]>
IRCT20191221045840N1 IRCT 2020-01-20 Qazvin University of Medical Sciences Study of the effect of desmopressin injection on intraoperative hemorrhage of lumbar disc herniation Outcome variable Comparisson of the effect of preoperative intravenous desmopressin on postoperative and during operation blood loss in patients undergoing major spine surgery 2019-12-22 anticipated 55 Complete https://irct.ir/trial/44421 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Basic scienece, Randomization description: In this study, a simple randomization method was used to generate random numbers between 0 and 1 in the software. if the number was above 0.5, the patient is in the intervention group (DDAVP) and if it was below 0.5, he is in the Placebo group. (normal saline), Blinding description: In this study, the sealed envelopes numbered by a predetermined random list are used.in this study, no one including drug delivery nurse, Anesthesiology resident and the person filling the form and surgeons and the person responsible for data analysis is aware of randomization procedure and the patient group. Bioequivalence lumbosacral disc herniation. Intervention 1: The intervention group: DDAVP drug delivered group was desmopressin. Vasopressin Analogue increased Willebrand factor 8. The injected drug was used in this study. The dose of each Ampoule is 4mg / 1 ml. required dose for the patient is 0.3 mg/1 kg of body weight which is poured into 100 ccs normal saline and was injected 10 min during induction. The operation procedure: for all patients the standard technique for lumbar disc surgery provided by 2 surgeons. All patients have a drain for 24 hours. Intervention 2: Control group: Placebo group: in this group, 100 ccs normal saline is Intravenously injected for 10 min during anesthesia. The operation procedure: for all patients the standard technique for lumbar disc surgery provided by 2 surgeons. All patients have a drain for 24 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public ali alizadeh
Qazvin- Bahonar Boulevard- Qazvin University of Medical Sciences
qazvin Iran (Islamic Republic of) 1431634644 +98 21 3327 2257 mahsa.92vafaee@yahoo.com Qazvin University of Medical Sciences scientific ali alizadeh
Qazvin- Bahonar Boulevard- Qazvin University of Medical Sciences
tehran Iran (Islamic Republic of) 1431634644 +98 21 3327 2257 mahsa.92vafaee@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) thoracolumbosacral fracture degenerative lumbosacral disease hypertension & coagulation disorders all types of traumatic patient Consent to enter the research project no limit no limit Both acute heart disease polydipsia chronic heart failure hypothermia chronic kidney disease & end stage renal disease M51.37 Other intervertebral disc degeneration, lumbosacral region Treatment - Drugs Placebo The intervention group: DDAVP drug delivered group was desmopressin. Vasopressin Analogue increased Willebrand factor 8. The injected drug was used in this study. The dose of each Ampoule is 4mg / 1 ml. required dose for the patient is 0.3 mg/1 kg of body weight which is poured into 100 ccs normal saline and was injected 10 min during induction. The operation procedure: for all patients the standard technique for lumbar disc surgery provided by 2 surgeons. All patients have a drain for 24 hours Control group: Placebo group: in this group, 100 ccs normal saline is Intravenously injected for 10 min during anesthesia. The operation procedure: for all patients the standard technique for lumbar disc surgery provided by 2 surgeons. All patients have a drain for 24 hours In this study, the main variable is intra and postoperative hemorrhage. Timepoint: From operation until 24 hours after the operation. Method of measurement: In this study, the intraoperative hemorrhage in Drain and the amount of Gauze consumed was measured and counted in the operating room (each Gauze is equal to 30-50 cc). also, the blood in the drain was measured until 24 hours. Qazvin University of Medical Sciences Approved 2019-12-23 Research Committee of Qazvin University of Medical Sciences Third floor, No. 80, Radouz-e-Rad (1/4) St., Pirouzeh Street, Fatemeh Square, Tehran-Iran tehran Tehran Iran (Islamic Republic of)