting benzodiazepine (intravenous midazolam, 2 mg) and a synthetic narcotic (intravenous fentanyl, 1 mg/kg body weight). GA was induced by injecting intravenous thiopental sodium 5 mg/kg bw, and the muscle relaxant, Atracurium, 0.5 mg/kg bw. After endotracheal intubation, inhalation anesthetic(including equal proportions of oxygen and Nitrous oxide, 4 L/min) and evaporation anesthetic (halogenated anesthetic: Isoflurane 1.2%, 1 MAC) were administered to maintainanesthesia and patients underwent mechanical ventilation using anesthesia ventilators.The patient was extubated at the end of the operation after discontinuing anesthetics and reversing the effects of the muscle relaxants using anticholineste rasessuch asneostigmine 40-70 µg/kg bw and anticholinergicssuch asintramuscular atropine 15µg/kg b w. They were then transferred to PACU (recovery room). Intervention 2: Control group: After anesthetic monitoring of the patient, including pulse oximetry, ECG and blood pressure monitoring, minimal 500 cc crytalloids serum was intravenously administered to prevent hypotension secondary to SA. After placing the patient in a seated position and using povidone-iodine solution for sterilizing the site of lumbar puncture, the L4/L5intervertebral space was identified. A cutting-tipped 25-gauge (orange) spinal needle was inserted into the intrathecal area, and the accuracy of the technique was ensured by the appearance of cerebrospinal fluid. A total of 3 cc hyperbaric bupivacaine solution 0.5%was then injected into the subarachnoid space and the patient was placed in supine position. After stabilizing SA, the position was adjusted so as to allow the local anesthetic to move toward the T8 area. A needle or alcohol-soaked cotton was used to identify the anesthetic area and the operation began after this area was stabilized. In case of agitation during operation, 1-2 mg of intravenous midazolam was administered, and the patient was transferred to PACU after the operation. 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 Needs to review
public Babak Hoseinzadeh zorofchi
Department of Anesthesiology,Kosar Hospital,Semnan University of Medical Sciences,Semnan
Semnan Iran (Islamic Republic of) 3517816615 +98 23 3343 7838 babak.hoseinzadeh@semums.ac.ir Semnan University of Medical Sciences scientific Babak Hoseinzadeh zorofchi
Department of Anesthesiology, Kosar Hospital,Semnan University of Medical Sciences, Semnan
Semnan Iran (Islamic Republic of) 3517816615 +98 23 3343 7838 babak.hoseinzadeh@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) American Society of Anesthesiologists (ASA) I and II class Candidate for hysterectomy 20 years 70 years Female Prefer a specific method of anesthesia Psychiatric diseases under medical treatment Patients with chronic or acute pain An anatomical disorder that requires a specific anesthetic method Treatment - Drugs Treatment - Drugs Intervention group: After anesthetic monitoring including pulse oximetry, ECG and blood pressure monitoring, premedication was administered by injecting benzodiazepine (intravenous midazolam, 2 mg) and a synthetic narcotic (intravenous fentanyl, 1 mg/kg body weight). GA was induced by injecting intravenous thiopental sodium 5 mg/kg bw, and the muscle relaxant, Atracurium, 0.5 mg/kg bw. After endotracheal intubation, inhalation anesthetic(including equal proportions of oxygen and Nitrous oxide, 4 L/min) and evaporation anesthetic (halogenated anesthetic: Isoflurane 1.2%, 1 MAC) were administered to maintainanesthesia and patients underwent mechanical ventilation using anesthesia ventilators.The patient was extubated at the end of the operation after discontinuing anesthetics and reversing the effects of the muscle relaxants using anticholineste rasessuch asneostigmine 40-70 µg/kg bw and anticholinergicssuch asintramuscular atropine 15µg/kg b w. They were then transferred to PACU (recovery room). Control group: After anesthetic monitoring of the patient, including pulse oximetry, ECG and blood pressure monitoring, minimal 500 cc crytalloids serum was intravenously administered to prevent hypotension secondary to SA. After placing the patient in a seated position and using povidone-iodine solution for sterilizing the site of lumbar puncture, the L4/L5intervertebral space was identified. A cutting-tipped 25-gauge (orange) spinal needle was inserted into the intrathecal area, and the accuracy of the technique was ensured by the appearance of cerebrospinal fluid. A total of 3 cc hyperbaric bupivacaine solution 0.5%was then injected into the subarachnoid space and the patient was placed in supine position. After stabilizing SA, the position was adjusted so as to allow the local anesthetic to move toward the T8 area. A needle or alcohol-soaked cotton was used to identify the anesthetic area and the operation began after this area was stabilized. In case of agitation during operation, 1-2 mg of intravenous midazolam was administered, and the patient was transferred to PACU after the operation. Post operative pain. Timepoint: After 30 min. Method of measurement: visual analogue scale (VAS). Nausea. Timepoint: 0, 6 and 12 h after the operation. Method of measurement: Visual Analogue Scale (VAS). Vometing. Timepoint: 0, 6 and 12 h after the operation. Method of measurement: Visual Analogue Scale (VAS). Semnan University of Medical Sciences Approved 2015-11-23 Ethics committee of Semnan University of Medical Sciences Basij Ave, Semnan Town Semnan Semnan Iran (Islamic Republic of)