Inflammatory ResponsePhase 3NCT04148599
Effect of IV Infusion of Lidocaine Compared to IV Infusion of Dexmedetomidine on Proinflammatory Cytokines
A Phase 3 study testing dexmedetomidine infusion and lidocaine infusion in people with Inflammatory Response, run by Norma Osama Abdalla Zayed at 1 site in Egypt.
Trial summary
This study is designed to compare between intravenous infusion of dexmedetomidine and intravenous infusion of lidocaine in reduction of proinflammatory cytokines as IL-6 and TNF-α, some stress reactions (serum insulin and serum lactate),and postoperative analgesic requirements in patients undergoing surgery for… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- dexmedetomidine infusion and lidocaine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2018to 13 Jun 2020
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American society of anesthesia (ASA) Physical Status classification:
- ASA II physical status.
- Age between 18 to 60 years old.
- Patients who will undergo major pelviabdominal surgery.
Who cannot join
- Patient refusal.
- Allergy to local anesthetics.
- Cognitive disorders.
- uncontrolled diabetes or hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Infusion of Lidocaine in Comparison to Intravenous Infusion of Dexmedetomidine on Proinflammatory Cytokines and Stress Response in Pelviabdominal Cancer Surgeries
This study is designed to compare between intravenous infusion of dexmedetomidine and intravenous infusion of lidocaine in reduction of proinflammatory cytokines as IL-6 and TNF-α, some stress reactions (serum insulin and serum lactate),and postoperative analgesic requirements in patients undergoing surgery for pelviabdominal cancers.
Read the detailed description
Cancer patients who undergo surgery face many sources of stress. Surgery causes major cytokine and neuroendocrinal changes like increased levels of catecholamine and steroid hormones and other metabolic consequences .This stress response is considered a defense mechanism important for developing resistance to noxious insults.
The cytokine cascade caused by surgical stimulation is complex with various effects on the injured host. Increased production of proinflammatory cytokines from the site of injury causes many systemic changes such as metabolic derangements and hemodynamic instability. Some released cytokines like tumor necrosis factor alpha (TNF-α) and Interleukin 6(IL-6) can cause long lasting hyperalgesia. These proinflammatory cytokines change pain signal transmission through cytokine induced release of some neuroactive substances like nitric oxide, oxygen free radicals and excitatory amino acids. On the other hand anti-inflammatory cytokines are also released during inflammation to counteract these effects and keep balance.
Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that has sedative, analgesic, anesthetic-sparing properties with no respiratory depression. Its anti-inflammatory effects are being studied.
Intravenous lidocaine can be used in management of chronic pain. Lidocaine has anti-inflammatory properties and is capable of reducing postoperative analgesic requirements and the length of hospitalization.
The effect of both drugs on proinflammatory cytokines and stress response will be assessed
- Conditions
- Inflammatory Response
- Being tested
- dexmedetomidine infusion, lidocaine infusion, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine infusionDrug
a loading dose of 1µg/kg of dexmedetomidine (precedex) made to 50 ml using normal saline will be given over 10 minutes followed by infusion of dexmedetomidine with a dose of 0.5µg/kg/hour till the end of surgery.
lidocaine infusionDrug
a loading dose of 1.5 mg/kg of lidocaine made to 50 ml using normal saline and given over 10 minutes followed by infusion of lidocaine with a dose of 1.5 mg/kg/hour till the end of surgery.
PlacebosDrug
50 ml of normal saline given over 10 minutes followed by saline infusion intraoperatively at a rate of 10 ml/hour till the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | dexmedetomidine ( precedex) infusion will be administered preoperatively and continued intraoperatively Receives: Drug: dexmedetomidine infusion |
| lidocaine | Active comparator | Lidocaine (Xylocaine) infusion will be administered preoperatively and continued intraoperatively Receives: Drug: lidocaine infusion |
| placebo | Placebo comparator | saline infusion will be administered preoperatively and continued intraoperatively Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in inflammatory mediators
change in plasma levels of IL-6 (pg/ml), TNF-α (pg/ml)
Measured: preoperative (baseline), immediately postoperative and 24 hours postoperative
change in serum level of insulin and lactate
change in serum levels of insulin (ng/ml) and lactate (ng/ml)
Measured: preoperative (baseline), immediately postoperative and 24 hours postoperative
Secondary outcomes (3)
Rescue analgesia
time of first rescue analgesia
Measured: 1st 24 hours
Visual analogue scale (VAS) score for pain
assessment of postoperative pain using the visual analogue scale score. the scale is a straight horizontal line (100 mm). The ends are defined as the extreme limits of pain orientated from the left (no pain) to the right (worst pain).The patient marks on the line the point that they feel represents their perception of their current state.
The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.higher VAS score means worse pain
Measured: at 0 hour, 2 hour,6 hour, 12 hour and 24 hour
postoperative morphine requirements
total morphine consumption (mg)
Measured: 1st 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start2 Jan 2018
- Primary completion10 Jun 2020
- Study completion13 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norma Osama Abdalla Zayed
- Sponsor type
- University, hospital or other
- Collaborators
- Abdelhamid, Bassant Mohamed, M.D.
- Responsible party
- Sponsor-investigator, Norma Osama Abdalla Zayed, National Cancer Institute, Egypt
- Investigators
- Emad Gerges, MD, Study director, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148599
- Sponsor's protocol ID
- 201617050.3
- Status last verified
- Oct 2019
- First submitted
- 24 Sep 2019
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Infusion of Lidocaine in Comparison to Intravenous Infusion of Dexmedetomidine on Proinflammatory Cytokines and Stress Response in Pelviabdominal Cancer Surgeries
- ClinicalTrials.gov ID
- NCT04148599
- Acronym / sponsor ID
- 201617050.3
- Conditions
- Inflammatory Response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Norma Osama Abdalla ZayedUniversity, hospital or other
- Collaborators
- Abdelhamid, Bassant Mohamed, M.D.
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 13 Jun 2020 (actual)
- First posted
- 1 Nov 2019 (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 study is designed to compare between intravenous infusion of dexmedetomidine and intravenous infusion of lidocaine in reduction of proinflammatory cytokines as IL-6 and TNF-α, some stress reactions (serum insulin and serum lactate),and postoperative analgesic requirements in patients undergoing surgery for pelviabdominal cancers.
Detailed description
Cancer patients who undergo surgery face many sources of stress. Surgery causes major cytokine and neuroendocrinal changes like increased levels of catecholamine and steroid hormones and other metabolic consequences .This stress response is considered a defense mechanism important for developing resistance to noxious insults.
The cytokine cascade caused by surgical stimulation is complex with various effects on the injured host. Increased production of proinflammatory cytokines from the site of injury causes many systemic changes such as metabolic derangements and hemodynamic instability. Some released cytokines like tumor necrosis factor alpha (TNF-α) and Interleukin 6(IL-6) can cause long lasting hyperalgesia. These proinflammatory cytokines change pain signal transmission through cytokine induced release of some neuroactive substances like nitric oxide, oxygen free radicals and excitatory amino acids. On the other hand anti-inflammatory cytokines are also released during inflammation to counteract these effects and keep balance.
Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that has sedative, analgesic, anesthetic-sparing properties with no respiratory depression. Its anti-inflammatory effects are being studied.
Intravenous lidocaine can be used in management of chronic pain. Lidocaine has anti-inflammatory properties and is capable of reducing postoperative analgesic requirements and the length of hospitalization.
The effect of both drugs on proinflammatory cytokines and stress response will be assessed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: dexmedetomidine infusiondexmedetomidine ( precedex) infusion will be administered preoperatively and continued intraoperatively |
| lidocaine | Active comparator | Drug: lidocaine infusionLidocaine (Xylocaine) infusion will be administered preoperatively and continued intraoperatively |
| placebo | Placebo comparator | Drug: Placebossaline infusion will be administered preoperatively and continued intraoperatively |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American society of anesthesia (ASA) Physical Status classification:
- ASA II physical status.
- Age between 18 to 60 years old.
- Patients who will undergo major pelviabdominal surgery.
Key exclusion criteria (4 listed)
- Patient refusal.
- Allergy to local anesthetics.
- Cognitive disorders.
- uncontrolled diabetes or 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 |
|---|---|---|
| dexmedetomidine infusiona loading dose of 1µg/kg of dexmedetomidine (precedex) made to 50 ml using normal saline will be given over 10 minutes followed by infusion of dexmedetomidine with a dose of 0.5µg/kg/hour till the end of surgery. | Drug | dexmedetomidine |
| lidocaine infusiona loading dose of 1.5 mg/kg of lidocaine made to 50 ml using normal saline and given over 10 minutes followed by infusion of lidocaine with a dose of 1.5 mg/kg/hour till the end of surgery. | Drug | lidocaine |
| Placebos50 ml of normal saline given over 10 minutes followed by saline infusion intraoperatively at a rate of 10 ml/hour till the end of surgery. | Drug | placebo |
Primary outcome
change in inflammatory mediators
Time frame: preoperative (baseline), immediately postoperative and 24 hours postoperative
change in plasma levels of IL-6 (pg/ml), TNF-α (pg/ml)
change in serum level of insulin and lactate
Time frame: preoperative (baseline), immediately postoperative and 24 hours postoperative
change in serum levels of insulin (ng/ml) and lactate (ng/ml)
3 secondary outcomes
Rescue analgesia
Time frame: 1st 24 hours
Visual analogue scale (VAS) score for pain
Time frame: at 0 hour, 2 hour,6 hour, 12 hour and 24 hour
postoperative morphine requirements
Time frame: 1st 24 hours
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 3 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Emad Gerges, MD study director
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexmedetomidine infusion and lidocaine infusion in people with Inflammatory Response, run by Norma Osama Abdalla Zayed 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 4 inclusion and 4 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 3 Aug 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in inflammatory mediators (time frame: preoperative (baseline), immediately postoperative and 24 hours postoperative). The study lists 2 primary outcomes in all. 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 3 Aug 2020.