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IRCT20120915010841N26 IRCT 2021-11-07 Hamedan University of Medical Sciences Comparison of three anesthesia methods in hysteroscopic surgery Comparative evaluation of effect of General anesthesia, Spinal anesthesia and Paracervical block on pain, nausea, vomiting and analgesic requirements in diagnostic Hysteroscopy. 2021-12-05 anticipated 66 Complete https://irct.ir/trial/58913 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Hysteroscopic surgery under general anesthesia, spinal anesthesia or para cervical block. Intervention 1: Intervention group1: In all patients after entering the operating room, using a 18 intravenous lines, after receiving 5 ml/kg of serum Ringer, in general anesthesia group, 0.02mg/kg midazolam, 1ug ​/kg Fentanyl and 2mg/kg of propofol are injected intravenously and then the suitable LMA is placed (proportional to the patient's weight) and is used to maintain anesthesia from 1.2% isoflurane and 50%N2o.The patient is then subjected to hysteroscopy with a rigid hysteroscope (Storz Hysteroscope No. 7, Germany), and the uterine cavity is dilated using Glycine solution1.5% and vital signs(Saadat,162 model, non invasive monitoring, Iran), nausea, pain (VAS), analgesic consumption and patient satisfaction(%) at different times are measured. Intervention 2: Intervention group 2: In all patients after entering the operating room, using a 18 intravenous lines, after receiving serum 5 ml/kg of serum Ringer, in spinal anesthesia group, the patient is placed in a sitting position and after determining the subarachnoid space in the L3-L4 or L4-L5 space, 2.5 mg of 0.5% bupivacaine is injected.Then, sensory level is examined by pinprick and in an anesthetic level of T10, the surgical procedure started and 0.02 mg/kg of midazolam and 1ug/kg fentanyl are used for sedation.The patient is then subjected to hysteroscopy with a rigid hysteroscope (Storz Hysteroscope No. 7, Germany), and the uterine cavity is dilated using Glycine solution1.5% and vital signs(Saadat,162 model, non invasive monitoring, Iran), nausea, pain (VAS), analgesic consumption and patient satisfaction(%) at different times are measured. Intervention 3: Intervention group 3: In all patients after entering the operating room, using a 18 intravenous lines, after receiving 5 ml/kg of serum Ringer, in paracervical group, first 0.02mg/kg midazolam and 1ug/kg fentanyl Injected intravenously and after 3-5 minutes, 10 ml lidocaine 2% will inject by a spinal needle no.25 at 3, 9, 5 and 7 hours in cervico vaginal junction, and after 5 minutes, the patient is evaluated for adequate anesthesia and surgery will begin. The patient is then subjected to hysteroscopy with a rigid hysteroscope (Storz Hysteroscope No. 7, Germany), and the uterine cavity is dilated using Glycine solution1.5% and vital signs(Saadat,162 model, non invasive monitoring, Iran), nausea, pain (VAS), analgesic consumption and patient satisfaction(%) at different times are measured. 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 Because the study is not finished yet
public Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street.
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences scientific Nahid Manouchehrian
Fatemieh Hospital,Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 45 years ASA class1&2 Candidate for diagnostic hysteroscopic surgery Satisfaction to participate in the study Do not use analgesics for 24 hours before surgery Absence of contraindications to spinal anesthesia and general anesthesia 18 years 45 years Female History of allergies to local anesthetics and propofol Cardiac,respiratory,renal and liver diseases Candidate patients for myomectomy or polypectomy with resectoscope Electrolyte disturbances (sodium, potassium and calcium Uterine prolapse History of previous cervical or hysteroscopic surgery History of nausea and vomiting following previous anesthesia or history of motion sickness Lack of patient cooperation after initial interventions Coagulation disorders Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: In all patients after entering the operating room, using a 18 intravenous lines, after receiving 5 ml/kg of serum Ringer, in general anesthesia group, 0.02mg/kg midazolam, 1ug ​/kg Fentanyl and 2mg/kg of propofol are injected intravenously and then the suitable LMA is placed (proportional to the patient's weight) and is used to maintain anesthesia from 1.2% isoflurane and 50%N2o.The patient is then subjected to hysteroscopy with a rigid hysteroscope (Storz Hysteroscope No. 7, Germany), and the uterine cavity is dilated using Glycine solution1.5% and vital signs(Saadat,162 model, non invasive monitoring, Iran), nausea, pain (VAS), analgesic consumption and patient satisfaction(%) at different times are measured. Intervention group 2: In all patients after entering the operating room, using a 18 intravenous lines, after receiving serum 5 ml/kg of serum Ringer, in spinal anesthesia group, the patient is placed in a sitting position and after determining the subarachnoid space in the L3-L4 or L4-L5 space, 2.5 mg of 0.5% bupivacaine is injected.Then, sensory level is examined by pinprick and in an anesthetic level of T10, the surgical procedure started and 0.02 mg/kg of midazolam and 1ug/kg fentanyl are used for sedation.The patient is then subjected to hysteroscopy with a rigid hysteroscope (Storz Hysteroscope No. 7, Germany), and the uterine cavity is dilated using Glycine solution1.5% and vital signs(Saadat,162 model, non invasive monitoring, Iran), nausea, pain (VAS), analgesic consumption and patient satisfaction(%) at different times are measured. Intervention group 3: In all patients after entering the operating room, using a 18 intravenous lines, after receiving 5 ml/kg of serum Ringer, in paracervical group, first 0.02mg/kg midazolam and 1ug/kg fentanyl Injected intravenously and after 3-5 minutes, 10 ml lidocaine 2% will inject by a spinal needle no.25 at 3, 9, 5 and 7 hours in cervico vaginal junction, and after 5 minutes, the patient is evaluated for adequate anesthesia and surgery will begin. The patient is then subjected to hysteroscopy with a rigid hysteroscope (Storz Hysteroscope No. 7, Germany), and the uterine cavity is dilated using Glycine solution1.5% and vital signs(Saadat,162 model, non invasive monitoring, Iran), nausea, pain (VAS), analgesic consumption and patient satisfaction(%) at different times are measured. Post operative pain. Timepoint: After surgery in recovery. Method of measurement: Using visual analog scale (VAS). Analgesic requirement. Timepoint: After surgery in recovery. Method of measurement: Based on the amount of analgesia requested by the patient. Systolic and Diastolic Blood Pressure. Timepoint: Before and after general or regional anesthesia, insertion of Spacolom and Tenacolom, dilation of cervix,insertion of hysteroscope, biopsy and extraction of hysteroscope. Method of measurement: Non-invasive automatic barometric device. Nausea & vomiting. Timepoint: After surgery in recovery. Method of measurement: Observation. Heart Rate. Timepoint: Before and after general or regional anesthesia, insertion of Spacolom and Tenacolom, dilation of cervix,insertion of hysteroscope, biopsy and extraction of hysteroscope. Method of measurement: Pulseoximetry. Shivering. Timepoint: After surgery in recovery. Method of measurement: Observation. Satisfaction rate. Timepoint: Before discharge from recovery. Method of measurement: Asking the patient. Hamedan University of Medical Sciences Approved 2021-01-16 Ethics committee of Hamadan University of Medical Sciences Mahdieh Street Hamadan Hamadan Iran (Islamic Republic of)