AgingNCT02857153
Effect of High vs. Low MAP Levels on Clinical Outcomes in Elderly Patients During Noncardiothoracic Surgery
A study testing Urapidil, Phenylephrine and Low-level MAP in people with Aging and Surgery, run by Hu Anmin at 7 sites in China.
Trial summary
This will be a multicentre, randomised, controlled and prospective clinical trial. All participants provided their written informed consent to participate in a randomized trial that examined the effects of low-level MAP (60-70 mmHg) vs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Surgery, Blood Pressure
- What is being tested?
- Urapidil, Phenylephrine and Low-level MAP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 7 sitesChina
- Study dates
- Jul 2016to Oct 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- male and females, American Society of Anesthesiologists I-II-III, 65 or more years of age, scheduled to undergo noncardiothoracic surgery with general anesthesia are enrolled.
Who cannot join
- the patient suffered from Cardiovascular Disease and Metabolic Diseases, such as hypertension, cardiac disease, diabetes;
- the patient has severe liver, kidney or blood disease;
- the patient is accompanied severe cognitive impairment (Mini-Mental State Examination (MMSE) score < 15);
- preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, or levodopa treatment;
- use of haloperidol or other neuroleptics during or after anesthesia;
- neurosurgery;
- individuals unlikely to survive for >24 hrs; previous participation in this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
West China Hospital affiliated to Sichuan University
Chengdu, Sichuan, 610000
Qiu Yan, M.S, 18980606269, 12395299@qq.com
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 641000
Zhang Peng, Ph.D, 15902891950, 583559085@qq.com
- Recruiting
The affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Hu Bolong, M.S, 375896605@qq.com
- Recruiting
The Third Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Zhao Rui, M.S, 18388231643, 635741914@qq.com
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518001
Hu Anmin, M.S, 18026980789, toanmin@163.com
Gong Xiaolei, M.S
- Recruiting
Taihe Hospital affiliated to Hubei University of Medicine
Shiyan, Hubei, 442000
Wang Xianyu, M.D, 13972482018, wxytj@126.com
Li Shutao, M.D
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Yang Yali, M.S, 18703818071, yangyali_1982@163.com
About this study
Official title: Comparsion of the Effect of High Versus Low Mean Arterial Pressure (MAP) Levels on Clinical Outcomes in Elderly Patients During Noncardiothoracic Surgery Under General Anesthesia
This will be a multicentre, randomised, controlled and prospective clinical trial. All participants provided their written informed consent to participate in a randomized trial that examined the effects of low-level MAP (60-70 mmHg) vs. high-level MAP (90-100 mmHg) in elderly patients (65 or more years of age) during noncardiothoracic surgery under general anesthesia. The investigators hypothesise high-level blood presure of the intervention for reducing the incidence of post-operative complications.
Read the detailed description
This will be a multicentre, randomised, controlled and prospective clinical trial. Elderly patients will be included from seven centers, including Shenzhen People's Hospital affiliated to Jinan University, West China Hospital affiliated to Sichuan University, Taihe Hospital affiliated to Hubei University of Medicine, The Third Affiliated Hospital of Kunming Medical University, Sichuan Provincial People's Hospital, Guizhou Provincial People's Hospital and Henan Provincial People's Hospital. This research protocol was approved by the Institutional Review Board of Jinan University (2016001).
On the day of surgery, patients come to the operating room and are provided with standard monitoring. General anesthesia is given using midazolam and propofol, opioids, muscle relaxants and maintained with sevoflurane with inhaled concentrations of 1.5% sevoflurane in oxygen. Supplemental dosing of 1 μg/kg of fentanyl is used every hour from induction up to approximately 1 hour prior to the end of surgery. A tramadol bolus of 2 mg/kg is given 15 to 30 mins before the end of surgery. Propofol infusion is stopped 5 to 10 mins prior to the end of surgery, whereas at the end of skin closure, remifentanil was discontinued.
According to grouping, MAP is regulated to the goal level (60-70 mmHg or 95-100 mmHg) during general anesthesia. If necessary, intravenous antihypertensives (urapidil or phenylephrine when mean arterial pressure exceeded 10 mmHg of the target value), rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia. Atropine and esmolol would be used at the time of heart rate <50 beats/min and >110 beats/min, respectively.
Lactated Ringer's solution was given to bring the maintenance fluids to 10 ml/kg/h. Blood loss could be corrected for in a 1:1 ratio using gelofusine. Hospital transfusion guidelines were used to determine whether blood products were necessary (haemoglobin level less than 10 g/dl in patients with cardiac comorbidities, and below 7 g.dl-1 in those without cardiac disease). For later starting cases, an additional bolus of Ringer's solution of 1.5 ml/kg/fasted hour from 8 AM was given to bring the total 2 ml/kg/fasted hour. If urine output decreased to <0.5 mL/kg/h for 1 hour, fursemide 0.3 mg/kg was given.
Mechanical ventilation patterns are adjusted to obtain an end-tidal carbon dioxide value of 35-45 mmHg, at 5-10 min after induction of anesthesia.
For patients with endotracheal tubes, intravenous sedatives including propofol or midazolam were administrated continuously and titrated by bedside nurses to a target sedation level. Daily awakening is used for those who were not extubated in the morning.
All patients receive patient controlled intravenous analgesia during postoperative days 1 to 3.
- Conditions
- Aging, Surgery, Blood Pressure, Anesthesia, Blood Loss, Surgical, Postoperative Delirium
- Being tested
- Urapidil, Phenylephrine, Low-level MAP, High-level MAP
- Keywords
- MAP, Blood loss, Postoperative delirium, Elderly patients, Noncardiothoracic surgery
- Medical subject headings
- Blood Loss, Surgical, Emergence Delirium, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrapidilDrug
Also called Ebrantil
If necessary, intravenous urapidil 0.2-0.5 mg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.
PhenylephrineDrug
Also called Metaoxedrin, Neosynephrine
If necessary, intravenous phenylephrine 4-6 μg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.
Low-level MAPProcedure or surgery
MAP is regulated to the goal level (60-70 mmHg) during general anesthesia.
High-level MAPProcedure or surgery
MAP is regulated to the goal level (90-100 mmHg) during general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Low-level MAP | Experimental | According to grouping, MAP is regulated to the goal level (60-70 mmHg) during general anesthesia. Receives: Drug: Urapidil; Drug: Phenylephrine; Procedure: Low-level MAP |
| High-level MAP | Experimental | According to grouping, MAP is regulated to the goal level (90-100 mmHg) during general anesthesia. Receives: Drug: Urapidil; Drug: Phenylephrine; Procedure: High-level MAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
Measured: Within the first 7 days after surgery
Secondary outcomes (4)
Delirium duration days (Postoperative delirium defined by the confusion assessment method for the ICU (CAM-ICU))
Measured: Within the first 7 days after surgery
Intra-operative blood loss
Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.
Measured: Intra-operative
Intraoperative urine volume.
Measured: Intra-operative
All-cause 28-day mortality.
Outcome assessment will be performed by independent researchers.
Measured: The investigators would observe it within the 28-day period after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hu Anmin
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, The Affiliated Hospital Of Guizhou Medical University, Taihe Hospital, The Third Affiliated Hospital of Kunming Medical College., Sichuan Provincial People's Hospital, Henan Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Hu Anmin, The Second Clinical Medical College of Jinan University
- Investigators
- Hu Anmin, Study director, Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857153
- Sponsor's protocol ID
- 2016001
- Status last verified
- Aug 2016
- First submitted
- 15 Jul 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
London MJ. Intraoperative Mean Blood Pressure and Outcome: Is 80 (mmHg) the "New" 60? Anesthesiology. 2016 Jan;124(1):4-6. doi: 10.1097/ALN.0000000000000923. No abstract available.
PubMed 26540150Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.
PubMed 26083768Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589Chang HS, Hongo K, Nakagawa H. Adverse effects of limited hypotensive anesthesia on the outcome of patients with subarachnoid hemorrhage. J Neurosurg. 2000 Jun;92(6):971-5. doi: 10.3171/jns.2000.92.6.0971.
PubMed 10839257Reich DL, Bennett-Guerrero E, Bodian CA, Hossain S, Winfree W, Krol M. Intraoperative tachycardia and hypertension are independently associated with adverse outcome in noncardiac surgery of long duration. Anesth Analg. 2002 Aug;95(2):273-7, table of contents. doi: 10.1097/00000539-200208000-00003.
PubMed 12145033Hu A, Qiu Y, Zhang P, Hu B, Yang Y, Li S, Zhao R, Zhang Z, Zhang Y, Zheng Z, Qiu C, Li F, Gong X. Comparison of the effect of high versus low mean arterial pressure levels on clinical outcomes and complications in elderly patients during non-cardiothoracic surgery under general anesthesia: study protocol for a randomized controlled trial. Trials. 2017 Nov 21;18(1):554. doi: 10.1186/s13063-017-2233-8.
PubMed 29162132
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparsion of the Effect of High Versus Low Mean Arterial Pressure (MAP) Levels on Clinical Outcomes in Elderly Patients During Noncardiothoracic Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT02857153
- Acronym / sponsor ID
- 2016001
- Conditions
- Aging, Surgery, Blood Pressure, Anesthesia, Blood Loss, Surgical, Postoperative Delirium
- Keywords
- MAP, Blood loss, Postoperative delirium, Elderly patients, Noncardiothoracic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Hu AnminUniversity, hospital or other
- Collaborators
- West China Hospital, The Affiliated Hospital Of Guizhou Medical University, Taihe Hospital, The Third Affiliated Hospital of Kunming Medical College., Sichuan Provincial People's Hospital, Henan Provincial People's Hospital
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 5 Aug 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.
This will be a multicentre, randomised, controlled and prospective clinical trial. All participants provided their written informed consent to participate in a randomized trial that examined the effects of low-level MAP (60-70 mmHg) vs. high-level MAP (90-100 mmHg) in elderly patients (65 or more years of age) during noncardiothoracic surgery under general anesthesia. The investigators hypothesise high-level blood presure of the intervention for reducing the incidence of post-operative complications.
Detailed description
This will be a multicentre, randomised, controlled and prospective clinical trial. Elderly patients will be included from seven centers, including Shenzhen People's Hospital affiliated to Jinan University, West China Hospital affiliated to Sichuan University, Taihe Hospital affiliated to Hubei University of Medicine, The Third Affiliated Hospital of Kunming Medical University, Sichuan Provincial People's Hospital, Guizhou Provincial People's Hospital and Henan Provincial People's Hospital. This research protocol was approved by the Institutional Review Board of Jinan University (2016001).
On the day of surgery, patients come to the operating room and are provided with standard monitoring. General anesthesia is given using midazolam and propofol, opioids, muscle relaxants and maintained with sevoflurane with inhaled concentrations of 1.5% sevoflurane in oxygen. Supplemental dosing of 1 μg/kg of fentanyl is used every hour from induction up to approximately 1 hour prior to the end of surgery. A tramadol bolus of 2 mg/kg is given 15 to 30 mins before the end of surgery. Propofol infusion is stopped 5 to 10 mins prior to the end of surgery, whereas at the end of skin closure, remifentanil was discontinued.
According to grouping, MAP is regulated to the goal level (60-70 mmHg or 95-100 mmHg) during general anesthesia. If necessary, intravenous antihypertensives (urapidil or phenylephrine when mean arterial pressure exceeded 10 mmHg of the target value), rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia. Atropine and esmolol would be used at the time of heart rate <50 beats/min and >110 beats/min, respectively.
Lactated Ringer's solution was given to bring the maintenance fluids to 10 ml/kg/h. Blood loss could be corrected for in a 1:1 ratio using gelofusine. Hospital transfusion guidelines were used to determine whether blood products were necessary (haemoglobin level less than 10 g/dl in patients with cardiac comorbidities, and below 7 g.dl-1 in those without cardiac disease). For later starting cases, an additional bolus of Ringer's solution of 1.5 ml/kg/fasted hour from 8 AM was given to bring the total 2 ml/kg/fasted hour. If urine output decreased to <0.5 mL/kg/h for 1 hour, fursemide 0.3 mg/kg was given.
Mechanical ventilation patterns are adjusted to obtain an end-tidal carbon dioxide value of 35-45 mmHg, at 5-10 min after induction of anesthesia.
For patients with endotracheal tubes, intravenous sedatives including propofol or midazolam were administrated continuously and titrated by bedside nurses to a target sedation level. Daily awakening is used for those who were not extubated in the morning.
All patients receive patient controlled intravenous analgesia during postoperative days 1 to 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-level MAP | Experimental | Drug: Urapidil, Drug: Phenylephrine, Procedure: Low-level MAPAccording to grouping, MAP is regulated to the goal level (60-70 mmHg) during general anesthesia. |
| High-level MAP | Experimental | Drug: Urapidil, Drug: Phenylephrine, Procedure: High-level MAPAccording to grouping, MAP is regulated to the goal level (90-100 mmHg) during general anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- male and females, American Society of Anesthesiologists I-II-III, 65 or more years of age, scheduled to undergo noncardiothoracic surgery with general anesthesia are enrolled.
Key exclusion criteria (7 listed)
- the patient suffered from Cardiovascular Disease and Metabolic Diseases, such as hypertension, cardiac disease, diabetes;
- the patient has severe liver, kidney or blood disease;
- the patient is accompanied severe cognitive impairment (Mini-Mental State Examination (MMSE) score < 15);
- preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, or levodopa treatment;
- use of haloperidol or other neuroleptics during or after anesthesia;
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 |
|---|---|---|
| UrapidilAlso: EbrantilIf necessary, intravenous urapidil 0.2-0.5 mg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia. | Drug | High-level MAP, Low-level MAP |
| PhenylephrineAlso: Metaoxedrin, NeosynephrineIf necessary, intravenous phenylephrine 4-6 μg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia. | Drug | High-level MAP, Low-level MAP |
| Low-level MAPMAP is regulated to the goal level (60-70 mmHg) during general anesthesia. | Procedure or surgery | Low-level MAP |
| High-level MAPMAP is regulated to the goal level (90-100 mmHg) during general anesthesia. | Procedure or surgery | High-level MAP |
Primary outcome
Incidence of delirium
Time frame: Within the first 7 days after surgery
4 secondary outcomes
Delirium duration days (Postoperative delirium defined by the confusion assessment method for the ICU (CAM-ICU))
Time frame: Within the first 7 days after surgery
Intra-operative blood loss
Time frame: Intra-operative
Intraoperative urine volume.
Time frame: Intra-operative
All-cause 28-day mortality.
Time frame: The investigators would observe it within the 28-day period after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Background: PubMed 26540150London MJ. Intraoperative Mean Blood Pressure and Outcome: Is 80 (mmHg) the "New" 60? Anesthesiology. 2016 Jan;124(1):4-6. doi: 10.1097/ALN.0000000000000923. No abstract available.
- Results publication: PubMed 26083768Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.
- Results publication: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
- Results publication: PubMed 10839257Chang HS, Hongo K, Nakagawa H. Adverse effects of limited hypotensive anesthesia on the outcome of patients with subarachnoid hemorrhage. J Neurosurg. 2000 Jun;92(6):971-5. doi: 10.3171/jns.2000.92.6.0971.
- Results publication: PubMed 12145033Reich DL, Bennett-Guerrero E, Bodian CA, Hossain S, Winfree W, Krol M. Intraoperative tachycardia and hypertension are independently associated with adverse outcome in noncardiac surgery of long duration. Anesth Analg. 2002 Aug;95(2):273-7, table of contents. doi: 10.1097/00000539-200208000-00003.
- Derived from this study: PubMed 29162132Hu A, Qiu Y, Zhang P, Hu B, Yang Y, Li S, Zhao R, Zhang Z, Zhang Y, Zheng Z, Qiu C, Li F, Gong X. Comparison of the effect of high versus low mean arterial pressure levels on clinical outcomes and complications in elderly patients during non-cardiothoracic surgery under general anesthesia: study protocol for a randomized controlled trial. Trials. 2017 Nov 21;18(1):554. doi: 10.1186/s13063-017-2233-8.
- Individual participant dataSharing planned: Undecided
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
Hu Anmin study director
Jinan University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urapidil, Phenylephrine and Low-level MAP in people with Aging and Surgery, run by Hu Anmin at 7 sites 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: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Anmin (18026980789, toanmin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: Within the first 7 days after surgery). 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 NCT02857153, which also lists 6 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 16 Aug 2016.