Pressor ResponsePhase 4PrecedexNCT06592027
Dexmedetomidine for Attenuation of Pressor Response
A Phase 4 study testing PRECEDEX INJ★ 2ML in people with Pressor Response, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Direct laryngoscopy and tracheal intubation are usually associated by hemodynamic changes due to increased sympathoadrenal activity which could precipitate serious negative effects in compromised patients . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pressor Response
- What is being tested?
- PRECEDEX INJ★ 2ML
- 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 siteEgypt
- Study dates
- 1 Feb 2024to 30 May 2024
- Phase
- Phase 4
- 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
- 1 - ASA physical status 1-2. 2. Age 18- 60 years old of both sexes. 3. Patients undergoing elective surgery under general anesthesia and tracheal intubation.
Who cannot join
- Age \< 18 years and ≥ 60 years
- Pregnancy
- Emergency surgery or full stomach
- Renal or Hepatic patients
- Patients with suspected difficult airway {e.g., high neck circumference, high body mass index (above 30 kg/m2), airway masses, mouth scars, neck scars, limited neck extension or history of snoring.
- Total duration of laryngoscopy will be noted and in cases where duration exceeded 15 sec the case will be excluded from the study.
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- Any patient on regular intake of beta blockers or calcium channel blockers
- Patients with any known hypersensitivity or contraindication to dexmedetomidine,
- Patients with significant neurological, psychiatric, or neuromuscular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Dose of Dexmedetomidine for Attenuation of Endotracheal Intubation Pressor Response Using Cardiometry. a Randomized, Double-blinded Study
Direct laryngoscopy and tracheal intubation are usually associated by hemodynamic changes due to increased sympathoadrenal activity which could precipitate serious negative effects in compromised patients . The pressor response could be blunted by dexmedetomidine which is a selective alpha 2 agonist which might provide hemodynamic stability during tracheal intubation.
Read the detailed description
Various drugs include local anesthetics, beta-blockers, calcium channel blockers, and narcotic analgesics have been tried to blunt the laryngoscopy and intubation response, with varied success. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. Its various effects have led to its increasing use for reducing anesthetic and analgesic requirements in the perioperative period. It inhibits sympathetic activity thus terminating the pain signals and thereby blunts the pressor response associated with laryngoscopy and endotracheal intubation. Electrical cardiometry is recently introduced for assessment of many cardiovascular variables and continuously applicable method of cardiac output (CO), stroke volume (SV), and other hemodynamic parameters monitoring. Its use is growing because it is non-invasive, shows reliability in CO measurements and can be used as a continuous bedside monitor Although different doses of dexmedetomidine (0.5- 2.0 μg/kg) have been used in various studies which suggested its efficacy in blunting the hemodynamic pressor response , However, no studies to the best of our knowledge had incorporated CO monitoring for detection of minimal hemodynamic changes during laryngoscopy and endotracheal intubation which can be best achieved by using Cardiometry monitor.
In this study, we will compare two doses of dexmedetomidine for prophylaxis against pressor response of ETI using cardiometry.
- Conditions
- Pressor Response
- Being tested
- PRECEDEX INJ★ 2ML
- Keywords
- Dexmedetomidine, pressor response, optimum dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRECEDEX INJ★ 2MLDrug
this group will receive single dose of dexmedetomidine 0.5 mcg /kg in 50 ml normal saline over 10 min IV infusion
PRECEDEX INJ★ 2MLDrug
single dose of dexmedetomidine 1 mcg /kg in 50 ml normal saline over 10 min IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | this group will receive single dose of dexmedetomidine 0.5 mcg /kg in 50 ml normal saline over 10 min IV infusion Receives: Drug: PRECEDEX INJ★ 2ML |
| Group B | Active comparator | this group will receive single dose of dexmedetomidine 1 mcg /kg in 50 ml normal saline over 10 min IV infusion Receives: Drug: PRECEDEX INJ★ 2ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate measurment
single measurement after intubation
Measured: after 1 minute of successful tracheal intubation
Secondary outcomes (1)
cardiac output
serial measurements every 1 minute
Measured: from the start of induction of anesthesia till 5 minutes after successful tracheal intubation
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 Feb 2024
- Primary completion1 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressor 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of our study is to assess and compare the efficacy of two different doses of dexmedetomidine (0.5 μg/kg and 1.0 μg/ kg) to find out its optimal dose in attenuation of hemodynamic pressor response to laryngoscopy and intubation with the use of Cardiometry for continuous CO monitoring beat by beat.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira sayed mohamed, Theodor Bilharz Research Institute
- Investigators
- Moshira Sayed Lecturer of anesthesia and intensive care, M.D., Principal investigator, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592027
- Sponsor's protocol ID
- PT (811)
- Acronym
- Precedex
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon request from the principal investigator
Publications
Misra S, Behera BK, Mitra JK, Sahoo AK, Jena SS, Srinivasan A. Effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial. Korean J Anesthesiol. 2021 Apr;74(2):150-157. doi: 10.4097/kja.20153. Epub 2020 May 20.
PubMed 32434291
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
- Optimal Dose of Dexmedetomidine for Attenuation of Endotracheal Intubation Pressor Response Using Cardiometry. a Randomized, Double-blinded Study
- ClinicalTrials.gov ID
- NCT06592027
- Acronym / sponsor ID
- Precedex / PT (811)
- Conditions
- Pressor Response
- Keywords
- Dexmedetomidine, pressor response, optimum dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 May 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.
Direct laryngoscopy and tracheal intubation are usually associated by hemodynamic changes due to increased sympathoadrenal activity which could precipitate serious negative effects in compromised patients . The pressor response could be blunted by dexmedetomidine which is a selective alpha 2 agonist which might provide hemodynamic stability during tracheal intubation.
Detailed description
Various drugs include local anesthetics, beta-blockers, calcium channel blockers, and narcotic analgesics have been tried to blunt the laryngoscopy and intubation response, with varied success. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. Its various effects have led to its increasing use for reducing anesthetic and analgesic requirements in the perioperative period. It inhibits sympathetic activity thus terminating the pain signals and thereby blunts the pressor response associated with laryngoscopy and endotracheal intubation. Electrical cardiometry is recently introduced for assessment of many cardiovascular variables and continuously applicable method of cardiac output (CO), stroke volume (SV), and other hemodynamic parameters monitoring. Its use is growing because it is non-invasive, shows reliability in CO measurements and can be used as a continuous bedside monitor Although different doses of dexmedetomidine (0.5- 2.0 μg/kg) have been used in various studies which suggested its efficacy in blunting the hemodynamic pressor response , However, no studies to the best of our knowledge had incorporated CO monitoring for detection of minimal hemodynamic changes during laryngoscopy and endotracheal intubation which can be best achieved by using Cardiometry monitor.
In this study, we will compare two doses of dexmedetomidine for prophylaxis against pressor response of ETI using 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
- Model description
- The aim of our study is to assess and compare the efficacy of two different doses of dexmedetomidine (0.5 μg/kg and 1.0 μg/ kg) to find out its optimal dose in attenuation of hemodynamic pressor response to laryngoscopy and intubation with the use of Cardiometry for continuous CO monitoring beat by beat.
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: PRECEDEX INJ★ 2MLthis group will receive single dose of dexmedetomidine 0.5 mcg /kg in 50 ml normal saline over 10 min IV infusion |
| Group B | Active comparator | Drug: PRECEDEX INJ★ 2MLthis group will receive single dose of dexmedetomidine 1 mcg /kg in 50 ml normal saline over 10 min IV infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1 - ASA physical status 1-2. 2. Age 18- 60 years old of both sexes. 3. Patients undergoing elective surgery under general anesthesia and tracheal intubation.
Key exclusion criteria (9 listed)
- Age \< 18 years and ≥ 60 years
- Pregnancy
- Emergency surgery or full stomach
- Renal or Hepatic patients
- Patients with suspected difficult airway {e.g., high neck circumference, high body mass index (above 30 kg/m2), airway masses, mouth scars, neck scars, limited neck extension or history of snoring.
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 |
|---|---|---|
| PRECEDEX INJ★ 2MLthis group will receive single dose of dexmedetomidine 0.5 mcg /kg in 50 ml normal saline over 10 min IV infusion | Drug | Group A |
| PRECEDEX INJ★ 2MLsingle dose of dexmedetomidine 1 mcg /kg in 50 ml normal saline over 10 min IV infusion | Drug | Group B |
Primary outcome
Heart rate measurment
Time frame: after 1 minute of successful tracheal intubation
single measurement after intubation
1 secondary outcome
cardiac output
Time frame: from the start of induction of anesthesia till 5 minutes after successful tracheal intubation
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 32434291Misra S, Behera BK, Mitra JK, Sahoo AK, Jena SS, Srinivasan A. Effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial. Korean J Anesthesiol. 2021 Apr;74(2):150-157. doi: 10.4097/kja.20153. Epub 2020 May 20.
- Individual participant dataSharing planned: No. Data will be available upon request from the principal investigator
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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.
Moshira Sayed Lecturer of anesthesia and intensive care, M.D. principal investigator
Theodor Bilharz Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRECEDEX INJ★ 2ML in people with Pressor Response, run by Theodor Bilharz Research Institute 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 1 inclusion and 9 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 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 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?
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?
Heart rate measurment (time frame: after 1 minute of successful tracheal intubation). 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 NCT06592027, which also lists 1 linked publication.
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.