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IRCT20210904052371N4 IRCT 2023-08-22 Mazandaran University of Medical Sciences Comparison of the effect of dexmedetomidine and lower dose of neostigmine in pain relief after cesarean section with spinal anesthesia Comparison of the effect of dexmedetomidine and lower dose of neostigmine in pain relief after cesarean section with spinal anesthesia 2023-08-17 anticipated 102 Complete https://irct.ir/trial/71993 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients after choosing and obtaining informed consent to participate in the study after explaining the steps of conducting the research by randomization block method (with various block sizes (multiples of 2)) by computer and online (using the website www .random.org/integres) patients were randomly divided into two groups A and B, each of which had its own code. These codes were written on the final envelope in which the patient group was specified. Without knowing these codes, the research colleagues placed the patients in one of the two groups by selecting each envelope, Blinding description: Blinding will be done in the following way: the project manager (anesthetist) will deliver neostigmine and dexmedetomidine drugs with specific dosage to be added to bupivacaine to the second year anesthesiology assistants (to perform spinal anesthesia). 3 Severity of pain. Intervention 1: Intervention group: 50 micrograms of neostigmine (manufactured by Subhan Pharmaceutical Company, Iran) plus 2.5 cc bupivacaine (manufactured by Elixir Pharmaceutical Company, Iran) 5% will be injected as a single dose in order to evaluate clinical outcomes. Intervention 2: Intervention group: 1 microgram of dexmedetomidine (manufactured by Daro Farah Pharmaceutical Company, Iran) plus 2.5 cc of bupivacaine (manufactured by Elixir Pharmaceutical Company, Iran) 5% will be injected as a single dose in order to evaluate clinical outcomes. 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 Goli Azzi
Amir Mazandarani St. Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 Gaezi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Goli Azzi
Amir Mazandarani St. Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 Gaezi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Women who had an elective cesarean delivery Women who are between 18 and 50 years old. 18 years 50 years Female Patients who refused to participate, or after spinal anesthesia, the required sensory level was not established and were then subjected to general anesthesia. Patients with a history of allergy to any of the drugs used in this research History of drug addiction Moderate or severe heart, kidney, lung or nervous diseases Significant scoliosis or kyphosis Excessive obesity Blood coagulation disease Patients with height less than 130 cm or BMI more than 35 R52 Pain, unspecified Treatment - Drugs Treatment - Drugs Intervention group: 50 micrograms of neostigmine (manufactured by Subhan Pharmaceutical Company, Iran) plus 2.5 cc bupivacaine (manufactured by Elixir Pharmaceutical Company, Iran) 5% will be injected as a single dose in order to evaluate clinical outcomes. Intervention group: 1 microgram of dexmedetomidine (manufactured by Daro Farah Pharmaceutical Company, Iran) plus 2.5 cc of bupivacaine (manufactured by Elixir Pharmaceutical Company, Iran) 5% will be injected as a single dose in order to evaluate clinical outcomes. Intensity of pain. Timepoint: 0, 2, 4, 8 and 12 hours. Method of measurement: Visual Analogue Scale. Sedation rate. Timepoint: Hours 0, 2, 4, 8 and 12. Method of measurement: Using the Ramsay scale. Mazandaran University of Medical Sciences Approved 2023-12-05 Imam (RA) Sari Educational and Medical Hospital - Mazandaran University of Medical Sciences (Researc Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)