Blood PressureNCT02155010
Dexmedetomidine in Spinal Anesthesia
A study testing Dexmedetomidine and Dexmedetomidine with heavy bupivacaine in people with Blood Pressure and Anxiety, run by Inje University at 1 site in South Korea.
Trial summary
Patients were randomized into two groups, A group and B group. A group and B group patients are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine, respectively. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Blood Pressure, Anxiety
- What is being tested?
- Dexmedetomidine and Dexmedetomidine with heavy bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 20 - 60 aged patients
- orthopedic operation undergoing spinal anesthesia
Who cannot join
- more than American society of anesthesiologists classification 3
- hypertension
- diabetes mellitus
- heart disease (bradycardia, atrioventricular block)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Effect of Dexmedetomidine on Heavy Bupivacaine Spinal Anesthesia
Patients were randomized into two groups, A group and B group. A group and B group patients are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine, respectively.
The investigators will compare of hemodynamics and patient's comfortability between two groups.
Read the detailed description
A and B group patients will intravenous inject dexmedetomidine 1mcg/kg for 10 minute loading infusion and 0.2mcg/kg/hr for continuous infusion. A group receive intravenous dexmedetomidine after procedure, and B group receive intravenous dexmedetomidine before procedure. Both group patients will hydrate 6 ml/kg crystalloid solution and will evaluated patient's anxiety and comfortability perioperative period. Vital signs will record 5 minutes interval at operating room and post-anesthetic care units.
- Conditions
- Blood Pressure, Anxiety
- Being tested
- Dexmedetomidine, Dexmedetomidine with heavy bupivacaine
- Keywords
- Dexmedetomidine, Spinal anesthesia
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Dexmedetomidine with heavy bupivacaineDrug
Also called Precedex, Marcaine
Dexmedetomidine infusion after IT of heavy bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine Receives: Drug: Dexmedetomidine |
| Dexmedetomidine with heavy bupivacaine | Active comparator | IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine Receives: Drug: Dexmedetomidine with heavy bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypotension
We compare incidence rate of hypotension during infusion of dexmedetomidine
Measured: up to 3 hours
Secondary outcomes (1)
Patient's Anxiety
We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery.
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hwa Lee, Inje University
- Investigators
- Ki Hwa Lee, MD, Principal investigator, Inje University Haeundae Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155010
- Sponsor's protocol ID
- 2014-003
- Status last verified
- Aug 2016
- First submitted
- 22 May 2014
- Last updated
- 26 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available within 3 years of study completion.
Publications
Kang E, Lee KH, Jeon SY, Lee KW, Ko MJ, Kim H, Kim YH, Jung JW. The timing of administration of intravenous dexmedetomidine during lower limb surgery: a randomized controlled trial. BMC Anesthesiol. 2016 Nov 21;16(1):116. doi: 10.1186/s12871-016-0282-2.
PubMed 27871236
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effect of Dexmedetomidine on Heavy Bupivacaine Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02155010
- Acronym / sponsor ID
- 2014-003
- Conditions
- Blood Pressure, Anxiety
- Keywords
- Dexmedetomidine, Spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Posted 26 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients were randomized into two groups, A group and B group. A group and B group patients are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine, respectively.
The investigators will compare of hemodynamics and patient's comfortability between two groups.
Detailed description
A and B group patients will intravenous inject dexmedetomidine 1mcg/kg for 10 minute loading infusion and 0.2mcg/kg/hr for continuous infusion. A group receive intravenous dexmedetomidine after procedure, and B group receive intravenous dexmedetomidine before procedure. Both group patients will hydrate 6 ml/kg crystalloid solution and will evaluated patient's anxiety and comfortability perioperative period. Vital signs will record 5 minutes interval at operating room and post-anesthetic care units.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineIV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine |
| Dexmedetomidine with heavy bupivacaine | Active comparator | Drug: Dexmedetomidine with heavy bupivacaineIV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20 - 60 aged patients
- orthopedic operation undergoing spinal anesthesia
Key exclusion criteria (4 listed)
- more than American society of anesthesiologists classification 3
- hypertension
- diabetes mellitus
- heart disease (bradycardia, atrioventricular block)
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine infusion before intrathecal injection of heavy bupivacaine | Drug | Dexmedetomidine |
| Dexmedetomidine with heavy bupivacaineAlso: Precedex, MarcaineDexmedetomidine infusion after IT of heavy bupivacaine | Drug | Dexmedetomidine with heavy bupivacaine |
Primary outcome
Incidence of Hypotension
Time frame: up to 3 hours
We compare incidence rate of hypotension during infusion of dexmedetomidine
1 secondary outcome
Patient's Anxiety
Time frame: up to 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27871236Kang E, Lee KH, Jeon SY, Lee KW, Ko MJ, Kim H, Kim YH, Jung JW. The timing of administration of intravenous dexmedetomidine during lower limb surgery: a randomized controlled trial. BMC Anesthesiol. 2016 Nov 21;16(1):116. doi: 10.1186/s12871-016-0282-2.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available within 3 years of study completion.
Related trials for Blood Pressure
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruitingObservational study
Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
Hypertension
RecruitingObservational study
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
Blood Pressure Measurement
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
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.
Ki Hwa Lee, MD principal investigator
Inje University Haeundae Paik Hospital
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 Dexmedetomidine with heavy bupivacaine in people with Blood Pressure and Anxiety, run by Inje University at 1 site in South Korea.
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 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 26 Sep 2016. 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 South Korea. 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. 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?
Yes. Results are posted in the registry (first posted 26 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Hypotension (time frame: up to 3 hours). 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 NCT02155010, 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 26 Sep 2016.