Surgical Field Quality Improvement in Spine SurgeriesNCT06587620
Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries
A study testing Tranexamic acid and Dexmedetomidine in people with Surgical Field Quality Improvement in Spine Surgeries, run by Zagazig University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Field Quality Improvement in Spine Surgeries
- What is being tested?
- Tranexamic acid and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of medicine, zagazig university
Zagazig, Elsharqya, 44519
Zagazig University
Zagazig
About this study
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.
Read more
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) :
- 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.
- 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.
- 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.
- Being tested
- Tranexamic acid, Dexmedetomidine, Saline (NaCl 0,9 %) (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
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.
DexmedetomidineDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 240 minuets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Surgical Field Quality Improvement in Spine SurgeriesStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, manal mohamed rashad, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587620
- Sponsor's protocol ID
- 11228-8/10-2023
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31624738Tasbihgou 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.
PubMed 34030806Ruku 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.
PubMed 31602066Kundra 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.
PubMed 31303717Ahmadi 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.
PubMed 36721414Modir 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.
PubMed 34213494
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries
- ClinicalTrials.gov ID
- NCT06587620
- Acronym / sponsor ID
- 11228-8/10-2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) :
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group (group c ) : saline | Placebo comparator | 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. |
| Tranexamic acid group (group T) | Active comparator | Drug: Tranexamic acidStart 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). | Active comparator | Drug: DexmedetomidineStart 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidStart 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 group (group T) |
| DexmedetomidineStart 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 group (group D). |
| 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. | Other | control group (group c ) : saline |
Primary outcome
The effect of tranexamic acid and dexmedetomidine on improving surgical field quality
Time frame: 240 minuets
The visibility of the surgical field was assessed by surgeon using Boezaart scoring system throughout the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31624738Yoo 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.
- Background: PubMed 34030806Tasbihgou 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.
- Background: PubMed 31602066Ruku 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.
- Background: PubMed 31303717Kundra 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.
- Background: PubMed 36721414Ahmadi 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.
- Background: PubMed 34213494Modir 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid and Dexmedetomidine in people with Surgical Field Quality Improvement in Spine Surgeries, run by Zagazig University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of tranexamic acid and dexmedetomidine on improving surgical field quality (time frame: 240 minuets). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06587620, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.