Abdominal Cancer SurgeriesPhase 4NCT07214714
Hemodynamic and Cardiac Effects of Dexmedetomidine Versus Fentanyl by Intravenous Infusion as Adjuncts to General Anesthesia in Patients Undergoing Major Abdominal Cancer Surgeries.
A Phase 4 study testing Fentanyl (IV) and Dexmedetomidine in people with Abdominal Cancer Surgeries, run by Assiut University.
Trial summary
________________________________________ Background : Major abdominal cancer surgery is among the most invasive procedures, often associated with extensive tissue damage, severe postoperative pain, and delayed recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer Surgeries
- What is being tested?
- Fentanyl (IV) and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I- III, NYHA class I- II
- Patients subjected to elective major abdominal cancer surgeries.
- The enrolled age will be ≥ 18 years.
Who cannot join
- Unfit for surgery
- Patient refusal
- Body mass index>40 kg/m2
- ASA physical status IV-V, NYHA class III-IV.
- Chronic opioid consumption
- Contraindications to neuraxial block (coagulopathy, infection, or hematological disorders).
- Pregnant women
- Hypersensitivity to any of the used drugs
About this study
________________________________________
Background :
Read more
Major abdominal cancer surgery is among the most invasive procedures, often associated with extensive tissue damage, severe postoperative pain, and delayed recovery. Inadequate pain management can result in adverse physiological responses such as tachycardia, hypertension, prolonged immobility, and extended hospital stay. Moreover, poorly controlled pain may impair immune function and contribute to neuroendocrine, metabolic, gastrointestinal, and cardiopulmonary complications. Therefore, effective analgesia is essential to improve patient outcomes and recovery.
Multimodal analgesia has emerged as the gold standard for managing postoperative pain in major abdominal surgery. It integrates regional techniques (such as epidural or intrathecal analgesia), peripheral nerve blocks (e.g., transversus abdominis plane block), systemic opioids, and non-opioid agents including NSAIDs and acetaminophen. This approach minimizes surgical stress, maintains hemodynamic stability, and facilitates early ambulation and discharge.
Opioids, particularly fentanyl, are widely used as intrathecal adjuvants due to their rapid onset and favorable analgesic profile. However, selective alpha-2 adrenergic receptor agonists such as clonidine and dexmedetomidine are gaining attention for their sedative, analgesic, sympatholytic, and hemodynamic-stabilizing effects. Administered intrathecally, epidurally, or intravenously, they can enhance analgesia while reducing anesthetic requirements without causing profound sedation.
Conventional monitoring with heart rate and non-invasive blood pressure may overlook subtle variations in cardiac output. Electrical cardiometry (ICON®) provides continuous, non-invasive, beat-to-beat measurement of cardiac parameters and has been validated across different patient groups. Accordingly, the present study aims to compare intravenous dexmedetomidine and fentanyl as adjuvants to general anesthesia, focusing on their effects on hemodynamics and cardiac function in major abdominal cancer surgery using electrical cardiometry.
- Conditions
- Abdominal Cancer Surgeries
- Being tested
- Fentanyl (IV), Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (IV)Drug
Patients will receive Fentanyl loading dose of 1 µg/kg over 10 minutes, followed by an infusion of 0.5-1 µg/kg/h.
DexmedetomidineDrug
Patients will receive Dexmedetomidine loading dose of 0.5 µg/kg over 10 minutes, followed by an infusion of 0.3-0.9 µg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Active comparator | Patients will receive Dexmedetomidineloading dose of 0.5 µg/kg over 10 minutes, followed by an infusion of 0.3-0.9 µg/kg/h. Receives: Drug: Dexmedetomidine |
| Group F | Active comparator | Patients will receive Fentanyl loading dose of 1 µg/kg over 10 minutes, followed by an infusion of 0.5-1 µg/kg/h. Receives: Drug: Fentanyl (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output (CO)
cardiac output (CO) measured using the non-invasive ICON® monitor
Measured: 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Cancer SurgeriesStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nariman Khaled Abd Elmontalb Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214714
- Sponsor's protocol ID
- dexmedetomidine versus fentany
- Status last verified
- Oct 2025
- First submitted
- 5 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Cardiac Effects of Dexmedetomidine Versus Fentanyl by Intravenous Infusion as Adjuncts to General Anesthesia in Patients Undergoing Major Abdominal Cancer Surgeries.
- ClinicalTrials.gov ID
- NCT07214714
- Acronym / sponsor ID
- dexmedetomidine versus fentany
- Conditions
- Abdominal Cancer Surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Oct 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.
________________________________________
Background :
Major abdominal cancer surgery is among the most invasive procedures, often associated with extensive tissue damage, severe postoperative pain, and delayed recovery. Inadequate pain management can result in adverse physiological responses such as tachycardia, hypertension, prolonged immobility, and extended hospital stay. Moreover, poorly controlled pain may impair immune function and contribute to neuroendocrine, metabolic, gastrointestinal, and cardiopulmonary complications. Therefore, effective analgesia is essential to improve patient outcomes and recovery.
Multimodal analgesia has emerged as the gold standard for managing postoperative pain in major abdominal surgery. It integrates regional techniques (such as epidural or intrathecal analgesia), peripheral nerve blocks (e.g., transversus abdominis plane block), systemic opioids, and non-opioid agents including NSAIDs and acetaminophen. This approach minimizes surgical stress, maintains hemodynamic stability, and facilitates early ambulation and discharge.
Opioids, particularly fentanyl, are widely used as intrathecal adjuvants due to their rapid onset and favorable analgesic profile. However, selective alpha-2 adrenergic receptor agonists such as clonidine and dexmedetomidine are gaining attention for their sedative, analgesic, sympatholytic, and hemodynamic-stabilizing effects. Administered intrathecally, epidurally, or intravenously, they can enhance analgesia while reducing anesthetic requirements without causing profound sedation.
Conventional monitoring with heart rate and non-invasive blood pressure may overlook subtle variations in cardiac output. Electrical cardiometry (ICON®) provides continuous, non-invasive, beat-to-beat measurement of cardiac parameters and has been validated across different patient groups. Accordingly, the present study aims to compare intravenous dexmedetomidine and fentanyl as adjuvants to general anesthesia, focusing on their effects on hemodynamics and cardiac function in major abdominal cancer surgery using electrical cardiometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Active comparator | Drug: DexmedetomidinePatients will receive Dexmedetomidineloading dose of 0.5 µg/kg over 10 minutes, followed by an infusion of 0.3-0.9 µg/kg/h. |
| Group F | Active comparator | Drug: Fentanyl (IV)Patients will receive Fentanyl loading dose of 1 µg/kg over 10 minutes, followed by an infusion of 0.5-1 µg/kg/h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I- III, NYHA class I- II
- Patients subjected to elective major abdominal cancer surgeries.
- The enrolled age will be ≥ 18 years.
Key exclusion criteria (8 listed)
- Unfit for surgery
- Patient refusal
- Body mass index>40 kg/m2
- ASA physical status IV-V, NYHA class III-IV.
- Chronic opioid consumption
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 |
|---|---|---|
| Fentanyl (IV)Patients will receive Fentanyl loading dose of 1 µg/kg over 10 minutes, followed by an infusion of 0.5-1 µg/kg/h. | Drug | Group F |
| DexmedetomidinePatients will receive Dexmedetomidine loading dose of 0.5 µg/kg over 10 minutes, followed by an infusion of 0.3-0.9 µg/kg/h. | Drug | Group D |
Primary outcome
cardiac output (CO)
Time frame: 24 hour postoperative
cardiac output (CO) measured using the non-invasive ICON® monitor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl (IV) and Dexmedetomidine in people with Abdominal Cancer Surgeries, run by Assiut University.
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 8 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: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
cardiac output (CO) (time frame: 24 hour postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2025.