AnesthesiaNCT03076099
Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization
A study testing Dexmedetomidine and normal saline in people with Anesthesia, run by Nan Jiang at 1 site in China.
Trial summary
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.
Who cannot join
- abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Sun Yetsen University
Guangzhou, Guangdong, 510080
Yi Liu, Master, +86 13632391455, liuyisysu@126.com
Nan Jiang, professor, +86 20 28823350, NJiang_sysu@126.com
About this study
Official title: Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.
Read the detailed description
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine, normal saline
- Keywords
- Dexmedetomidine, brain arteriovenous malformation, embolization, post-operative hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called DEX
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
normal salineOther
Also called NS
equal volume of normal saline was administered intravenously constantly after tracheal extubation.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly. Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
urapidil consumption
urapidil consumption was recorded by nurses every hour
Measured: the end of the 6th hour after tracheal extubation
Secondary outcomes (17)
urapidil consumption on POD1
urapidil consumption was recorded by nurses every hour
Measured: the total consumption of urapidil on post-operative day 1.
urapidil consumption on POD2
urapidil consumption was recorded by nurses every hour
Measured: the total consumption of urapidil on post-operative day 2.
Visual Analogue score
visual analogue score was measured by visual analogue scale
Measured: the end of the 6th hour after tracheal extubation
Visual Analogue score at 24th hour
visual analogue score was measured by visual analogue scale
Measured: the end of the 24th hour after tracheal extubation
Visual Analogue score at 48th hour
visual analogue score was measured by visual analogue scale
Measured: the end of the 48th hour after tracheal extubation
Quality of Recovery Score
Quality of Recovery Score was measured by a 15-item quality of recovery scale
Measured: the end of the 6th hour after tracheal extubation
Quality of Recovery Score at 24th hour
Quality of Recovery Score was measured by a 15-item quality of recovery scale
Measured: the end of the 24th hour after tracheal extubation
Quality of Recovery Score at 48th hour
Quality of Recovery Score was measured by a 15-item quality of recovery scale
Measured: the end of the 48th hour after tracheal extubation
Analgesics consumption
Analgesics consumption was recorded by nurse every hour
Measured: the end of the 6th hour after tracheal extubation
Analgesics consumption on POD1
Analgesics consumption was recorded by nurse every hour
Measured: the total consumption of urapidil on post-operative day 1.
Analgesics consumption on POD2
Analgesics consumption was recorded by nurse every hour
Measured: the total consumption of urapidil on post-operative day 2.
Bradycardia
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
Measured: the end of the 6th hour after tracheal extubation
Bradycardia at 24th hour
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
Measured: the end of the 24th hour after tracheal extubation
Bradycardia at 48th hour
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
Measured: the end of the 48th hour after tracheal extubation
PONV
post-operative nausea and vomiting (PONV) was recorded by nurse
Measured: the end of the 6th hour after tracheal extubation
PONV at 24th hour
post-operative nausea and vomiting (PONV) was recorded by nurse
Measured: the end of the 24th hour after tracheal extubation
PONV at 48th hour
post-operative nausea and vomiting (PONV) was recorded by nurse
Measured: the end of the 48th hour after tracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nan Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nan Jiang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076099
- Sponsor's protocol ID
- NJiang2016-001
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the IPD will not be shared with others, since following investigations based on this trial is about to start.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization
- ClinicalTrials.gov ID
- NCT03076099
- Acronym / sponsor ID
- NJiang2016-001
- Conditions
- Anesthesia
- Keywords
- Dexmedetomidine, brain arteriovenous malformation, embolization, post-operative hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nan JiangUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 9 Mar 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.
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.
Detailed description
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- two parallel groups
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly. |
| Control group | Placebo comparator | Other: normal salineNormal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.
Key exclusion criteria (1 listed)
- abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
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: DEX1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation. | Drug | Dexmedetomidine |
| normal salineAlso: NSequal volume of normal saline was administered intravenously constantly after tracheal extubation. | Other | Control group |
Primary outcome
urapidil consumption
Time frame: the end of the 6th hour after tracheal extubation
urapidil consumption was recorded by nurses every hour
17 secondary outcomes
urapidil consumption on POD1
Time frame: the total consumption of urapidil on post-operative day 1.
urapidil consumption on POD2
Time frame: the total consumption of urapidil on post-operative day 2.
Visual Analogue score
Time frame: the end of the 6th hour after tracheal extubation
Visual Analogue score at 24th hour
Time frame: the end of the 24th hour after tracheal extubation
Visual Analogue score at 48th hour
Time frame: the end of the 48th hour after tracheal extubation
Quality of Recovery Score
Time frame: the end of the 6th hour after tracheal extubation
Quality of Recovery Score at 24th hour
Time frame: the end of the 24th hour after tracheal extubation
Quality of Recovery Score at 48th hour
Time frame: the end of the 48th hour after tracheal extubation
Analgesics consumption
Time frame: the end of the 6th hour after tracheal extubation
Analgesics consumption on POD1
Time frame: the total consumption of urapidil on post-operative day 1.
Analgesics consumption on POD2
Time frame: the total consumption of urapidil on post-operative day 2.
Bradycardia
Time frame: the end of the 6th hour after tracheal extubation
Bradycardia at 24th hour
Time frame: the end of the 24th hour after tracheal extubation
Bradycardia at 48th hour
Time frame: the end of the 48th hour after tracheal extubation
PONV
Time frame: the end of the 6th hour after tracheal extubation
PONV at 24th hour
Time frame: the end of the 24th hour after tracheal extubation
PONV at 48th hour
Time frame: the end of the 48th hour after tracheal extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Individual participant dataSharing planned: No. the IPD will not be shared with others, since following investigations based on this trial is about to start.
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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.
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 normal saline in people with Anesthesia, run by Nan Jiang at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Jiang, PhD (86 20 28823350, NJiang_sysu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urapidil consumption (time frame: the end of the 6th hour after tracheal extubation). 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 9 Mar 2017.