Perioperative CarePhase 4NCT02768610
Use of Preanesthetic Dexmedetomidine in Elderly, Treated-hypertensive Patients
A Phase 4 study testing Dexmedetomidine and Normal Saline in people with Perioperative Care, run by DongGuk University.
Trial summary
Background: Dexmedetomidine is an alpha 2 adrenergic agonist with sedative, anxiolytic, and analgesic properties. This study was designed to evaluate the inhibitory effects of preoperative 0.5 μg/kg dexmedetomidine on hemodynamic responses caused by endotracheal intubation in elderly patients being treated for… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Perioperative Care
- What is being tested?
- Dexmedetomidine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2016
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- American Society of Anesthesiologists physical status II
- Scheduled for elective noncardiac surgery
- Being treated with anti-hypertensive medication
Who cannot join
- Endotracheal intubation attempted more than twice
- Morbidly obese (BMI > 35 kg/m2)
About this study
Official title: Effects of Preanesthetic Dexmedetomidine on Hemodynamic Responses to Endotracheal Intubation in Elderly Patients Being Treated for Hypertension: A Randomized Trial
Background: Dexmedetomidine is an alpha 2 adrenergic agonist with sedative, anxiolytic, and analgesic properties. This study was designed to evaluate the inhibitory effects of preoperative 0.5 μg/kg dexmedetomidine on hemodynamic responses caused by endotracheal intubation in elderly patients being treated for hypertension.
Methods: Forty elderly (≥ 65 years) treated-hypertensive patients of American Society of Anesthesiologists physical status II undergoing elective noncardiac surgery were randomly and assigned to two groups. Group C received normal saline and group D received 0.5 μg/kg dexmedetomidine intravenously over 10 min just before endotracheal intubation. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) were recorded preoperatively at ward, immediately after study drug administration, and at 1, 3, and 5 minutes after endotracheal intubation.
- Conditions
- Perioperative Care
- Being tested
- Dexmedetomidine, Normal Saline
- Keywords
- dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | 0.5 mcg/kg dexmedetomidine is administered before endotracheal intubation for 10 minutes Receives: Drug: Dexmedetomidine |
| Normal Saline | Placebo comparator | Not described Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in systolic blood pressure
Units of Measure : mmHg
Measured: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Changes in diastolic blood pressure
Units of Measure : mmHg
Measured: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Changes in mean arterial pressure
Units of Measure : mmHg
Measured: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Changes in heart rate
Units of Measure : beats/min
Measured: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative CareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chanwoo Lee, DongGuk University
- Investigators
- Miwoon Kim, M.D., Ph.D., Study director, DongGuk universit hospital Gyeongju hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768610
- Sponsor's protocol ID
- 110757-201602-HR-03-03
- Status last verified
- May 2016
- First submitted
- 5 May 2016
- Last updated
- 11 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preanesthetic Dexmedetomidine on Hemodynamic Responses to Endotracheal Intubation in Elderly Patients Being Treated for Hypertension: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02768610
- Acronym / sponsor ID
- 110757-201602-HR-03-03
- Conditions
- Perioperative Care
- Keywords
- dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 May 2016 (estimated)
- 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: Dexmedetomidine is an alpha 2 adrenergic agonist with sedative, anxiolytic, and analgesic properties. This study was designed to evaluate the inhibitory effects of preoperative 0.5 μg/kg dexmedetomidine on hemodynamic responses caused by endotracheal intubation in elderly patients being treated for hypertension.
Methods: Forty elderly (≥ 65 years) treated-hypertensive patients of American Society of Anesthesiologists physical status II undergoing elective noncardiac surgery were randomly and assigned to two groups. Group C received normal saline and group D received 0.5 μg/kg dexmedetomidine intravenously over 10 min just before endotracheal intubation. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) were recorded preoperatively at ward, immediately after study drug administration, and at 1, 3, and 5 minutes after endotracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: Dexmedetomidine0.5 mcg/kg dexmedetomidine is administered before endotracheal intubation for 10 minutes |
| Normal Saline | Placebo comparator | Drug: Normal Saline |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status II
- Scheduled for elective noncardiac surgery
- Being treated with anti-hypertensive medication
Key exclusion criteria (2 listed)
- Endotracheal intubation attempted more than twice
- Morbidly obese (BMI > 35 kg/m2)
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 | Drug | dexmedetomidine |
| Normal Saline | Drug | Normal Saline |
Primary outcome
Changes in systolic blood pressure
Time frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Units of Measure : mmHg
Changes in diastolic blood pressure
Time frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Units of Measure : mmHg
Changes in mean arterial pressure
Time frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Units of Measure : mmHg
Changes in heart rate
Time frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Units of Measure : beats/min
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 11 May 2016.
Related trials for Perioperative Care
Not yet recruitingPhase 4
Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
Heart Failure, Cardiac Surgery
Recruiting
Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery
Diabetes Type 2
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Recruiting
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Perioperative Care, Intermittent Fasting
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.
Miwoon Kim, M.D., Ph.D. study director
DongGuk universit hospital Gyeongju hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Normal Saline in people with Perioperative Care, run by DongGuk 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 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: finished, as of the sponsor's last update on 11 May 2016. 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. 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?
Changes in systolic blood pressure (time frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation). The study lists 4 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 11 May 2016.