Major Abdominal SurgeryNCT04923737
Immunomodulatory Effects of Dexmedetomidine Infusion
A study testing Dexmedetomidine and 0.9% sodium chloride in people with Major Abdominal Surgery, run by Alexandria University at 1 site in Egypt.
Trial summary
Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms directly by modulating immune cell function or indirectly by attenuating the stress response, Thus, the choice of anesthetic technique may affect clinical outcomes by perturbing the balance between pro- and anti-inflammatory… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Dexmedetomidine and 0.9% sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to May 2022
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- scheduled for elective laparoscopic major abdominal surgeries;
- ASA class II-III
Who cannot join
- 1- Patients with severe infection or diseases in respiratory system 2- Patients with severe arrhythmia or bradycardia 3- Patients with severe diseases in liver, kidney, endocrine or immune system. 4- Patients with history of uncontrolled hypertension, A-V conduction block. 5- Patients who had administrated the α-adrenergic agonists or β-receptor antagonist.
- 6- Patients who received the chemotherapy, radiotherapy, or immunotherapy within one month before operation 7- Patients who had feverbefore operation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Rehab Abd Elraof Abd Elaziz
Alexandria, 000000
Rehab A. Abd Elaziz, Ass. Prof., 01001073703 ext. 020, trcium2002@yahoo.com
About this study
Official title: Immunomodulatory Effects of Dexmedetomidine Infusion After Laparoscopic Major Abdominal Surgeries: Randomized Controlled Study
Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms directly by modulating immune cell function or indirectly by attenuating the stress response, Thus, the choice of anesthetic technique may affect clinical outcomes by perturbing the balance between pro- and anti-inflammatory responses,anesthetics favoring this delicate balance are thus desirable as their use may reduce postoperative complications and mortality
- Conditions
- Major Abdominal Surgery
- Being tested
- Dexmedetomidine, 0.9% sodium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
patients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h.
0.9% sodium chlorideDrug
patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Active comparator | patients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h. Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion Receives: Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune-modulatory effects
serum concentrations of C-reactive protein (CRP) level ,The pro-inflammatory cytokines interleukin (IL)-1β, and IL-6 and anti-inflammatory cytokines IL-10 will be measured at four times: T0 (before anesthesia), T1 (1 h after surgery), T2 (24 h after surgery) and T4 (72 h after surgery
Measured: three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jan 2022
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab zayed, Alexandria University
- Investigators
- rehab A. Abd Elaziz, Ass.Prof., Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923737
- Sponsor's protocol ID
- 0304767
- Status last verified
- May 2022
- First submitted
- 7 Jun 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Effects of Dexmedetomidine Infusion After Laparoscopic Major Abdominal Surgeries: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04923737
- Acronym / sponsor ID
- 0304767
- Conditions
- Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 11 Jun 2021 (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.
Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms directly by modulating immune cell function or indirectly by attenuating the stress response, Thus, the choice of anesthetic technique may affect clinical outcomes by perturbing the balance between pro- and anti-inflammatory responses,anesthetics favoring this delicate balance are thus desirable as their use may reduce postoperative complications and mortality
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: Dexmedetomidinepatients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h. |
| Control group | Placebo comparator | Drug: 0.9% sodium chloridepatients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- scheduled for elective laparoscopic major abdominal surgeries;
- ASA class II-III
Key exclusion criteria (2 listed)
- 1- Patients with severe infection or diseases in respiratory system 2- Patients with severe arrhythmia or bradycardia 3- Patients with severe diseases in liver, kidney, endocrine or immune system. 4- Patients with history of uncontrolled hypertension, A-V conduction block. 5- Patients who had administrated the α-adrenergic agonists or β-receptor antagonist.
- 6- Patients who received the chemotherapy, radiotherapy, or immunotherapy within one month before operation 7- Patients who had feverbefore operation
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 |
|---|---|---|
| Dexmedetomidinepatients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h. | Drug | Dexmedetomidine group |
| 0.9% sodium chloridepatients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion | Drug | Control group |
Primary outcome
immune-modulatory effects
Time frame: three days after surgery
serum concentrations of C-reactive protein (CRP) level ,The pro-inflammatory cytokines interleukin (IL)-1β, and IL-6 and anti-inflammatory cytokines IL-10 will be measured at four times: T0 (before anesthesia), T1 (1 h after surgery), T2 (24 h after surgery) and T4 (72 h after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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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.
rehab A. Abd Elaziz, Ass.Prof. principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and 0.9% sodium chloride in people with Major Abdominal Surgery, run by Alexandria University at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rehab A. Abd Elaziz, Ass. Prof. (01001073703 ext. 020, trcium2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immune-modulatory effects (time frame: three days after surgery). 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 1 Jun 2022.