DeliriumNCT04433416
Hypertension and Controlled Hypotension in the Elderly
An observational study of Delirium, run by Zhang Lei at 1 site in China.
Trial summary
Comparision of Exposed Factors of Preoperative Hypertension and Intraoperative Controlled Hypotension on Postoperative Delirium in the Elderly under Radical Resection of Head, Neck and Maxillofacial Tumor Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- hypertension
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2020to 7 Dec 2020
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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
Study population: The subject was a patient undergoing radical surgery for general anesthesia for mandibular and facial malignant tumors. The patients who had just been admitted to the hospital were preoperatively visited 2-3 days before the operation. According to whether the patient had a history of hypertension and the blood pressure value in the calm state after three admissions, Patients were divided into hypertensive group and non-hypertensive group.
Who may be able to join
- Patients who underwent radical anesthesia for oral and maxillofacial malignant tumors in our hospital
- ASA grade is Ⅰ-Ⅱ
- Patient is older than 60 years
Who cannot join
- The patient has mental and mental disorders (eg schizophrenia, Alzheimer's disease)
- There was severe anemia before operation (Hb<80g/L)
- Patients had cerebral vascular complications such as cerebral infarction and lacunar infarction before operation
- Patients who do not cooperate with this trial
- Long-term use of sedative drugs or analgesics
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200001
About this study
Official title: Effect of Preoperative Hypertension and Controlled Hypotension on Postoperative Delirium in the Elderly
Comparision of Exposed Factors of Preoperative Hypertension and Intraoperative Controlled Hypotension on Postoperative Delirium in the Elderly under Radical Resection of Head, Neck and Maxillofacial Tumor
Read the detailed description
Postoperative delirium has a higher incidence in elderly patients after general anesthesia，and It is closely related to the type of surgery, the length of surgery, and the patient's physique.Because head and neck maxillofacial radical surgery requires free flap transplantation and longer duration,and hemorrhage is more when the primary focus is removed，Intraoperative blood pressure reduction is needed to reduce bleeding，therefore, hypoperfusion of craniocerebral blood flow will occur.Low cerebral perfusion is closely related to the occurrence of postoperative delirium.Patients undergoing this type of surgery have more preoperative complications，hypertension is particularly common.Therefore, this study mainly studied the correlation between the preoperative blood pressure level and the controlled hypotension level in patients with radical head and neck and maxillofacial tumors and the incidence of postoperative delirium.
- Conditions
- Delirium
- Being tested
- hypertension
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertensionDiagnostic test
If the patient has two or more blood pressure values ≥140/90mmHg in a calm state, he is included in this group
| Study group | Role | What they receive |
|---|---|---|
| hypertension | After admission, two or more of the three blood pressure measurements under the same period of calm state that met hypertension, and the patient reported that he had a history of hypertension and that the blood pressure reached the standard of hypertension in the previous non-medication state was included in the hypertension group Receives: Diagnostic Test: hypertension | |
| non-hypertension | Patients who denied the history of hypertension and were not taking antihypertensive drugs after admission and had normal blood pressure measurements were included in the non-hypertensive group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of delirium
From the first to the third day after surgery, the patient will be evaluated for delirium using the CAM scale.
Measured: up to three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start14 Jun 2020
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Zhang Lei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Lei, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Lei Zhang, Doctor, Study director, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433416
- Sponsor's protocol ID
- SH9H-2020-T21-3
- Status last verified
- Jan 2021
- First submitted
- 13 Jun 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Hypertension and Controlled Hypotension on Postoperative Delirium in the Elderly
- ClinicalTrials.gov ID
- NCT04433416
- Acronym / sponsor ID
- SH9H-2020-T21-3
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Zhang LeiUniversity, hospital or other
- Study start
- 14 Jun 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- 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.
Comparision of Exposed Factors of Preoperative Hypertension and Intraoperative Controlled Hypotension on Postoperative Delirium in the Elderly under Radical Resection of Head, Neck and Maxillofacial Tumor
Detailed description
Postoperative delirium has a higher incidence in elderly patients after general anesthesia，and It is closely related to the type of surgery, the length of surgery, and the patient's physique.Because head and neck maxillofacial radical surgery requires free flap transplantation and longer duration,and hemorrhage is more when the primary focus is removed，Intraoperative blood pressure reduction is needed to reduce bleeding，therefore, hypoperfusion of craniocerebral blood flow will occur.Low cerebral perfusion is closely related to the occurrence of postoperative delirium.Patients undergoing this type of surgery have more preoperative complications，hypertension is particularly common.Therefore, this study mainly studied the correlation between the preoperative blood pressure level and the controlled hypotension level in patients with radical head and neck and maxillofacial tumors and the incidence of postoperative delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertension | – | Diagnostic Test: hypertensionAfter admission, two or more of the three blood pressure measurements under the same period of calm state that met hypertension, and the patient reported that he had a history of hypertension and that the blood pressure reached the standard of hypertension in the previous non-medication state was included in the hypertension group |
| non-hypertension | – | –Patients who denied the history of hypertension and were not taking antihypertensive drugs after admission and had normal blood pressure measurements were included in the non-hypertensive group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject was a patient undergoing radical surgery for general anesthesia for mandibular and facial malignant tumors. The patients who had just been admitted to the hospital were preoperatively visited 2-3 days before the operation. According to whether the patient had a history of hypertension and the blood pressure value in the calm state after three admissions, Patients were divided into hypertensive group and non-hypertensive group.
Key inclusion criteria (3 listed)
- Patients who underwent radical anesthesia for oral and maxillofacial malignant tumors in our hospital
- ASA grade is Ⅰ-Ⅱ
- Patient is older than 60 years
Key exclusion criteria (5 listed)
- The patient has mental and mental disorders (eg schizophrenia, Alzheimer's disease)
- There was severe anemia before operation (Hb<80g/L)
- Patients had cerebral vascular complications such as cerebral infarction and lacunar infarction before operation
- Patients who do not cooperate with this trial
- Long-term use of sedative drugs or analgesics
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 |
|---|---|---|
| hypertensionIf the patient has two or more blood pressure values ≥140/90mmHg in a calm state, he is included in this group | Diagnostic test | hypertension |
Primary outcome
Degree of delirium
Time frame: up to three days after surgery
From the first to the third day after surgery, the patient will be evaluated for delirium using the CAM scale.
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 12 Jan 2021.
- 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.
Lei Zhang, Doctor study director
Study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Zhang Lei 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 5 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 12 Jan 2021. 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?
Degree of delirium (time frame: up to three days after surgery). 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 12 Jan 2021.