Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries
NCT06587620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2024-09-19
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 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.
Conditions
- Surgical Field Quality Improvement in Spine Surgeries
Interventions
- DRUG
-
Tranexamic acid
Start IV infusion of a loading dose of tranexamic acid 10 mg/kg completed to 50 ml saline over 10 min before induction of anesthesia. IV infusion of tranexamic acid at a dose of 1 mg/kg/h immediately after induction till 15 min before the end of surgery.
- DRUG
-
Dexmedetomidine
Start IV infusion of a loading dose of dexmedetomidine 1ug/kg completed to 50 ml saline over 10 min before induction of anesthesia. IV infusion of dexmedetomidine 0.3-0.7 µg/kg/h immediately after induction to maintain Mean Arterial Pressure (MAP) between 60-70 mmHg till 15 min before the end of surgery.
- OTHER
-
Saline (NaCl 0,9 %) (placebo)
IV infusion of 50 ml saline over 10 min before induction of anesthesia. IV saline infusion immediately after induction till 15 min before the end of surgery.
Sponsors & Collaborators
-
Zagazig University
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2024-06-01
- Completion
- 2024-06-30
Countries
- Egypt
Study Locations
More Related Trials
-
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
NCT03425799 ·Status: TERMINATED ·Phase: PHASE3
-
Role of Tranexamic Acid Versus Uterine Cooling at Caesarean Section
NCT02780245 ·Status: COMPLETED ·Phase: PHASE4
-
Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries
NCT03011866 ·Status: UNKNOWN ·Phase: NA
-
Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section
NCT02739815 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss
NCT06188052 ·Status: RECRUITING ·Phase: PHASE4
-
TXA in Spinal Fusion
NCT04272606 ·Status: COMPLETED ·Phase: PHASE2
-
The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.
NCT03714360 ·Status: COMPLETED ·Phase: PHASE4
-
The Efficacy and Safety of the Loading Dose of Tranexamic Acid in Scoliosis Surgery During Perioperative
NCT04952285 ·Status: COMPLETED
-
Tranexamic Acid in Breast Esthetic Surgery.
NCT05945680 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Tranexamic Acid in Reducing Blood Loss During and After Caesarean Section
NCT02350179 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery
NCT06270407 ·Status: RECRUITING ·Phase: PHASE4
-
Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery
NCT00444470 ·Status: COMPLETED ·Phase: PHASE3
-
Tranexamic Acid in Gender Mastectomy
NCT04372940 ·Status: WITHDRAWN ·Phase: PHASE4
-
Tranexamic Acid Infusion During Elective Spine Surgery
NCT04312880 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE4
-
Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient
NCT05427513 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Tranexamic Acid in Abdominoplasty.
NCT06086444 ·Status: COMPLETED ·Phase: PHASE4
-
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
NCT01728636 ·Status: COMPLETED ·Phase: PHASE2
-
Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery
NCT03849443 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Combined IV and Topical TXA in Major Spine Surgery
NCT04797156 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
NCT00827931 ·Status: COMPLETED ·Phase: PHASE4
-
Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
NCT04622397 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa
NCT02688127 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Tranexamic Acid in Adult Spinal Deformity Surgery
NCT03553186 ·Status: RECRUITING ·Phase: PHASE3
-
Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery
NCT01530399 ·Status: TERMINATED ·Phase: PHASE2
-
Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery
NCT04224116 ·Status: COMPLETED ·Phase: PHASE4