Viewing Study NCT06587620



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Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06587620
Status: COMPLETED
Last Update Posted: None
First Post: 2024-09-04

Brief Title: Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries
Sponsor: None
Organization: None

Study Overview

Official Title: Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries
Status: COMPLETED
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The most common procedure said to involve substantial bleeding is spine surgery There is always a significant danger of bleeding and blood transfusion associated with these procedures particularly complex and multilevel spine surgeries Care of bleeding should be taken as excessive blood loss can lead to impaired vision of surgical field anemia postoperative epidural hematoma and transfusion-related complications as transfusion reactions and transmission of infections

For these reasons improving surgical field is a must Hemostasis procedures including good positioning controlled hypotension local vasoconstrictors epidural block biological and chemical medications including desmopressin aprotinin tranexamic acid epsilon aminocaproic acid dexmedetomidine can all be used to decrease bleeding

and In this study we compared the effect of tranexamic acid and dexmedetomidine on hemodynamics blood loss transfusion and the quality of the surgical field

Sample size was 78 cases who underwent lumbar decompression and fixation surgery at 2 levels They were divided into 3 equal groups 26 patients in each one

1 Control grup group C received loading IV infusion of 50 ml saline over 10 min before induction of anesthesia then maintenance IV infusion of saline
2 Tranexamic acid group group T received loading dose of tranexamic acid 10 mgkg over 10 min before induction of

anesthesia then maintenance IV infusion of tranexamic acid 1mgkgh
3 Dexmedetomidine group group D received loading dose of dexmedetomidine 1 μgkg over 10 min before induction of anesthesia then maintenance IV infusion of dexmedetomidine 03-07 μgkgh

We compared the 3 groups regarding these characteristics - Age sex body mass index and ASA classification

Hemodynamics mean arterial pressure heart rate and oxygen saturation
Amount of blood loss blood transfusion pre and post operative hemoglobin and hematocrit levels
Side effects duration of surgery emergence and discharge times
Score of intraoperative surgical field The results revealed that dexmedetomidine achieved more hypotensive and bradycardiac effects than other study drugs but tranexamic acid had the upper hand in decreasing the amount of blood loss and blood transfusion Side effects were more in dexmedetomidine group than other groups represented mainly as hypotension and bradycardia Duration of surgery was shorter in tranexamic acid group than other groups Emergence and discharge times were longer in dexmedetomidine group than other groups There was no statistical significant difference between the 3 groups in surgical field score
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None