Flap MonitoringDEXFLAPNCT06993740
Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient
A study testing NaCl 0,9% and Dexmedetomidine in people with Flap Monitoring and Inflammation, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.
Trial summary
This double-blinded randomized controlled trial aims to investigate the effect of intraoperative dexmedetomidine administration on early flap viability and microvascular integrity in cancer patients undergoing elective microvascular reconstructive surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Flap Monitoring, Inflammation, Thrombosis
- What is being tested?
- NaCl 0,9% and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Jun 2025to 8 Mar 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18-65 years) diagnosed with cancer who are scheduled to undergo microsurgical flap reconstruction.
- Patients within the age range of 18 to 65 years at the time of enrollment.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Patients with a history of uncontrolled diabetes mellitus.
- Patients diagnosed with chronic kidney disease.
- Patients with known liver failure.
- Patients receiving corticosteroid therapy prior to surgery.
- Patients with uncontrolled hypertension.
- Patients with a history of chemotherapy or radiotherapy prior to surgery.
Show all 10Show fewer
- Patients diagnosed with preoperative sepsis.
- Patients requiring perioperative vasopressor support.
- Patients with a history of prior surgery in the same operative field.
- Patients who decline to participate in the study.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dharmais National Cancer Center Hospital
Jakarta, DKI Jakarta, 11420
About this study
Official title: The Effect of Dexmedetomidine Administration on the Success of Reconstructive Microsurgery in Cancer Patients: A Study of Glycocalyx Integrity, Inflammatory Response, Thrombosis, Angiogenesis, Oxidative Stress, and Tissue Microcirculation
This double-blinded randomized controlled trial aims to investigate the effect of intraoperative dexmedetomidine administration on early flap viability and microvascular integrity in cancer patients undergoing elective microvascular reconstructive surgery. The primary outcome is clinical flap viability within 48 hours postoperatively, assessed using a standardized scoring system based on flap color, temperature, capillary refill time, and tissue turgor. Secondary outcomes include the evaluation of biomarkers related to endothelial glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammation (IL-6, IL-10), thrombosis (PAI-1), and angiogenesis (VEGF), as well as microcirculatory assessment using Sidestream Dark Field (SDF) imaging. The study is designed to determine whether dexmedetomidine improves early surgical outcomes by modulating pathophysiological processes involved in microvascular flap success.
Read the detailed description
Microvascular reconstructive surgery is commonly performed in cancer patients following tumor excision to restore both form and function. However, flap failure remains a major postoperative complication, particularly in oncologic patients who are more susceptible to inflammation, endothelial injury, thrombosis, and impaired tissue perfusion. Recent evidence suggests that anesthetic agents may play a role in modulating microvascular and endothelial responses during surgery, providing opportunities to enhance surgical outcomes.
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist known for its sedative, analgesic, sympatholytic, and anti-inflammatory properties. In addition to its hemodynamic stability profile, dexmedetomidine has demonstrated protective effects on the endothelium and glycocalyx, along with potential benefits in preserving tissue perfusion and reducing inflammatory and thrombotic responses. However, its clinical impact on microvascular flap outcomes in cancer patients undergoing reconstructive surgery has not been well established.
This study is a double-blinded randomized controlled trial involving 60 adult cancer patients (aged 18 to 65 years) undergoing elective microvascular reconstructive surgery. Participants will be randomized into two groups: an intervention group receiving intravenous dexmedetomidine, and a control group receiving normal saline. Both infusions will be prepared in identical syringes to maintain allocation concealment.
The primary outcome of this study is flap viability within the first 48 hours postoperatively, assessed using a standardized clinical scoring system. This scoring incorporates four key parameters: flap color, surface temperature, capillary refill time, and tissue turgor. Each parameter is evaluated to provide an integrated assessment of early microvascular flap function.
The secondary outcomes include exploratory analysis of biological processes related to microvascular integrity and function. These outcomes include the evaluation of biomarkers indicative of endothelial glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammatory activity (IL-6 and IL-10), prothrombotic state (PAI-1), and angiogenesis (VEGF). These markers will be analyzed from plasma and/or flap tissue at defined perioperative time points to better understand the physiological impact of dexmedetomidine.
Furthermore, real-time assessment of tissue microcirculation will be performed using Sidestream Dark Field (SDF) imaging, a non-invasive technique that enables visualization of capillary density and flow quality in the reconstructed flap area. This provides an objective and dynamic measure of tissue-level perfusion and complements the clinical viability scoring.
All patients will undergo general anesthesia induced with fentanyl 2 µg/kg and propofol 1-2 mg/kg. In the intervention group, dexmedetomidine will be administered with a loading dose of 1 µg/kg over 10 minutes, followed by a continuous infusion at 0.4 µg/kg/hour until 48 hours after surgery. The control group will receive a matched volume of normal saline according to the same timeline.
This study is expected to provide new insights into the role of dexmedetomidine in enhancing microvascular outcomes in cancer patients undergoing reconstructive surgery, potentially offering a simple yet impactful strategy to improve flap success and postoperative recovery.
- Conditions
- Flap Monitoring, Inflammation, Thrombosis, Oxidative Stress, Glycocalyx, Anesthesia
- Being tested
- NaCl 0,9%, Dexmedetomidine
- Keywords
- SOD-1, IL-6, IL-10, VEGF, Syndecan-1, Dexmedetomidine, SDF, PAI-1, Flap Failure, Flap Salvage
- Medical subject headings
- Inflammation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 0,9%Drug
Also called Normal Saline
NaCl 0.9% continuous intravenous infusion during microsurgical reconstruction surgery in cancer patients, started after anesthesia induction and maintained intraoperatively and up to 48 hours postoperatively.
DexmedetomidineDrug
Also called Dexmedetomidine Hydrochloride
Dexmedetomidine continuous intravenous infusion during microsurgical reconstruction surgery in cancer patients, started after anesthesia induction and maintained intraoperatively and up to 48 hours postoperatively, titrated to maintain target sedation and hemodynamic stability.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Participants in this arm will receive a continuous intravenous infusion of placebo (normal saline) administered in the same manner and duration as the dexmedetomidine group-starting after anesthesia induction and continuing for up to 48 hours postoperatively. This control infusion allows comparison of clinical and biochemical outcomes without the influence of dexmedetomidine. Receives: Drug: NaCl 0,9% |
| Dexmedetomidine Group | Active comparator | Participants assigned to this arm will receive a continuous intravenous infusion of dexmedetomidine starting after anesthesia induction and maintained throughout the surgical procedure as well as for up to 48 hours postoperatively. The infusion dose will be titrated to achieve target sedation levels while maintaining stable hemodynamics. This extended administration aims to investigate the effects of dexmedetomidine on endothelial glycocalyx preservation, inflammation modulation, thrombosis prevention, angiogenesis promotion, oxidative stress reduction, and improvement of tissue microcirculation during both intraoperative and early postoperative periods. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap Viability Score
Clinical evaluation of flap viability using a standardized scoring system based on four parameters: flap color, surface temperature, capillary refill time, and tissue turgor. Each parameter is scored individually and combined into a composite viability score. The total score reflects the degree of perfusion and tissue viability at 48 hours after microsurgical reconstruction.
Measured: 48 hours postoperatively
Secondary outcomes (7)
Tissue Syndecan-1 Expression
Quantitative evaluation of syndecan-1 expression in flap tissue using immunohistochemistry (IHC) to assess endothelial glycocalyx integrity. Image analysis software will be used for objective quantification.
Measured: Intraoperative tissue sampling
Tissue Superoxide Dismutase 1 (SOD1) Expression
Quantitative analysis of SOD1 expression in flap tissue using IHC, serving as a marker of oxidative stress response. Expression will be measured using image-based digital quantification.
Measured: Intraoperative tissue sampling
Interleukin-6 (IL-6) Level
Measurement of systemic IL-6 concentrations using Electrochemiluminescence Immunoassay (ECLIA) as an indicator of systemic inflammatory response.
Measured: Baseline (preoperative) and 12 hours postoperatively
Interleukin-10 (IL-10) Level
Quantification of serum IL-10 levels using Enzyme-Linked Immunosorbent Assay (ELISA), to evaluate anti-inflammatory cytokine response.
Measured: Baseline (preoperative) and 12 hours postoperatively
Vascular Endothelial Growth Factor (VEGF) Level
Assessment of systemic angiogenic activity by measuring VEGF levels in serum using ELISA.
Measured: Baseline (preoperative) and 12 hours postoperatively
Plasminogen Activator Inhibitor-1 (PAI-1) Level
Measurement of PAI-1 levels in serum using ELISA to evaluate the fibrinolytic balance and thrombotic tendency.
Measured: Baseline (preoperative) and 12 hours postoperatively
Microcirculation Assessment Using Sidestream Dark Field (SDF) Imaging
Evaluation of microcirculatory parameters using SDF imaging, including vessel density, perfused vessel density, and flow pattern. Measurements will be conducted at the sublingual site and in the flap tissue at specified time points to assess systemic and local microcirculatory dynamics.
Measured: Immediate postoperative (sublingual site), 12 hours postoperative (flap tissue), and 48 hours postoperative (flap tissue)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start10 Jun 2025
- Primary completion6 Mar 2026
- Study completion8 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Flap MonitoringStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the impact of perioperative dexmedetomidine administration on the success of microsurgical reconstruction in cancer patients. The intervention group will receive dexmedetomidine infusion during surgery, while the control group will receive a placebo. The study focuses on assessing surgical outcomes, particularly flap survival, alongside biochemical and histological markers related to endothelial glycocalyx integrity, inflammatory response, thrombosis, angiogenesis, oxidative stress, and microcirculatory function.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dharmais National Cancer Center Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gardian Lukman Hakim, Dharmais National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993740
- Sponsor's protocol ID
- DP.04.03/D.XII/5182/2025
- Acronym
- DEXFLAP
- Status last verified
- Jul 2026
- First submitted
- 19 May 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and the limited scope of data use as outlined in the informed consent. The collected data will be used solely for the purposes of this specific clinical study and will not be made publicly available.
Publications
Petersen SM, Greisen G, Hyttel-Sorensen S, Hahn GH. Sidestream dark field images of the microcirculation: intra-observer reliability and correlation between two semi-quantitative methods for determining flow. BMC Med Imaging. 2014 May 6;14:14. doi: 10.1186/1471-2342-14-14.
PubMed 24885423Atmodiwirjo P, Priambodo PS, Dilogo IH. Pengaruh Titrasi Indocyanine Green terhadap Intensitas Fluoresensi pada Perfusi Flap Bebas dalam Menunjang Tindakan Bedah Mikro Rekonstruksi: Tinjauan terhadap Suhu, TcPCO2, TcPO2, Ekspresi HIF-1α, dan Histopatologi Flap. Universitas Indonesia; 2024.
Preidl RHM, Reuss S, Neukam FW, Kesting M, Wehrhan F. Endothelial inflammatory and thrombogenic expression changes in microvascular anastomoses - An immunohistochemical analysis. J Craniomaxillofac Surg. 2021 May;49(5):422-429. doi: 10.1016/j.jcms.2021.02.006. Epub 2021 Feb 12.
PubMed 33608202Chen Z, Shao DH, Mao ZM, Shi LL, Ma XD, Zhang DP. Effect of dexmedetomidine on blood coagulation in patients undergoing radical gastrectomy under general anesthesia: A prospective, randomized controlled clinical trial. Medicine (Baltimore). 2018 Jul;97(27):e11444. doi: 10.1097/MD.0000000000011444.
PubMed 29979445Fang M, He J, Ma X, Li W, Lin D. Protective effects of dexmedetomidine on the survival of random flaps. Biomed Pharmacother. 2020 Aug;128:110261. doi: 10.1016/j.biopha.2020.110261. Epub 2020 May 20.
PubMed 32446114Wijanarko B, Airlangga PS, Fitriati M, Sumartono C, Kriswidyatomo P, Lestari P. Effect of dexmedetomidine administration on malondialdehyde levels in lower extremity surgery using tourniquets. Bali Medical Journal. 2023 May 6;12(2):1459-65.
Li B, Li Y, Tian S, Wang H, Wu H, Zhang A, Gao C. Anti-inflammatory Effects of Perioperative Dexmedetomidine Administered as an Adjunct to General Anesthesia: A Meta-analysis. Sci Rep. 2015 Jul 21;5:12342. doi: 10.1038/srep12342.
PubMed 26196332Hsu TC, Lin CH, Sun FJ, Chen MJ. Postoperative Serum Levels of Interleukin-6 are Affected by Age in Patients with Colorectal Cancer. Int J Gerontol. 2017 Jun;11(2):75-9.
Finke JC, Yang J, Bredell M, Fritschen U von, Glocker MO. Plasma Cytokine and Growth Factor Profiling during Free Flap Transplantation. In: Issues in Flap Surgery. InTech; 2018.
Lei D, Sha Y, Wen S, Xie S, Liu L, Han C. Dexmedetomidine May Reduce IL-6 Level and the Risk of Postoperative Cognitive Dysfunction in Patients After Surgery: A Meta-Analysis. Dose Response. 2020 Feb 5;18(1):1559325820902345. doi: 10.1177/1559325820902345. eCollection 2020 Jan-Mar.
PubMed 32076394Yuki K. The immunomodulatory mechanism of dexmedetomidine. Int Immunopharmacol. 2021 Aug;97:107709. doi: 10.1016/j.intimp.2021.107709. Epub 2021 Apr 29.
PubMed 33933842Abassi Z, Armaly Z, Heyman SN. Glycocalyx Degradation in Ischemia-Reperfusion Injury. Am J Pathol. 2020 Apr;190(4):752-767. doi: 10.1016/j.ajpath.2019.08.019. Epub 2020 Feb 6.
PubMed 32035883Pillinger NL, Kam P. Endothelial glycocalyx: basic science and clinical implications. Anaesth Intensive Care. 2017 May;45(3):295-307. doi: 10.1177/0310057X1704500305.
PubMed 28486888Pang CY, Neligan PC. Flap Pathophysiology and Pharmacology. In: Gurtner GC, Neligan PC, editors. Plastic Surgery, Volume 1: Principles. Fourth Ed. Canada: Elsevier Inc.; 2018. p. 433-443.e7.
Sigaux N, Philouze P, Boucher F, Jacquemart M, Frobert P, Breton P. Efficacy of the postoperative management after microsurgical free tissue transfer. J Stomatol Oral Maxillofac Surg. 2017 Jun;118(3):173-177. doi: 10.1016/j.jormas.2017.03.007. Epub 2017 Apr 5.
PubMed 28391079
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine Administration on the Success of Reconstructive Microsurgery in Cancer Patients: A Study of Glycocalyx Integrity, Inflammatory Response, Thrombosis, Angiogenesis, Oxidative Stress, and Tissue Microcirculation
- ClinicalTrials.gov ID
- NCT06993740
- Acronym / sponsor ID
- DEXFLAP / DP.04.03/D.XII/5182/2025
- Conditions
- Flap Monitoring, Inflammation, Thrombosis, Oxidative Stress, Glycocalyx, Anesthesia
- Keywords
- SOD-1, IL-6, IL-10, VEGF, Syndecan-1, Dexmedetomidine, SDF, PAI-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dharmais National Cancer Center HospitalOther government
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 8 Mar 2026 (actual)
- First posted
- 29 May 2025 (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.
This double-blinded randomized controlled trial aims to investigate the effect of intraoperative dexmedetomidine administration on early flap viability and microvascular integrity in cancer patients undergoing elective microvascular reconstructive surgery. The primary outcome is clinical flap viability within 48 hours postoperatively, assessed using a standardized scoring system based on flap color, temperature, capillary refill time, and tissue turgor. Secondary outcomes include the evaluation of biomarkers related to endothelial glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammation (IL-6, IL-10), thrombosis (PAI-1), and angiogenesis (VEGF), as well as microcirculatory assessment using Sidestream Dark Field (SDF) imaging. The study is designed to determine whether dexmedetomidine improves early surgical outcomes by modulating pathophysiological processes involved in microvascular flap success.
Detailed description
Microvascular reconstructive surgery is commonly performed in cancer patients following tumor excision to restore both form and function. However, flap failure remains a major postoperative complication, particularly in oncologic patients who are more susceptible to inflammation, endothelial injury, thrombosis, and impaired tissue perfusion. Recent evidence suggests that anesthetic agents may play a role in modulating microvascular and endothelial responses during surgery, providing opportunities to enhance surgical outcomes.
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist known for its sedative, analgesic, sympatholytic, and anti-inflammatory properties. In addition to its hemodynamic stability profile, dexmedetomidine has demonstrated protective effects on the endothelium and glycocalyx, along with potential benefits in preserving tissue perfusion and reducing inflammatory and thrombotic responses. However, its clinical impact on microvascular flap outcomes in cancer patients undergoing reconstructive surgery has not been well established.
This study is a double-blinded randomized controlled trial involving 60 adult cancer patients (aged 18 to 65 years) undergoing elective microvascular reconstructive surgery. Participants will be randomized into two groups: an intervention group receiving intravenous dexmedetomidine, and a control group receiving normal saline. Both infusions will be prepared in identical syringes to maintain allocation concealment.
The primary outcome of this study is flap viability within the first 48 hours postoperatively, assessed using a standardized clinical scoring system. This scoring incorporates four key parameters: flap color, surface temperature, capillary refill time, and tissue turgor. Each parameter is evaluated to provide an integrated assessment of early microvascular flap function.
The secondary outcomes include exploratory analysis of biological processes related to microvascular integrity and function. These outcomes include the evaluation of biomarkers indicative of endothelial glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammatory activity (IL-6 and IL-10), prothrombotic state (PAI-1), and angiogenesis (VEGF). These markers will be analyzed from plasma and/or flap tissue at defined perioperative time points to better understand the physiological impact of dexmedetomidine.
Furthermore, real-time assessment of tissue microcirculation will be performed using Sidestream Dark Field (SDF) imaging, a non-invasive technique that enables visualization of capillary density and flow quality in the reconstructed flap area. This provides an objective and dynamic measure of tissue-level perfusion and complements the clinical viability scoring.
All patients will undergo general anesthesia induced with fentanyl 2 µg/kg and propofol 1-2 mg/kg. In the intervention group, dexmedetomidine will be administered with a loading dose of 1 µg/kg over 10 minutes, followed by a continuous infusion at 0.4 µg/kg/hour until 48 hours after surgery. The control group will receive a matched volume of normal saline according to the same timeline.
This study is expected to provide new insights into the role of dexmedetomidine in enhancing microvascular outcomes in cancer patients undergoing reconstructive surgery, potentially offering a simple yet impactful strategy to improve flap success and postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the impact of perioperative dexmedetomidine administration on the success of microsurgical reconstruction in cancer patients. The intervention group will receive dexmedetomidine infusion during surgery, while the control group will receive a placebo. The study focuses on assessing surgical outcomes, particularly flap survival, alongside biochemical and histological markers related to endothelial glycocalyx integrity, inflammatory response, thrombosis, angiogenesis, oxidative stress, and microcirculatory function.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: NaCl 0,9%Participants in this arm will receive a continuous intravenous infusion of placebo (normal saline) administered in the same manner and duration as the dexmedetomidine group-starting after anesthesia induction and continuing for up to 48 hours postoperatively. This control infusion allows comparison of clinical and biochemical outcomes without the influence of dexmedetomidine. |
| Dexmedetomidine Group | Active comparator | Drug: DexmedetomidineParticipants assigned to this arm will receive a continuous intravenous infusion of dexmedetomidine starting after anesthesia induction and maintained throughout the surgical procedure as well as for up to 48 hours postoperatively. The infusion dose will be titrated to achieve target sedation levels while maintaining stable hemodynamics. This extended administration aims to investigate the effects of dexmedetomidine on endothelial glycocalyx preservation, inflammation modulation, thrombosis prevention, angiogenesis promotion, oxidative stress reduction, and improvement of tissue microcirculation during both intraoperative and early postoperative periods. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (aged 18-65 years) diagnosed with cancer who are scheduled to undergo microsurgical flap reconstruction.
- Patients within the age range of 18 to 65 years at the time of enrollment.
- Patients who provide written informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Patients with a history of uncontrolled diabetes mellitus.
- Patients diagnosed with chronic kidney disease.
- Patients with known liver failure.
- Patients receiving corticosteroid therapy prior to surgery.
- Patients with uncontrolled hypertension.
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 |
|---|---|---|
| NaCl 0,9%Also: Normal SalineNaCl 0.9% continuous intravenous infusion during microsurgical reconstruction surgery in cancer patients, started after anesthesia induction and maintained intraoperatively and up to 48 hours postoperatively. | Drug | Placebo Group |
| DexmedetomidineAlso: Dexmedetomidine HydrochlorideDexmedetomidine continuous intravenous infusion during microsurgical reconstruction surgery in cancer patients, started after anesthesia induction and maintained intraoperatively and up to 48 hours postoperatively, titrated to maintain target sedation and hemodynamic stability. | Drug | Dexmedetomidine Group |
Primary outcome
Flap Viability Score
Time frame: 48 hours postoperatively
Clinical evaluation of flap viability using a standardized scoring system based on four parameters: flap color, surface temperature, capillary refill time, and tissue turgor. Each parameter is scored individually and combined into a composite viability score. The total score reflects the degree of perfusion and tissue viability at 48 hours after microsurgical reconstruction.
7 secondary outcomes
Tissue Syndecan-1 Expression
Time frame: Intraoperative tissue sampling
Tissue Superoxide Dismutase 1 (SOD1) Expression
Time frame: Intraoperative tissue sampling
Interleukin-6 (IL-6) Level
Time frame: Baseline (preoperative) and 12 hours postoperatively
Interleukin-10 (IL-10) Level
Time frame: Baseline (preoperative) and 12 hours postoperatively
Vascular Endothelial Growth Factor (VEGF) Level
Time frame: Baseline (preoperative) and 12 hours postoperatively
Plasminogen Activator Inhibitor-1 (PAI-1) Level
Time frame: Baseline (preoperative) and 12 hours postoperatively
Microcirculation Assessment Using Sidestream Dark Field (SDF) Imaging
Time frame: Immediate postoperative (sublingual site), 12 hours postoperative (flap tissue), and 48 hours postoperative (flap tissue)
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 31 Jul 2026.
- Background: PubMed 24885423Petersen SM, Greisen G, Hyttel-Sorensen S, Hahn GH. Sidestream dark field images of the microcirculation: intra-observer reliability and correlation between two semi-quantitative methods for determining flow. BMC Med Imaging. 2014 May 6;14:14. doi: 10.1186/1471-2342-14-14.
- BackgroundAtmodiwirjo P, Priambodo PS, Dilogo IH. Pengaruh Titrasi Indocyanine Green terhadap Intensitas Fluoresensi pada Perfusi Flap Bebas dalam Menunjang Tindakan Bedah Mikro Rekonstruksi: Tinjauan terhadap Suhu, TcPCO2, TcPO2, Ekspresi HIF-1α, dan Histopatologi Flap. Universitas Indonesia; 2024.
- Background: PubMed 33608202Preidl RHM, Reuss S, Neukam FW, Kesting M, Wehrhan F. Endothelial inflammatory and thrombogenic expression changes in microvascular anastomoses - An immunohistochemical analysis. J Craniomaxillofac Surg. 2021 May;49(5):422-429. doi: 10.1016/j.jcms.2021.02.006. Epub 2021 Feb 12.
- Background: PubMed 29979445Chen Z, Shao DH, Mao ZM, Shi LL, Ma XD, Zhang DP. Effect of dexmedetomidine on blood coagulation in patients undergoing radical gastrectomy under general anesthesia: A prospective, randomized controlled clinical trial. Medicine (Baltimore). 2018 Jul;97(27):e11444. doi: 10.1097/MD.0000000000011444.
- Background: PubMed 32446114Fang M, He J, Ma X, Li W, Lin D. Protective effects of dexmedetomidine on the survival of random flaps. Biomed Pharmacother. 2020 Aug;128:110261. doi: 10.1016/j.biopha.2020.110261. Epub 2020 May 20.
- BackgroundWijanarko B, Airlangga PS, Fitriati M, Sumartono C, Kriswidyatomo P, Lestari P. Effect of dexmedetomidine administration on malondialdehyde levels in lower extremity surgery using tourniquets. Bali Medical Journal. 2023 May 6;12(2):1459-65.
- Background: PubMed 26196332Li B, Li Y, Tian S, Wang H, Wu H, Zhang A, Gao C. Anti-inflammatory Effects of Perioperative Dexmedetomidine Administered as an Adjunct to General Anesthesia: A Meta-analysis. Sci Rep. 2015 Jul 21;5:12342. doi: 10.1038/srep12342.
- BackgroundHsu TC, Lin CH, Sun FJ, Chen MJ. Postoperative Serum Levels of Interleukin-6 are Affected by Age in Patients with Colorectal Cancer. Int J Gerontol. 2017 Jun;11(2):75-9.
- BackgroundFinke JC, Yang J, Bredell M, Fritschen U von, Glocker MO. Plasma Cytokine and Growth Factor Profiling during Free Flap Transplantation. In: Issues in Flap Surgery. InTech; 2018.
- Background: PubMed 32076394Lei D, Sha Y, Wen S, Xie S, Liu L, Han C. Dexmedetomidine May Reduce IL-6 Level and the Risk of Postoperative Cognitive Dysfunction in Patients After Surgery: A Meta-Analysis. Dose Response. 2020 Feb 5;18(1):1559325820902345. doi: 10.1177/1559325820902345. eCollection 2020 Jan-Mar.
- Background: PubMed 33933842Yuki K. The immunomodulatory mechanism of dexmedetomidine. Int Immunopharmacol. 2021 Aug;97:107709. doi: 10.1016/j.intimp.2021.107709. Epub 2021 Apr 29.
- Background: PubMed 32035883Abassi Z, Armaly Z, Heyman SN. Glycocalyx Degradation in Ischemia-Reperfusion Injury. Am J Pathol. 2020 Apr;190(4):752-767. doi: 10.1016/j.ajpath.2019.08.019. Epub 2020 Feb 6.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and the limited scope of data use as outlined in the informed consent. The collected data will be used solely for the purposes of this specific clinical study and will not be made publicly available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaCl 0,9% and Dexmedetomidine in people with Flap Monitoring and Inflammation, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.
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 3 inclusion and 10 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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?
Flap Viability Score (time frame: 48 hours postoperatively). 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 NCT06993740, which also lists 19 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 31 Jul 2026.