Comparisson of the effect of preoperative intravenous desmopressin on postoperative and during operation blood loss in patients undergoing major spine surgery
Examine the effect of desmopressin injection on volume of intra and postoperative hemorrhage in major Scoliosis
Design
A randomized controlled clinical trial
Settings and conduct
This study was conducted in Shahid Rajaee Hospital in Qazvin. The candidate patients for major spine surgery are randomly assigned to one group in case of meeting inclusion criteria and then demographic form including name, height, weight, age, postoperative hemorrhage, number of bloody gauzes (each gas between 30 and 50 ccs), blood in drain after surgery and the amount of required blood for injection are registered. The desmopressin injection procedure is as follows: 0.3 mg / 1 kg of body weight in injected. Surgeon name and operation duration are also registered. After Patient transfer, drain blood is registered for 24 h. in this study, no one is aware of randomization procedure and the patient group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. The patient has Degenerative lumbosacral, 2. Patients consent.
Exclusion criteria: 1. chronic heart disease, 2. Polydipsia. 3- congestive heart failure. 4. Hyponatremia. 5. Moderate to severe renal failure
Intervention groups
The intervention group includes people with Degenerative lumbosacral which are randomly assigned to this group and were delivered desmopressin and intra and postoperative hemorrhage was measured.
The control group includes people with Degenerative lumbosacral which are randomly assigned and delivered placebo (normal saline) and intra and postoperative hemorrhage was measured.
Main outcome variables
evaluation Bleeding rate,Need for blood transfusion, rate of bleeding, duration of operation in patients, duration of hospitalization in patients in placebo and drug groups It doesn't matte
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191221045840N1
Registration date:2020-01-20, 1398/10/30
Registration timing:registered_while_recruiting
Last update:2020-01-20, 1398/10/30
Update count:0
Registration date
2020-01-20, 1398/10/30
Registrant information
Name
Mahsa Vafaeemastanabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 4770
Email address
mahsa.92vafaee@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisson of the effect of preoperative intravenous desmopressin on postoperative and during operation blood loss in patients undergoing major spine surgery
Public title
Study of the effect of desmopressin injection on intraoperative hemorrhage of lumbar disc herniation Outcome variable
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
thoracolumbosacral fracture
degenerative lumbosacral disease
hypertension & coagulation disorders
all types of traumatic patient
Consent to enter the research project
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Committee of Qazvin University of Medical Sciences
Other intervertebral disc degeneration, lumbosacral region
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital of Qazvin
Full name of responsible person
Mahsa Vafaee Mastan Abad
Street address
Tehran, Third Floor, No. 80 Rad Radon (1/4) Street, Pirouzeh Street, Jahad Street (Fatemi Street)