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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgical Field Quality Improvement in Spine Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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control group (group c ) : saline

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.

Group Type PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type 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.

Tranexamic acid group (group T)

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.

Group Type ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type 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.

Dexmedetomidine group (group D).

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 1\. 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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes