Arteriovenous MalformationPhase 4NCT02552459
Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery
A Phase 4 study testing Sufentanil, dexmedetomidine 1 and dexmedetomidine 2 in people with Arteriovenous Malformation, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arteriovenous Malformation
- What is being tested?
- Sufentanil, dexmedetomidine 1 and dexmedetomidine 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing venous malformation embolization operation through general anesthesia.
- aged 18-65 years old.
- operating time varies 1-4h,and extubation after the operation.
Who cannot join
- long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history.
- known for dexmedetomidine or other drugs allergy in this study.
- cannot communicate.
- preoperative systolic blood pressure <90 mmHg, or the heart rate <50/min.
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: Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study
The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.
Read the detailed description
Sufentanil is a classical drug for postoperative analgesia. Dexmedetomidine is a commonly used α2-adrenergic receptor, and it helps provide sedation, analgesia and inhibition of sympathetic activation. The investigators propose to recruit 120 patients who is undergoing the arteriovenous malformation embolism operation in department of Neurosurgery. Patients will be randomly divided into 4 groups(control group, sufentanil and low dexmedetomidine dose group, sufentanil and middle dexmedetomidine dose group, sufentanil and high dexmedetomidine dose group), then the investigators select post-operative records to determine whether dexmedetomidine can take a positive role in neurosurgical analgesia.
- Conditions
- Arteriovenous Malformation
- Being tested
- Sufentanil, dexmedetomidine 1, dexmedetomidine 2, dexmedetomidine 3
- Keywords
- dexmedetomidine, patient controlled analgesia
- Medical subject headings
- Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Also called Sufentanyl
sufentanil 150μg， intravenous administration during post-operative 72 hours.
dexmedetomidine 1Drug
Also called Dex,Dexmedetomidine
dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation
dexmedetomidine 2Drug
Also called Dex,Dexmedetomidine
dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation
dexmedetomidine 3Drug
Also called Dex,Dexmedetomidine
dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.
| Study group | Role | What they receive |
|---|---|---|
| sufentanil | Active comparator | sufentanil 150μg，intravenous administration during the following 72 hours after operation. Receives: Drug: Sufentanil |
| sufentanil&dexmedetomidine 1 | Experimental | sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation. Receives: Drug: Sufentanil; Drug: dexmedetomidine 1 |
| sufentani&dexmedetomidine 2 | Experimental | sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation. Receives: Drug: Sufentanil; Drug: dexmedetomidine 2 |
| sufentanil&dexmedetomidine 3 | Experimental | sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation. Receives: Drug: Sufentanil; Drug: dexmedetomidine 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on the VAS scale
measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。
Measured: within the following 72 hours after surgery
Secondary outcomes (7)
blood pressure(BP)(mmHg)
measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
Measured: within the following 72 hours after surgery
heart rate(HR) (/min)
measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
Measured: within the following 72 hours after surgery
spO2(%)
measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
Measured: within the following 72 hours after surgery
breath(/min)
measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
Measured: within the following 72 hours after surgery
sedation level on ramsay sedation score
measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
Measured: within the following 72 hours after surgery
vomit times
measure vomit times on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
Measured: within the following 72 hours after surgery
nausea
measure whether nausea exists on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
Measured: within the following 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous MalformationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinxin Shao, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jiang Nan, doctor, Principal investigator, The First Affiliated Hospital, Sun Yat-sen UnniversityShao Xinxin, master, Principal investigator, The First Affiliated Hospital, Sun Yat-sen Unniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552459
- Sponsor's protocol ID
- FirstSunYetSen-jn2015
- Status last verified
- Oct 2016
- First submitted
- 26 May 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02552459
- Acronym / sponsor ID
- FirstSunYetSen-jn2015
- Conditions
- Arteriovenous Malformation
- Keywords
- dexmedetomidine, patient controlled analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Sep 2015 (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.
The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.
Detailed description
Sufentanil is a classical drug for postoperative analgesia. Dexmedetomidine is a commonly used α2-adrenergic receptor, and it helps provide sedation, analgesia and inhibition of sympathetic activation. The investigators propose to recruit 120 patients who is undergoing the arteriovenous malformation embolism operation in department of Neurosurgery. Patients will be randomly divided into 4 groups(control group, sufentanil and low dexmedetomidine dose group, sufentanil and middle dexmedetomidine dose group, sufentanil and high dexmedetomidine dose group), then the investigators select post-operative records to determine whether dexmedetomidine can take a positive role in neurosurgical analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sufentanil | Active comparator | Drug: Sufentanilsufentanil 150μg，intravenous administration during the following 72 hours after operation. |
| sufentanil&dexmedetomidine 1 | Experimental | Drug: Sufentanil, Drug: dexmedetomidine 1sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation. |
| sufentani&dexmedetomidine 2 | Experimental | Drug: Sufentanil, Drug: dexmedetomidine 2sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation. |
| sufentanil&dexmedetomidine 3 | Experimental | Drug: Sufentanil, Drug: dexmedetomidine 3sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing venous malformation embolization operation through general anesthesia.
- aged 18-65 years old.
- operating time varies 1-4h,and extubation after the operation.
Key exclusion criteria (4 listed)
- long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history.
- known for dexmedetomidine or other drugs allergy in this study.
- cannot communicate.
- preoperative systolic blood pressure <90 mmHg, or the heart rate <50/min.
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 |
|---|---|---|
| SufentanilAlso: Sufentanylsufentanil 150μg， intravenous administration during post-operative 72 hours. | Drug | sufentani&dexmedetomidine 2, sufentanil, sufentanil&dexmedetomidine 1, sufentanil&dexmedetomidine 3 |
| dexmedetomidine 1Also: Dex,Dexmedetomidinedexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation | Drug | sufentanil&dexmedetomidine 1 |
| dexmedetomidine 2Also: Dex,Dexmedetomidinedexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation | Drug | sufentani&dexmedetomidine 2 |
| dexmedetomidine 3Also: Dex,Dexmedetomidinedexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h. | Drug | sufentanil&dexmedetomidine 3 |
Primary outcome
Pain on the VAS scale
Time frame: within the following 72 hours after surgery
measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。
7 secondary outcomes
blood pressure(BP)(mmHg)
Time frame: within the following 72 hours after surgery
heart rate(HR) (/min)
Time frame: within the following 72 hours after surgery
spO2(%)
Time frame: within the following 72 hours after surgery
breath(/min)
Time frame: within the following 72 hours after surgery
sedation level on ramsay sedation score
Time frame: within the following 72 hours after surgery
vomit times
Time frame: within the following 72 hours after surgery
nausea
Time frame: within the following 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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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.
Jiang Nan, doctor principal investigator
The First Affiliated Hospital, Sun Yat-sen Unniversity
Shao Xinxin, master principal investigator
The First Affiliated Hospital, Sun Yat-sen Unniversity
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 Sufentanil, dexmedetomidine 1 and dexmedetomidine 2 in people with Arteriovenous Malformation, run by First Affiliated Hospital, Sun Yat-Sen University 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 3 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: status not confirmed, as of the sponsor's last update on 18 Oct 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Yi, master (13632391455 ext. +86, liuyisysu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on the VAS scale (time frame: within the following 72 hours after surgery). 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 18 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.