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IRCT20161126031095N5 IRCT 2023-08-10 Mazandaran University of Medical Sciences Comparing the effect of adding dexmedetomidine and low dose of naloxone to morphine on the pain-free period of post-operative analgesia after spinal anesthesia in cesarean section Comparing the effect of adding dexmedetomidine and low dose of naloxone to morphine on the pain-free period of post-operative analgesia after spinal anesthesia in cesarean section 2023-08-12 anticipated 90 Complete https://irct.ir/trial/71896 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be divided based on the basic variables: age and gestational age. The participants will be randomly divided into 3 groups: 1) 100 micrograms of morphine with 2.5 cc of bupivacaine 0.5% plus a low dose of 2 micrograms of naloxone 2) 1 microgram of dexmedetomidine with 2.5 cc of bupivacaine 0.5% 3) 2.5cc bupivacaine 0.5% All syringes containing medicine are transparent and in the same volume and different concentrations which are delivered in sealed envelopes, the patients are divided into three groups A, B and C based on the computer list which is a statistic, there is no information about the people present in the treatment groups the people present in the treatment groups, Blinding description: All the syringes containing drugs are transparent and in the same volume and different concentrations, only the project manager (senior anesthesiology assistant) administers morphine, naloxone and dexmedetomidine drugs with a certain effective dose to add to bupivacaine to the second year anesthesiology assistants. to perform spinal) delivers. The injecting doctor (second-year anesthesiology resident) and the receiving patient are not aware of the content of the injected drug. 3 Intensity of pain. Intervention 1: Intervention group: 100 micrograms of morphine (manufactured by Abu Rehan Company) with 2.5 cc of bupivacaine 0.5% (manufactured by Abu Rehan Pharmaceuticals) plus a low dose of 2 micrograms of naloxone (manufactured by Drug Manufacturing Company) as a single dose by injection. Intervention 2: Intervention group:1 microgram of dexmedetomidine (manufactured by Elixir Pharmaceutical Company) with 2.5 cc of bupivacaine 0.5% (manufactured by Abu Rahian Pharmaceutical Company) as a single dose by injection. Intervention 3: 2.5 cc bupivacaine 0.5% (manufactured by Abu Rahian Pharmaceuticals) intrathecally as a single dose by injection. 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 Alieh Zamani Kiasari
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3335 5080 aliehzamani@yahoo.com Iran University of Medical Sciences scientific Alieh Zamani Kiasari
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3335 5080 aliehzamani@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 50 years Elective cesarean birth for first and second gravid 18 years 50 years Female Patient refusal to participate in the study Failure to create the required level of anesthesia and turning spinal anesthesia into general History of drug addiction History of allergy to any of the drugs used in this research History of known cardiovascular, liver, kidney disease and blood coagulation problems and asthma Scoliosis or kyphosis or morbid obesity Height less than 130 cm and BMI greater than 35 Ketamine or narcotic injection to treat shivering in the second line G89.18 Other acute postprocedural pain Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group: 100 micrograms of morphine (manufactured by Abu Rehan Company) with 2.5 cc of bupivacaine 0.5% (manufactured by Abu Rehan Pharmaceuticals) plus a low dose of 2 micrograms of naloxone (manufactured by Drug Manufacturing Company) as a single dose by injection. Intervention group:1 microgram of dexmedetomidine (manufactured by Elixir Pharmaceutical Company) with 2.5 cc of bupivacaine 0.5% (manufactured by Abu Rahian Pharmaceutical Company) as a single dose by injection 2.5 cc bupivacaine 0.5% (manufactured by Abu Rahian Pharmaceuticals) intrathecally as a single dose by injection Severity of patients' pain. Timepoint: In hours 2, 4, 8, 12 after surgery. Method of measurement: Visual Analogue Scale. Sedation score. Timepoint: In hours 2, 4, 8, 12 after surgery. Method of measurement: Reverse Observer Assessment Scale of Consciousness/Sedation. Mazandaran University of Medical Sciences Approved 2023-02-01 Ethics Committee of Imam Khomeini Educational and Medical Hospital (RA) Sari - Mazandaran University Office Building Ethics Committee of Imam Khomeini Hospital Amir Mazandarani Blvd. Sari Mazandaran Iran (Islamic Republic of)