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

NCT06587620 | Completed

• 1 other identifier: 11228-8/10-2023
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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) :

• 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

Outcome Measures

Primary Outcomes (1)

• The effect of tranexamic acid and dexmedetomidine on improving surgical field quality

  The visibility of the surgical field was assessed by surgeon using Boezaart scoring system throughout the operation

  240 minuets

Study Arms (3)

control group (group c ) : saline

PLACEBO COMPARATOR

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.

Other: Saline (NaCl 0,9 %) (placebo)

Tranexamic acid group (group T)

ACTIVE COMPARATOR

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: Tranexamic acid

Dexmedetomidine group (group D).

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine

Interventions

Tranexamic acid DRUG

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.

Tranexamic acid group (group T)

Dexmedetomidine DRUG

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.

Dexmedetomidine group (group D).

Saline (NaCl 0,9 %) (placebo) OTHER

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.

control group (group c ) : saline

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient consent. 2. Age: 21-60 years old. 3. Physical status: ASA І \& II. 4. BMI: 18.5-30 kg/m2. 5. Type of operations : elective lumbar decompression and fixation surgeries at 2 levels. 6. Time of operation : less than 4 hours. 7. Type of anesthesia : general anesthesia.

You may not qualify if:

• \. known history of allergy to study drugs. 2. Central nervous system disorder and metabolic diseases. 3. History or risk of thrombosis or active thromboembolic disease as deep vein thrombosis and pulmonary embolism. 4. Coagulopathies or taking drugs affecting coagulation ( INR\>1.5 , PLatelets count less than 100.000 per microliter of blood ). 5. Patients on B- blockers.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Faculty of medicine, zagazig university

Zagazig, Elsharqya, 44519, Egypt

Location

Zagazig University

Zagazig, Egypt

Location

Related Publications (6)

• Yoo JS, Ahn J, Karmarkar SS, Lamoutte EH, Singh K. The use of tranexamic acid in spine surgery. Ann Transl Med. 2019 Sep;7(Suppl 5):S172. doi: 10.21037/atm.2019.05.36.

  PMID: 31624738 BACKGROUND

• Tasbihgou SR, Barends CRM, Absalom AR. The role of dexmedetomidine in neurosurgery. Best Pract Res Clin Anaesthesiol. 2021 Jul;35(2):221-229. doi: 10.1016/j.bpa.2020.10.002. Epub 2020 Oct 14.

  PMID: 34030806 BACKGROUND

• Ruku R, Jamwal A, Bhadrala N, Gulati S. Randomized Open-Labelled Comparative Evaluation of the Efficacy of Nitroglycerine, Esmolol and Dexmedetomidine in Producing Controlled Hypotension in Spine Surgeries. Anesth Essays Res. 2019 Jul-Sep;13(3):486-491. doi: 10.4103/aer.AER_78_19.

  PMID: 31602066 BACKGROUND

• Kundra S, Taneja S, Choudhary AK, Katyal S, Garg I, Roy R. Effect of a low-dose dexmedetomidine infusion on intraoperative hemodynamics, anesthetic requirements and recovery profile in patients undergoing lumbar spine surgery. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):248-253. doi: 10.4103/joacp.JOACP_338_18.

  PMID: 31303717 BACKGROUND

• Ahmadi MS, Jahanshahi J, Hashemian F, Salimbahrani AR, Haghi N, Khanlarzadeh E. Comparison of Tranexamic Acid and Dexmedetomidine on Bleeding in Endoscopic Sinus Surgery. Iran J Otorhinolaryngol. 2023 Jan;35(126):49-56. doi: 10.22038/IJORL.2022.64361.3203.

  PMID: 36721414 BACKGROUND

• Modir H, Moshiri E, Naseri N, Faraji F, Almasi-Hashiani A. A randomized parallel design trial of the efficacy and safety of tranexamic acid, dexmedetomidine and nitroglycerin in controlling intraoperative bleeding and improving surgical field quality during septorhinoplasty under general anesthesia. Med Gas Res. 2021 Oct-Dec;11(4):131-137. doi: 10.4103/2045-9912.318857.

  PMID: 34213494 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid; Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (2)