]>
IRCT20150613022697N9 IRCT 2020-12-04 Mashhad University of Medical Sciences The effect of dexmedetomidine on pain, nausea and vomiting following orthognathic surgery Evaluation of the effect of Preoperative administration of Dexmedetomidine on pain, nausea & vomiting after orthognathic surgery 2020-10-21 anticipated 60 Complete https://irct.ir/trial/52340 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Since the two groups are supposed to have the same sample size, Patients eligible for inclusion will be divided into 2 groups using the Blocked Randomization method by one of the nurses of the relevant ward, who is not aware of the implementation of the study. Random sequences will be generated using the Random Generator program. Based on the random block method, 15 blocks of four-block will be generated for 60 patients. Random allocation concealment will be done using sequentially numbered, sealed, opaque envelopes by an independent person who does not know the study process, Blinding description: In this study, the patient, surgeon, outcome assessor, and statistical analyzer will not be aware of the study groups. Regarding patients, blinding is so that patients will not know if they will receive a drug or a placebo. Regarding the assessor, the operator who delivers the pain questionnaires to the patient and completing the study checklist is not aware of the group assignment. The statistical analyzer will be blinded and all data will be provided in the form of coding to him. Furthermore, the anesthesiologist was aware of the drug types in order to prevent the peri- and postoperative complications. 3 Condition 1: Acute pain. Condition 2: Nausea and vomiting. Intervention 1: Intervention group: In the intervention group, dexmedetomidine vial made by Hospira Co. with the brand name of Precedex, Will be administered intravenously with an induction dose of 1 μg/kg and a maintenance dose of 0.2 µg/kg.h، twenty minutes before the start of orthognathic surgery anesthesia. Intervention 2: Control group: In the control group, Normal Saline 0.9% with the volume equal to a dose of Dexmedetomidine will be administered intravenously, twenty minutes before the start of orthognathic surgery anesthesia. Yes - There is a plan to make this available What will be shared: All collected data would be shared for all researchers after the participants were unidentified. When: The access to data will be started 6 months after publication To whom: The data would only be available for people working in academic institutions. Conditions: It is allowed to use the data for meta-analysis and systematic reviews. Where to obtain: The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad). E-mail: samieerads@mums.ac.ir How to obtain: The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission Comments:
public Sahand Samieerad
Oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 Samieerads@mums.ac.ir Mashhad University of Medical Sciences scientific Sahand Samieerad
Oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 Samieerads@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients between the ages of 18 and 40 Patients with skeletal class 3 deformity who are candidates for bimaxillary orthodontic surgery (maxillary advancement using Lefort 1 osteotomy and mandibular setback surgery by bilateral sagittal split osteotomy (BSSO)) Patients with a Body Mass Index of less than 30 kg / m2 Patients who have completed the informed consent 18 years 40 years Both Patients with a history of drug allergy Patients with a history of Motion Sickness Patients with a history of addiction or psychological problems Patients with a history of hypotension and bradycardia Patients with upper gastrointestinal problems such as gastric ulcer, reflux, pyloric stenosis G89.1 R11 Acute pain, not elsewhere classified Nausea and vomiting Treatment - Drugs Placebo Intervention group: In the intervention group, dexmedetomidine vial made by Hospira Co. with the brand name of Precedex, Will be administered intravenously with an induction dose of 1 μg/kg and a maintenance dose of 0.2 µg/kg.h، twenty minutes before the start of orthognathic surgery anesthesia. Control group: In the control group, Normal Saline 0.9% with the volume equal to a dose of Dexmedetomidine will be administered intravenously, twenty minutes before the start of orthognathic surgery anesthesia. Pain degree. Timepoint: 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively. Method of measurement: Visual analogue scale (VAS) for pain. Presence or absence of nausea. Timepoint: Immediately after recovery and 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively. Method of measurement: scoring (0=non, 1=nausea). Presence or absence of vomiting. Timepoint: Immediately after recovery and 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively. Method of measurement: scoring (0=non, 1=vomiting, 2=vomiting >2 times). Mashhad University of Medical Sciences Approved 2020-09-02 Ethics committee of Mashhad University of Medical Science Ghoreishi building, Daneshghah avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)