AnesthesiaNCT02793986
Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.
A study testing propofol and dexmedetomidine in people with Anesthesia and Local Anesthesia, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To offer an satisfied surgery process for patients, a proper sedation is necessary. So in this study, we want to investigate the influence of two different sedative drugs on outcomes of patients received hip replacement surgery . Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Anesthesia, Local Anesthesia
- What is being tested?
- propofol and dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to 29 Jun 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years or older and undergoing hip fracture repair
Who cannot join
- Patients with severe cognitive impairment (MMSE score, <15)
- Preoperative delirium as determined by Confusion Assessment Method
- Contraindications to local anesthesia
- Prior hip surgery
- Mental or language barriers that would preclude data collection
- Severe congestive heart failure (NewYork Heart Association class IV)
- Severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV)
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Anhui Medical University
Hefei, Anhui, 230022
About this study
With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To offer an satisfied surgery process for patients, a proper sedation is necessary. So in this study, we want to investigate the influence of two different sedative drugs on outcomes of patients received hip replacement surgery .
- Conditions
- Anesthesia, Local Anesthesia
- Being tested
- propofol, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
For patients in Group P, the sedation was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml.
dexmedetomidineDrug
For patients in Group D, the sedation was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h. The depth of sedation was considered enough when patient was unresponsive to voice.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine sedation | Experimental | Patients received local anesthesia, in this arm, the sedation of patients was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h. Receives: Drug: dexmedetomidine |
| propofol sedation | Experimental | Patients received local anesthesia, in this arm, the sedation of patients was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Measured: 7 days after surgery
Mortality in 30 days after surgery
Measured: 30 days after surgery
Secondary outcomes (7)
Complications of cardiopulmonary system
Measured: 30 days after surgery
Incidence of cerebrovascular accident
Measured: 30 days after surgery
Out of bed time
Measured: 7 days after surgery
Discharge time
Measured: 30 days after surgery
Dosage of vasoactive agent
Measured: During sugary
Extubation time
Measured: 7 days after surgery
Hemodynamic index
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startAug 2015
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwei Gu, PHD, Study director, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793986
- Sponsor's protocol ID
- PJ2015-07-12
- Status last verified
- Jun 2016
- First submitted
- 4 Jun 2016
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Liu X, Xie G, Zhang K, Song S, Song F, Jin Y, Fang X. Dexmedetomidine vs propofol sedation reduces delirium in patients after cardiac surgery: A meta-analysis with trial sequential analysis of randomized controlled trials. J Crit Care. 2017 Apr;38:190-196. doi: 10.1016/j.jcrc.2016.10.026. Epub 2016 Nov 11.
PubMed 27936404Li X, Yang J, Nie XL, Zhang Y, Li XY, Li LH, Wang DX, Ma D. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: A randomized controlled trial. PLoS One. 2017 Feb 9;12(2):e0170757. doi: 10.1371/journal.pone.0170757. eCollection 2017.
PubMed 28182690Orena EF, King AB, Hughes CG. The role of anesthesia in the prevention of postoperative delirium: a systematic review. Minerva Anestesiol. 2016 Jun;82(6):669-83. Epub 2016 Jan 28.
PubMed 26822815Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
PubMed 27542303
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.
- ClinicalTrials.gov ID
- NCT02793986
- Acronym / sponsor ID
- PJ2015-07-12
- Conditions
- Anesthesia, Local Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 8 Jun 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.
With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To offer an satisfied surgery process for patients, a proper sedation is necessary. So in this study, we want to investigate the influence of two different sedative drugs on outcomes of patients received hip replacement surgery .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine sedation | Experimental | Drug: dexmedetomidinePatients received local anesthesia, in this arm, the sedation of patients was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h. |
| propofol sedation | Experimental | Drug: propofolPatients received local anesthesia, in this arm, the sedation of patients was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years or older and undergoing hip fracture repair
Key exclusion criteria (7 listed)
- Patients with severe cognitive impairment (MMSE score, <15)
- Preoperative delirium as determined by Confusion Assessment Method
- Contraindications to local anesthesia
- Prior hip surgery
- Mental or language barriers that would preclude data collection
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 |
|---|---|---|
| propofolFor patients in Group P, the sedation was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml. | Drug | propofol sedation |
| dexmedetomidineFor patients in Group D, the sedation was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h. The depth of sedation was considered enough when patient was unresponsive to voice. | Drug | dexmedetomidine sedation |
Primary outcome
Incidence of postoperative delirium
Time frame: 7 days after surgery
Mortality in 30 days after surgery
Time frame: 30 days after surgery
7 secondary outcomes
Complications of cardiopulmonary system
Time frame: 30 days after surgery
Incidence of cerebrovascular accident
Time frame: 30 days after surgery
Out of bed time
Time frame: 7 days after surgery
Discharge time
Time frame: 30 days after surgery
Dosage of vasoactive agent
Time frame: During sugary
Extubation time
Time frame: 7 days after surgery
Hemodynamic index
Time frame: intraoperative
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 29 Jun 2017.
- Background: PubMed 27936404Liu X, Xie G, Zhang K, Song S, Song F, Jin Y, Fang X. Dexmedetomidine vs propofol sedation reduces delirium in patients after cardiac surgery: A meta-analysis with trial sequential analysis of randomized controlled trials. J Crit Care. 2017 Apr;38:190-196. doi: 10.1016/j.jcrc.2016.10.026. Epub 2016 Nov 11.
- Background: PubMed 28182690Li X, Yang J, Nie XL, Zhang Y, Li XY, Li LH, Wang DX, Ma D. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: A randomized controlled trial. PLoS One. 2017 Feb 9;12(2):e0170757. doi: 10.1371/journal.pone.0170757. eCollection 2017.
- Background: PubMed 26822815Orena EF, King AB, Hughes CG. The role of anesthesia in the prevention of postoperative delirium: a systematic review. Minerva Anestesiol. 2016 Jun;82(6):669-83. Epub 2016 Jan 28.
- Background: PubMed 27542303Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
- 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.
Erwei Gu, PHD study director
The First Affiliated Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol and dexmedetomidine in people with Anesthesia and Local Anesthesia, run by The First Affiliated Hospital of Anhui Medical 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 1 inclusion and 7 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 29 Jun 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. 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 postoperative delirium (time frame: 7 days after surgery). The study lists 2 primary outcomes in all. 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 NCT02793986, which also lists 4 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 29 Jun 2017.