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IRCT20141009019470N101 IRCT 2020-07-28 Shiraz University of Medical Sciences Comparison of the effects of spinal injection drugs on the duration of spinal anesthesia, complications and effect of spinal anesthesia in cesarean section Comparing the intrathecal effects of sufentanil, fentanyl, and intravenous apotel as adjuvants to bupivacaine on duration, side effects, and efficiency of spinal anesthesia in elective cesarean section 2020-08-02 anticipated 105 Complete https://irct.ir/trial/48337 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be allocated into intervention and control groups by block randomization using sealedenvelope.com site. This will randomly generate a sequence of 35 blocks,3 patients in each.And patients will be placed in each of the three groups according to the randomization list after applying the inclusion criteria. 2-3 cesarean section. Intervention 1: Intervention group1:patients received 10 mg bupivacaine 0.5%, 2 micrograms of sufentanil, 0.1 ml of normal saline , and 200 cc normal saline as placebo intravenously after the umbilical cord removal. Intervention 2: Intervention group 2: patients received 10 mg bupivacaine 0.5%, 10 micrograms of fentanyl, 0.3 ml of normal saline, and 200 cc normal saline as placebo intravenously after the umbilical cord removal. Intervention 3: Intervention group3:patients received 10 mg bupivacaine 0.5% , the infusion of 1 gr apotel, 100 micrograms of fentanyl, and 5 mg of morphine diluted in 200 cc normal saline. 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 Its against our policy.
public Reza Jouybar
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 joybarr@sums.ac.ir Shiraz University of Medical Sciences scientific Reza Jouybar
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 joybarr@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Term pregnancy Age 20 to 30 years Weight 50 - 100 kg Height between 150 -180 cm ASA I-II Elective cesarean section 20 years 30 years Female Patient refusal Localized infection in the lumbar region Use of anti platelet and anticoagulant Allergy to the local anesthetics Addiction to narcotics and nicotine Hypovolemic shock Diabetes Renal failure Coagulation disorder Liver disease Heart diseases History of seizures or any neurological disease, Hypertension Preeclampsia Fetal anomaly, (IUGR), improper growth of the fetus in the uterus, Hemoglobin less than 8, Multiple pregnancies, Non- vertex position O82 Encounter for cesarean delivery without indication Prevention Prevention Prevention Intervention group1:patients received 10 mg bupivacaine 0.5%, 2 micrograms of sufentanil, 0.1 ml of normal saline , and 200 cc normal saline as placebo intravenously after the umbilical cord removal. Intervention group 2: patients received 10 mg bupivacaine 0.5%, 10 micrograms of fentanyl, 0.3 ml of normal saline, and 200 cc normal saline as placebo intravenously after the umbilical cord removal. Intervention group3:patients received 10 mg bupivacaine 0.5% , the infusion of 1 gr apotel, 100 micrograms of fentanyl, and 5 mg of morphine diluted in 200 cc normal saline. Sensory Block. Timepoint: Duration of sensory block. Method of measurement: pin-prick. Motor block. Timepoint: Duration of motor block. Method of measurement: modified Bromage Scale. Pain. Timepoint: Postoperative. Method of measurement: visual analog score. Shiraz University of Medical Sciences Approved 2019-09-02 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)