Aneurysm CerebralDACANCT03355534
Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery
A study testing Intravenous dexmedetomidine, nasal dexmedetomidine and intravenous saline in people with Aneurysm Cerebral, run by Zhihong LU at 1 site in China.
Trial summary
Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aneurysm Cerebral
- What is being tested?
- Intravenous dexmedetomidine, nasal dexmedetomidine and intravenous saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2018to 30 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing cerebral aneurysm embolism under general anesthesia
Who cannot join
- patients with bradycardia or atrioventricular heart block
- patients with ASA(American Society of Anesthesiologists) status over 3
- patients with body mass index(BMI)≥30kg/m2
- patients with difficulty in communication
- patients with ruptured aneurysm
- patients suspected or proved to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery
Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of patients undergoing cranial aneurysm surgeries.
- Conditions
- Aneurysm Cerebral
- Being tested
- Intravenous dexmedetomidine, nasal dexmedetomidine, intravenous saline, nasal saline
- Keywords
- dexmedetomidine, general anesthesia, cerebral aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous dexmedetomidineDrug
drug is intravenously infused to patients
nasal dexmedetomidineDrug
drug is nasally given to patients
intravenous salineDrug
saline is given to patients intravenously
nasal salineDrug
normal saline is given to patients nasally
| Study group | Role | What they receive |
|---|---|---|
| nasal dexmedetomidine | Experimental | dexmedetomidine is given nasally, saline is given intravenously Receives: Drug: nasal dexmedetomidine; Drug: intravenous saline |
| intravenous dexmedetomidine | Experimental | saline is given nasally, dexmedetomidine is given intravenously Receives: Drug: Intravenous dexmedetomidine; Drug: nasal saline |
| normal saline | Placebo comparator | saline is given nasally and intravenously Receives: Drug: intravenous saline; Drug: nasal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of coughing
Measured: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Secondary outcomes (8)
Ricker's agitation-sedation score
Measured: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
score of coughing
0=no coughing;1=intermittent coughing;2=continuous coughing
Measured: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
time to response to verbal command
Measured: from end of infusing anesthetics to response to verbal command,averagely 20 minutes
time to extubation
Measured: from end of infusing anesthetics to extubation,averagely 28 minutes
blood pressure before and after extubation
Measured: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
blood glucose before and after aneurysm embolism
Measured: immediately before inserting coil and after finishing inserting coil,an average of 1 hour
blood lactate before and after aneurysm embolism
Measured: immediately before inserting coil and after finishing inserting coil,,an average of 1 hour
Mini-mental state examination score
Measured: 24 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 posted28 Nov 2017
- Study start5 Jan 2018
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aneurysm CerebralStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Lize Xiong, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355534
- Sponsor's protocol ID
- XJH-A-2017-10-10
- Acronym
- DACA
- Status last verified
- May 2022
- First submitted
- 19 Nov 2017
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng K, Wu S, Liu H, Ji F. Dexmedetomidine as an anesthetic adjuvant for intracranial procedures: meta-analysis of randomized controlled trials. J Clin Neurosci. 2014 Nov;21(11):1951-8. doi: 10.1016/j.jocn.2014.02.023. Epub 2014 Jun 25.
PubMed 24974190Soliman RN, Hassan AR, Rashwan AM, Omar AM. Prospective, randomized controlled study to assess the role of dexmedetomidine in patients with supratentorial tumors undergoing craniotomy under general anesthesia. Middle East J Anaesthesiol. 2011 Feb;21(1):23-33.
PubMed 21991729Elbakry AE, Ibrahim E. Propofol-dexmedetomidine versus propofol-remifentanil conscious sedation for awake craniotomy during epilepsy surgery. Minerva Anestesiol. 2017 Dec;83(12):1248-1254. doi: 10.23736/S0375-9393.17.11873-0. Epub 2017 Jun 14.
PubMed 28631453Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.
PubMed 28639236Sun Y, Li Y, Sun Y, Wang X, Ye H, Yuan X. Dexmedetomidine Effect on Emergence Agitation and Delirium in Children Undergoing Laparoscopic Hernia Repair: a Preliminary Study. J Int Med Res. 2017 Jun;45(3):973-983. doi: 10.1177/0300060517699467. Epub 2017 Mar 21.
PubMed 28470100
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery
- ClinicalTrials.gov ID
- NCT03355534
- Acronym / sponsor ID
- DACA / XJH-A-2017-10-10
- Conditions
- Aneurysm Cerebral
- Keywords
- dexmedetomidine, general anesthesia, cerebral aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 28 Nov 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.
Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of patients undergoing cranial aneurysm surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nasal dexmedetomidine | Experimental | Drug: nasal dexmedetomidine, Drug: intravenous salinedexmedetomidine is given nasally, saline is given intravenously |
| intravenous dexmedetomidine | Experimental | Drug: Intravenous dexmedetomidine, Drug: nasal salinesaline is given nasally, dexmedetomidine is given intravenously |
| normal saline | Placebo comparator | Drug: intravenous saline, Drug: nasal salinesaline is given nasally and intravenously |
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 cerebral aneurysm embolism under general anesthesia
Key exclusion criteria (6 listed)
- patients with bradycardia or atrioventricular heart block
- patients with ASA(American Society of Anesthesiologists) status over 3
- patients with body mass index(BMI)≥30kg/m2
- patients with difficulty in communication
- patients with ruptured aneurysm
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 |
|---|---|---|
| Intravenous dexmedetomidinedrug is intravenously infused to patients | Drug | intravenous dexmedetomidine |
| nasal dexmedetomidinedrug is nasally given to patients | Drug | nasal dexmedetomidine |
| intravenous salinesaline is given to patients intravenously | Drug | nasal dexmedetomidine, normal saline |
| nasal salinenormal saline is given to patients nasally | Drug | intravenous dexmedetomidine, normal saline |
Primary outcome
incidence of coughing
Time frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
8 secondary outcomes
Ricker's agitation-sedation score
Time frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
score of coughing
Time frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
time to response to verbal command
Time frame: from end of infusing anesthetics to response to verbal command,averagely 20 minutes
time to extubation
Time frame: from end of infusing anesthetics to extubation,averagely 28 minutes
blood pressure before and after extubation
Time frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
blood glucose before and after aneurysm embolism
Time frame: immediately before inserting coil and after finishing inserting coil,an average of 1 hour
blood lactate before and after aneurysm embolism
Time frame: immediately before inserting coil and after finishing inserting coil,,an average of 1 hour
Mini-mental state examination score
Time frame: 24 hours after surgery
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 26 May 2022.
- Results publication: PubMed 24974190Peng K, Wu S, Liu H, Ji F. Dexmedetomidine as an anesthetic adjuvant for intracranial procedures: meta-analysis of randomized controlled trials. J Clin Neurosci. 2014 Nov;21(11):1951-8. doi: 10.1016/j.jocn.2014.02.023. Epub 2014 Jun 25.
- Results publication: PubMed 21991729Soliman RN, Hassan AR, Rashwan AM, Omar AM. Prospective, randomized controlled study to assess the role of dexmedetomidine in patients with supratentorial tumors undergoing craniotomy under general anesthesia. Middle East J Anaesthesiol. 2011 Feb;21(1):23-33.
- Results publication: PubMed 28631453Elbakry AE, Ibrahim E. Propofol-dexmedetomidine versus propofol-remifentanil conscious sedation for awake craniotomy during epilepsy surgery. Minerva Anestesiol. 2017 Dec;83(12):1248-1254. doi: 10.23736/S0375-9393.17.11873-0. Epub 2017 Jun 14.
- Results publication: PubMed 28639236Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.
- Results publication: PubMed 28470100Sun Y, Li Y, Sun Y, Wang X, Ye H, Yuan X. Dexmedetomidine Effect on Emergence Agitation and Delirium in Children Undergoing Laparoscopic Hernia Repair: a Preliminary Study. J Int Med Res. 2017 Jun;45(3):973-983. doi: 10.1177/0300060517699467. Epub 2017 Mar 21.
- Individual participant dataSharing planned: No
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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.
Lize Xiong study chair
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous dexmedetomidine, nasal dexmedetomidine and intravenous saline in people with Aneurysm Cerebral, run by Zhihong LU 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 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 26 May 2022. 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?
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?
incidence of coughing (time frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes). 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 NCT03355534, which also lists 5 linked publications.
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 May 2022.