NCT06587620

Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing Tranexamic acid in Surgical Field Quality Improvement in Spine Surgeries in 78 participants. Completed in 30 June 2024.

Timeline

1 December 2023

Primary endpoint
1 June 2024

30 June 2024

Quick facts

Lead sponsor	Zagazig University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	78
Start date	1 December 2023
Primary completion	1 June 2024
Estimated completion	30 June 2024
Sites	2 locations across Egypt

Drugs / interventions tested

• Tranexamic acid (Tranexamic Acid) — full drug profile →
• Dexmedetomidine (dexmedetomidine) — full drug profile →
• Saline (NaCl 0,9 %) (placebo) — full drug profile →

Conditions studied

• Surgical Field Quality Improvement in Spine Surgeries — all drugs for Surgical Field Quality Improvement in Spine Surgeries →

Sponsor

Zagazig University

Who can join

Adults 21 to 60, any sex, with Surgical Field Quality Improvement in Spine Surgeries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 mg/kg over 10 min before induction of

anesthesia, then maintenance IV infusion of tranexamic acid 1mg/kg/h.
3. Dexmedetomidine group (group D): received loading dose of dexmedetomidine 1 μg/kg over 10 min before induction of anesthesia, then maintenance IV infusion of dexmedetomidine 0.3-0.7 μg/kg/h.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.