Research on key technologies for perioperative risk management and control of age-related diseases
| ISRCTN | ISRCTN18251692 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18251692 |
- Submission date
- 20/04/2024
- Registration date
- 08/05/2024
- Last edited
- 10/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This project focuses on perioperative blood pressure management of elderly hypertensive patients and forms a management model of preoperative multidisciplinary evaluation and intervention. The project develops a mean arterial pressure (MAP)-guided blood pressure management program, explores the perioperative MAP management threshold of elderly hypertensive patients that can improve the prognosis of surgical patients, and studies the inflammatory mechanism of perioperative target organ injury in elderly hypertensive patients. To solve the bottleneck problem of perioperative clinical decision-making in elderly hypertension patients, the study will construct and promote key risk management technologies for elderly hypertension patients, and provide a basis and reference for the national development of the prevention and treatment system of elderly-related diseases and research on key technologies.
Who can participate?
Senior patients aged 65-80 years old who are planning to undergo general anesthesia and have a history of hypertension with systolic blood pressure ≥140mmHg and pulse pressure
What does the study involve?
In this study, the researchers will investigate how different approaches to managing blood pressure during surgery affect older individuals with hypertension. Elderly patients with hypertension who require surgery will be randomly assigned to one of three groups, each receiving a different method of blood pressure management during their operation. Brain activity and the function of the heart and kidneys will also be monitored throughout the surgical procedure. Following surgery, the researchers will conduct assessments on the day of the operation, as well as three days, one week, and one month post-surgery. These assessments will encompass factors such as blood pressure, pain levels, functional abilities, and any post-operative complications experienced. The objective is to determine the most effective blood pressure management strategy for elderly patients with hypertension, enabling healthcare professionals to tailor treatment plans accordingly. Additionally, the study will examine the impact of reduced opioid pain medication usage during surgery on gastrointestinal function and recovery outcomes in elderly hypertensive patients undergoing colorectal tumor surgery.
What are the possible benefits and risks of participating?
The shift towards intraoperative management strategies and targeted blood pressure regulation for perioperative hypertension patients promises significant benefits. Implementing precise blood pressure targets during surgery can markedly reduce the incidence of postoperative complications, enhancing patient outcomes and recovery. Additionally, this approach allows for a more targeted prevention and treatment of hypertension, offering valuable insights for intervention decisions even among non-hypertensive populations. Through the construction and promotion of key risk management technologies, particularly for elderly hypertension patients, the healthcare system can better address the unique needs of this demographic, ultimately improving the overall prevention and treatment of elderly-related diseases.
However, the adoption of stringent blood pressure regulation during surgery carries inherent risks, particularly in elderly hypertension patients. Hypotension, a common consequence of aggressive blood pressure control, poses significant dangers such as increasing the risk of ischemic cardiovascular and cerebrovascular events like acute myocardial infarction and cerebral thrombosis. Moreover, hypotension can lead to renal failure, syncope, shock, and fractures, and in the long term, chronic hypotension may even contribute to depression and senile dementia. Thus, while targeting blood pressure during surgery offers benefits, it necessitates careful monitoring and management to mitigate the risks associated with hypotension, especially in vulnerable patient populations.
Where is the study run from?
People's Hospital of Xinjiang Uygur Autonomous Region, China
When is the study starting and how long is it expected to run for?
February 2021 to May 2023
Who is funding the study?
Government of Xinjiang Uygur Autonomous Region of China
Who is the main contact?
Mrs Yankai Ma, 531571201@qq.com
Contact information
Public, Scientific, Principal Investigator
People's Hospital of Xinjiang Uygur Autonomous Region
Urumqi
830001
China
| Phone | +86 18799158127 |
|---|---|
| 531571201@qq.com |
Study information
| Study design | Single-center interventional single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Hospital, Medical and other records |
| Study type | Prevention, Screening, Treatment, Safety, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Research on key technologies for perioperative risk management in elderly patients |
| Study objectives | This project focuses on perioperative blood pressure management of elderly hypertensive patients, forms a management model of preoperative multidisciplinary evaluation and intervention, develops a mean arterial pressure (MAP)-guided blood pressure management program, explores the perioperative MAP management threshold of elderly hypertensive patients that can improve the prognosis of surgical patients, and studies the inflammatory mechanism of perioperative target organ injury in elderly hypertensive patients. To solve the bottleneck problem of perioperative clinical decision-making in elderly hypertension patients, construct and promote key risk management technologies for elderly hypertension patients, and provide a basis and reference for the national development of the prevention and treatment system of elderly-related diseases and research on key technologies. |
| Ethics approval(s) |
Approved 19/03/2021, Ethics Committee of People's Hospital of Xinjiang Uygur Autonomous Region (Xinjiang Uygur Autonomous Region People's Hospital, Xinjiang, Urumqi, 830001, China; +86 0991-8563857; quli1212@126.com), ref: KY2021031905 |
| Health condition(s) or problem(s) studied | Perioperative blood pressure management in elderly patients with hypertension |
| Intervention | In this study, the influence of mean arterial pressure (MAP)-guided perioperative blood pressure management mode on the outcome of elderly hypertensive patients will be explored. This experiment calculated MAP as follows: MAP = diastolic pressure +1/3 pulse pressure difference. Invasive arterial blood pressure monitoring will be performed in all patients under anesthesia, and the sensors will be placed at the same level to observe the blood pressure changes in real time. Elderly patients with hypertension who are planning to undergo general anesthesia will be randomly assigned to one of three groups, each implementing different levels of MAP management. The different levels will regulate MAP fluctuation ranges of 65-75 mmHg, 75-85 mmHg, and 85-95 mmHg during the operation, with multi-mode brain monitoring also in place. The method of randomisation uses a random number table method: Step 1: Generate random numbers: Use the "random number generator" of SPSS software to generate a random number with n x between 0 and 1, then define it as "random number" in "Transformation" - "Calculation variable" and set the numerical expression as "RV.UNIFORM (0,1)" to assign a random number to each patient for subsequent grouping. Step 2: Randomized grouping: random numbers are grouped using the "visual subdivision" in "Transformation", the variation of subdivision is set as "group", divided into two groups, and the number of segmentation points is set as 1 to obtain the variable "group". Patients in group 1 are included in group A, and patients in group 2 are included in group B to complete random grouping. Monitoring includes transcranial Doppler (TCD) for cerebral blood flow, regional oxygen saturation (rSO2) for cerebral metabolism, and bispectral index (BIS) for electroencephalogram (EEG), along with cardiac and renal function monitoring. Multidisciplinary assessments will be conducted on the day of surgery, as well as three days, one week, and one month after surgery. These assessments will cover various aspects such as blood pressure, pain score, functional status, cognitive function, speciality rehabilitation, surgical complications, the incidence of target organ injury (such as stroke, acute coronary syndrome, kidney injury), the average length of stay, ICU transfer rate, and postoperative outcomes. The aim is to determine the most suitable management threshold for perioperative MAP in elderly patients with hypertension, allowing for the formulation of individualized blood pressure management strategies for clinical diagnosis and treatment. Additionally, the study will examine the effects of low-opioid multimodal analgesia and anesthesia on intestinal function and prognosis in elderly hypertensive patients after colorectal tumor surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Blood pressure level measured using the cuff three times a day, three days, one week and one month after surgery 2. Pain measured using a Visual Analog Scale (VAS) on the day, three days and one week after surgery 3. Body function and cognition measured using the unified standard rating scale after the operation 4. Rehabilitation will be measured by Specialists to establish a unified standard of physical examination to judge the rehabilitation of patients after the operation 5. Surgical complications, incidence of target organ injury (stroke, acute coronary syndrome, kidney injury), average length of stay, ICU transfer rate, and postoperative outcomes measured using data collected in patient medical records on the day, three days, one week, and one month after surgery |
| Secondary outcome measures | 1. Perioperative stress indexes (blood glucose and cortisol) and inflammatory indexes (IL-6, TNF-α and C-reactive protein) measured using standard tests in venous blood samples before surgery, on the day after surgery, and on the second and third days after surgery, respectively, at 8 pm 2. Target organ function indicators (myocardial enzyme profile, urea nitrogen, creatinine, NSE and S100β) measured using standard tests in venous blood samples at 8 pm on the first day, three days and one week after surgery |
| Overall study start date | 01/02/2021 |
| Completion date | 02/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Total final enrolment | 1800 |
| Key inclusion criteria | 1. Elderly patients, aged 65-80 years old 2. Patients with a history of hypertension with systolic blood pressure ≥140mmHg and pulse pressure difference ≥60mmHg 3. No contraindications to anesthesia 4. No signs of systemic infection |
| Key exclusion criteria | 1. Tumors in other locations 2. A history of long-term use of sedative and analgesic drugs 3. Uncontrollable hypertension 4. Hyperglycemia 5. Severe liver and kidney dysfunction 6. Other contraindications for surgery |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 01/03/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Urumqi
830001
China
Sponsor information
Hospital/treatment centre
Xinjiang Anesthesia Management Clinical Medical Research Center, Xinjiang
Urumqi
830001
China
| Phone | +86 13565958371 |
|---|---|
| quli1212@126.com | |
| Website | http://www.xjrmyy.com/#/index |
"ROR" |
https://ror.org/02r247g67 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- 新疆维吾尔自治区人民政府, People's Government of Xinjiang Uygur Autonomous Region, Xinjiang Uygur Autonomous Region Government, The Government of Xinjiang Uygur Autonomous Region of China
- Location
- China
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/10/2024 | 10/06/2025 | Yes | No |
Editorial Notes
10/06/2025: Publication reference added.
29/04/2024: Study's existence confirmed by the Ethics Committee of People's Hospital of Xinjiang Uygur Autonomous Region.
