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IRCT20141001019359N16 IRCT 2022-11-21 Bojnourd University of Medical Sciences Comparison of the effect of intravenous Dexamethasone injection with Intrathecal injection On Pain and Nausea and Vomiting of patients undergoing Caesarean section Comparison of the effect of intravenous Dexamethasone injection with Intrathecal injection On Pain and Nausea and Vomiting of patients undergoing Caesarean section by Spinal anesthesia with Sufentanil; a double-blind randomized clinical trial 2022-12-20 anticipated 90 Complete https://irct.ir/trial/66927 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling in this study will be that first in order to enter the study patients will be in the form of non-random sampling of the type "available" and then divide them into three groups by randomly assigned blocking using a web-based system. Random blocking at www.randomization.com will be done in 15 blocks of 6. So that in each block, there are 2 people in the first group (A), two people in the second group (B) and two people in the third group (C). After a random sequence was identified in all blocks, cards were written by writing C, B, and A to indicate which group each patient was assigned to, and by someone other than the research team from 1 to 90 in all blocks, respectively. They are numbered and these cards are placed in sealed non-transparent envelopes, respectively. Then, in order to hide the random allocation, when the patient visits, the opaque sealed envelope will be opened and then one by one, it will be determined for each sample of the relevant group, Blinding description: None of the participants in the study will be aware of the randomization list, and in order to conceal the randomization process, the groups will be placed in closed envelopes in the reception area and will be assigned to the eligible individuals who enter the study. Also, to blind the patients to the study groups, all patients will receive all the interventions of the same groups with placebo. in order to make the study double-blind, the data will be measured and recorded by a person who is unaware of the groupings. Also, the preparation of drugs in each group is done by an anesthesiologist, and another anesthesiologist will perform the spinal block, who is unaware of the drugs in each syringe. 3 Condition 1: Pain. Condition 2: Nausea and Vomiting. Intervention 1: Intervention group 1: In combination with the main drug (bupivacaine); patients will receive 25 microgram Sufentanyl and 8 mg Dexamethasone Intrathecally (2cc). Also, immediately after doing the spinal; All patients will receive 2cc of Distilled water intravenously. Intervention 2: Intervention group 2:In combination with the main drug (bupivacaine); patients will receive 25 microgram Sufentanyl and 2cc of Distilled water Intrathecally. Also, immediately after doing the spinal; All patients will receive 8 mg of dexamethasone (2cc) intravenously. Intervention 3: Control group: In combination with the main drug (bupivacaine); patients will receive 25 microgram Sufentanyl and 2cc of Distilled water Intrathecally. Also, immediately after doing the spinal; All patients will receive 2cc of Distilled water intravenously. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Ali Esmaeili
North Khorasan School of Medicine, Bojnurd, iran
Bojnurd Iran (Islamic Republic of) 9416678894 0098583151 dresmaely8@gmail.com Bojnourd University of Medical Sciences scientific Ali Esmaeili
North Khorasan School of Medicine, Bojnurd, iran
Bojnurd Iran (Islamic Republic of) 9416678894 0098583151 dresmaely8@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Patient should not have the Absolute contraindications for spinal anesthesia. The patient should not have a history of previous surgery. The patient should not have mental and psychological problems and peripheral and central neuropathy. The patient should not have cardiovascular problems. ASA I & II Patients must be vigilant 20 years 40 years Female Patients who are addictive or have drug abuse. Patient who has a history of taking beta blockers and Alpha 2-agonists and Calcium Channel Blockers. For any reason, If we have to perform General Anesthesia after Spinal Anesthesia R52.9 R11.2 Pain, unspecified Nausea with vomiting, unspecified Prevention Prevention Placebo Intervention group 1: In combination with the main drug (bupivacaine); patients will receive 25 microgram Sufentanyl and 8 mg Dexamethasone Intrathecally (2cc). Also, immediately after doing the spinal; All patients will receive 2cc of Distilled water intravenously. Intervention group 2:In combination with the main drug (bupivacaine); patients will receive 25 microgram Sufentanyl and 2cc of Distilled water Intrathecally. Also, immediately after doing the spinal; All patients will receive 8 mg of dexamethasone (2cc) intravenously. Control group: In combination with the main drug (bupivacaine); patients will receive 25 microgram Sufentanyl and 2cc of Distilled water Intrathecally. Also, immediately after doing the spinal; All patients will receive 2cc of Distilled water intravenously. Pain after surgery. Timepoint: During recovery, 30 minutes after surgery and then every 30 minutes until the 2th hour, then at 6, 12 and 24 hours after surgery. Method of measurement: Visual Analog Score (VAS). Nausea and Vomiting. Timepoint: During recovery, 30 minutes after surgery and then every 30 minutes until the 2th hour, then at 6, 12 and 24 hours after surgery. Method of measurement: Scale for measuring nausea and vomiting. Level of analgesia. Timepoint: After spinal procedure. Method of measurement: Pin Prink Index. Duration of analgesia. Timepoint: After the patient leaves the operation room. Method of measurement: Clock. Hemodynamic parameters. Timepoint: After performing the spinal technique, in the first 15 minutes every 5 minutes and then every 15 minutes until the end of the surgery. Method of measurement: Using the monitoring device. Medication side effects. Timepoint: From the end of surgery to 24 hours after. Method of measurement: Researcher-made questionnaire. Bojnourd University of Medical Sciences Approved 2022-10-20 Ethics committee of North Khorasan University of Medical Sciences Vice Chancellor for Research of North Khorasan University of Medical Sciences, Bojnurd Bojnurd North Khorasan Iran (Islamic Republic of)