General AnesthesiaPhase 4NCT01995214
Sevoflurane and Propofol Anesthesia on Postoperative Delirium
A Phase 4 study testing Propofol and Sevoflurane in people with General Anesthesia and Geriatric Patient, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Delirium is defined as an acute onset and fluctuating course of mental status change with inattention and an altered level of consciousness. Delirium in the postoperative period can be divided into emergence delirium and postoperative delirium, based on the time of onset (Silverstein et al., 2007).Postanaesthesia… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- General Anesthesia, Geriatric Patient
- What is being tested?
- Propofol and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists Physical Status classification (ASA_PS) 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
Tongji Hospital
Wuhan, Hubei, 430030
Wei Mei, MD., PhD., 00862783663173, wmei@tjh.tjmu.edu.cn
About this study
Official title: Comparison of Sevoflurane and Propofol Anesthesia on Postoperative Delirium in Geriatric Patients
Delirium is defined as an acute onset and fluctuating course of mental status change with inattention and an altered level of consciousness. Delirium in the postoperative period can be divided into emergence delirium and postoperative delirium, based on the time of onset (Silverstein et al., 2007).Postanaesthesia delirium is a frequent and potentially serious problem affecting the safety of patients and medical personnel. Clinical studies demonstrated that postoperative delirium is associated with worse outcomes such as prolonged hospital stay, postdischarge institutionalization, and increased mortality (Ely et al., 2004a; Thomason et al., 2005; Robinson et al., 2009). Multiple factors may contribute to the development of postoperative delirium, including patient's medical condition, administration of anesthetics or analgesics and degree of operative stress (Yildizeli et al., 2005; Robinson \& Eiseman, 2008; Deiner \& Silverstein, 2009). Sevoflurane anesthesia have been reported to be associated with more emergence delirium in pediatric patients, when compared with propofol anesthesia. It is not clear if propofol anesthesia will benefit the geriatric patients on postoperative delirium, when compared with sevoflurane anesthesia. We hypothesize that propofol anesthesia will reduce the rate of postoperative delirium by 50% when compared with sevoflurane anesthesia.
- Conditions
- General Anesthesia, Geriatric Patient
- Being tested
- Propofol, Sevoflurane
- Keywords
- Postoperative delirium, Geriatric, General anesthesia, Propofol, Sevoflurane
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.
SevofluraneDrug
Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.
| Study group | Role | What they receive |
|---|---|---|
| P | Experimental | Anesthesia maintenance with propofol+remifentanil Receives: Drug: Propofol |
| S | Experimental | Anesthesia maintenance with sevoflurane+remifentanil Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours
Measured: at 24 postoperative hours
Secondary outcomes (6)
Length of postanesthesia care unit (PACU) stay
Length of PACU stay (min)
Measured: up to 2 hours after PACU admitting
Hemodynamic parameters
Hart frequency, systolic blood pressure, diastolic blood pressure
Measured: 5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closure
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting
Measured: 24 postoperative hours
Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score
Quality of recovery determined by QOR-40
Measured: 1,2,3,7 postoperative days
Postoperative delirium
Postoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days
Measured: 2st, 3st, 7st postoperative days
Postoperative Stroke
Postoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS)
Measured: 1st, 2st, 3st, 7st 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 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, 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, MD., PhD., Study chair, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995214
- Sponsor's protocol ID
- TJMZK20130602
- Status last verified
- Nov 2013
- First submitted
- 13 Nov 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sevoflurane and Propofol Anesthesia on Postoperative Delirium in Geriatric Patients
- ClinicalTrials.gov ID
- NCT01995214
- Acronym / sponsor ID
- TJMZK20130602
- Conditions
- General Anesthesia, Geriatric Patient
- Keywords
- Postoperative delirium, Geriatric, General anesthesia, Propofol, Sevoflurane
- Phase
- Phase 4
- 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
- Dec 2013 (estimated)
- First posted
- 26 Nov 2013 (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.
Delirium is defined as an acute onset and fluctuating course of mental status change with inattention and an altered level of consciousness. Delirium in the postoperative period can be divided into emergence delirium and postoperative delirium, based on the time of onset (Silverstein et al., 2007).Postanaesthesia delirium is a frequent and potentially serious problem affecting the safety of patients and medical personnel. Clinical studies demonstrated that postoperative delirium is associated with worse outcomes such as prolonged hospital stay, postdischarge institutionalization, and increased mortality (Ely et al., 2004a; Thomason et al., 2005; Robinson et al., 2009). Multiple factors may contribute to the development of postoperative delirium, including patient's medical condition, administration of anesthetics or analgesics and degree of operative stress (Yildizeli et al., 2005; Robinson \& Eiseman, 2008; Deiner \& Silverstein, 2009). Sevoflurane anesthesia have been reported to be associated with more emergence delirium in pediatric patients, when compared with propofol anesthesia. It is not clear if propofol anesthesia will benefit the geriatric patients on postoperative delirium, when compared with sevoflurane anesthesia. We hypothesize that propofol anesthesia will reduce the rate of postoperative delirium by 50% when compared with sevoflurane anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P | Experimental | Drug: PropofolAnesthesia maintenance with propofol+remifentanil |
| S | Experimental | Drug: SevofluraneAnesthesia maintenance with sevoflurane+remifentanil |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists Physical Status classification (ASA_PS) 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 |
|---|---|---|
| PropofolAnesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring. | Drug | P |
| SevofluraneAnesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring. | Drug | S |
Primary outcome
Postoperative delirium
Time frame: at 24 postoperative hours
Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours
6 secondary outcomes
Length of postanesthesia care unit (PACU) stay
Time frame: up to 2 hours after PACU admitting
Hemodynamic parameters
Time frame: 5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closure
Incidence of postoperative nausea and vomiting
Time frame: 24 postoperative hours
Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score
Time frame: 1,2,3,7 postoperative days
Postoperative delirium
Time frame: 2st, 3st, 7st postoperative days
Postoperative Stroke
Time frame: 1st, 2st, 3st, 7st postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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, MD., PhD. study chair
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 4 study testing Propofol and Sevoflurane in people with General Anesthesia and Geriatric Patient, 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 26 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 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 Wei Mei, MD., PhD (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: at 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 26 Nov 2013.