Stress Response During Laryngoscopy IntubationNCT03204006
Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.
A study testing Dexmedetomidine and sterile saline in people with Stress Response During Laryngoscopy Intubation, run by Assiut University at 1 site in Egypt.
Trial summary
Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Stress Response During Laryngoscopy Intubation
- What is being tested?
- Dexmedetomidine and sterile saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Mar 2018to 12 Mar 2020
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Age group 20-60 years
- ASA grade 1 and 2
- control hypertensive patients.
Who cannot join
- - Consent not given
- ASA Grade 3 and 4
- history of myocardial ischemia or infarction, or had an abnormal ECG on admission to the hospital
- Patients with cardiovascular, pulmonary, hepatic, and renal disease.
- Patients on B blockers.
- patients with difficult airway; laryngoscopy and intubation time more than 20 s, or requiring more than two attempts will be exclude from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients
Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.
- Being tested
- Dexmedetomidine, sterile saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine preinduction
sterile salineDrug
normal saline preinduction
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Active comparator | 35 patients will receive dexmedetomidine 0.5 µg/kg was administered intravenously using a syringe pump over 10 min sterile saline pre-induction of anesthesia. Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | 35 patients will receive sterile saline 0.5 µg/kg was administered intravenously using a syringe pump over 10 min pre-induction of anesthesia. Receives: Drug: sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
Measured: through first 15 min post-induction of anesthesia
Secondary outcomes (2)
systolic blood pressure
Measured: through first 15 min post-induction of anesthesia
diastolic blood pressure
Measured: through first 15 min post-induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start8 Mar 2018
- Primary completion8 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Response During Laryngoscopy IntubationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman A. Ismail, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204006
- Sponsor's protocol ID
- 01003060483
- Status last verified
- Mar 2020
- First submitted
- 26 Jun 2017
- Last updated
- 7 Apr 2020
- 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03204006
- Acronym / sponsor ID
- 01003060483
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 8 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 29 Jun 2017 (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.
Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: Dexmedetomidine35 patients will receive dexmedetomidine 0.5 µg/kg was administered intravenously using a syringe pump over 10 min sterile saline pre-induction of anesthesia. |
| Control group | Placebo comparator | Drug: sterile saline35 patients will receive sterile saline 0.5 µg/kg was administered intravenously using a syringe pump over 10 min pre-induction of anesthesia. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - Age group 20-60 years
- ASA grade 1 and 2
- control hypertensive patients.
Key exclusion criteria (6 listed)
- - Consent not given
- ASA Grade 3 and 4
- history of myocardial ischemia or infarction, or had an abnormal ECG on admission to the hospital
- Patients with cardiovascular, pulmonary, hepatic, and renal disease.
- Patients on B blockers.
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine preinduction | Drug | Dexmedetomidine group |
| sterile salinenormal saline preinduction | Drug | Control group |
Primary outcome
heart rate
Time frame: through first 15 min post-induction of anesthesia
2 secondary outcomes
systolic blood pressure
Time frame: through first 15 min post-induction of anesthesia
diastolic blood pressure
Time frame: through first 15 min post-induction of anesthesia
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 7 Apr 2020.
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 Dexmedetomidine and sterile saline in people with Stress Response During Laryngoscopy Intubation, run by Assiut 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 3 inclusion and 6 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 7 Apr 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.
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 (time frame: through first 15 min post-induction of anesthesia). 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 7 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.