Delirium, PostoperativePhase 3NCT01283412
Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients
A Phase 3 study testing Dexmedetomidine in people with Delirium, Postoperative, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Postoperative
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2014
- Phase
- Phase 3
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status class I-III
- Aged 60 years or above
- Elective major surgery under general anesthesia
Who cannot join
- ASA-PS>=IV
- Aged under 60 yr old
- Body mass index (BMI) >30
- Neurologic disease
- Cardiac surgery and neurologic surgery
- Anticonvulsant drugs
- Chronic analgesics intake
- Participating in the investigation of another study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Wei Mei, M.D., 00862783663173, wmei@tjh.tjmu.edu.cn
Yuke Tian, M.D., 00862783663173, yktian@tjh.tjmu.edu.cn
About this study
Official title: Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Geriatric Patients Undergoing Major Surgery
Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for reducing of early postoperative delirium and increase postoperative quality of recovery within 24 postoperative hours.
Read the detailed description
After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of adult patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I-III, undergoing selective major surgery under general anesthesia. All the patients were randomly assigned to receive dexmedetomidine or placebo during the operation. The primary outcome measure was postoperative delirium assessed by Nursing Delirium Screening Scale (Nu-DESC) every 8 hours within 24 postoperative hours. The secondary outcome was length of postanesthesia care unit (PACU) stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by quality of recovery (QOR40; maximum score 200)and Post-operative Quality Recovery Scale (PQRS) in the first 24 h after surgery.
- Conditions
- Delirium, Postoperative
- Being tested
- Placebo, Dexmedetomidine
- Keywords
- Delirium, Dexmedetomidine, Adult Patients, Elective Major Surgery, General Anesthesia
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo (saline) iv. during the operation and stoped 30min before end of the surgery
DexmedetomidineDrug
Dexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm P | Active comparator | Placebo infusion Receives: Drug: Placebo |
| Arm D | Experimental | Dexmedetomidine infusion Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
Measured: every 8 hours within 24 postoperative hours
Secondary outcomes (6)
Length of PACU stay
Length of PACU stay (min)
Measured: during PACU stay
hemodynamic parameters
Heart frequency, systolic blood pressure, diastolic blood pressure
Measured: every 5min during operation and every 15min during PACU stay
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting
Measured: 24 postoperative hours
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
Measured: 24 postoperative hours
Postoperative delirium
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
Measured: 1st, 2nd, 3rd postoperative days
Postoperative Stroke
Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).
Measured: 1st, 2nd, 3rd, 7th postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, PostoperativeStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Yuke Tian, M.D., Study chair, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyChuanhan Zhang, MD., Study director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283412
- Sponsor's protocol ID
- TIHMZK02004
- Status last verified
- Nov 2013
- First submitted
- 24 Jan 2011
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Geriatric Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT01283412
- Acronym / sponsor ID
- TIHMZK02004
- Conditions
- Delirium, Postoperative
- Keywords
- Delirium, Dexmedetomidine, Adult Patients, Elective Major Surgery, General Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- First posted
- 26 Jan 2011 (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.
Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for reducing of early postoperative delirium and increase postoperative quality of recovery within 24 postoperative hours.
Detailed description
After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of adult patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I-III, undergoing selective major surgery under general anesthesia. All the patients were randomly assigned to receive dexmedetomidine or placebo during the operation. The primary outcome measure was postoperative delirium assessed by Nursing Delirium Screening Scale (Nu-DESC) every 8 hours within 24 postoperative hours. The secondary outcome was length of postanesthesia care unit (PACU) stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by quality of recovery (QOR40; maximum score 200)and Post-operative Quality Recovery Scale (PQRS) in the first 24 h after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm P | Active comparator | Drug: PlaceboPlacebo infusion |
| Arm D | Experimental | Drug: DexmedetomidineDexmedetomidine infusion |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status class I-III
- Aged 60 years or above
- Elective major surgery under general anesthesia
Key exclusion criteria (8 listed)
- ASA-PS>=IV
- Aged under 60 yr old
- Body mass index (BMI) >30
- Neurologic disease
- Cardiac surgery and neurologic surgery
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 |
|---|---|---|
| PlaceboPlacebo (saline) iv. during the operation and stoped 30min before end of the surgery | Drug | Arm P |
| DexmedetomidineDexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery | Drug | Arm D |
Primary outcome
Postoperative delirium
Time frame: every 8 hours within 24 postoperative hours
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
6 secondary outcomes
Length of PACU stay
Time frame: during PACU stay
hemodynamic parameters
Time frame: every 5min during operation and every 15min during PACU stay
incidence of postoperative nausea and vomiting
Time frame: 24 postoperative hours
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)
Time frame: 24 postoperative hours
Postoperative delirium
Time frame: 1st, 2nd, 3rd postoperative days
Postoperative Stroke
Time frame: 1st, 2nd, 3rd, 7th postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
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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.
Yuke Tian, M.D. study chair
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Chuanhan Zhang, MD. study director
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Delirium, Postoperative, run by Huazhong University of Science and Technology 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 8 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 20 Nov 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Wei Mei, M.D. (00862783663173, wmei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: every 8 hours within 24 postoperative hours). 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 20 Nov 2013.