Hypertension and Controlled Hypotension in the Elderly

NCT04433416 | Completed

• 1 other identifier: SH9H-2020-T21-3
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Degree of delirium

  From the first to the third day after surgery, the patient will be evaluated for delirium using the CAM scale.

  up to three days after surgery

Study Arms (2)

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

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

Interventions

hypertension DIAGNOSTIC_TEST

If the patient has two or more blood pressure values ≥140/90mmHg in a calm state, he is included in this group

hypertension

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhang Lei: lead

Study Sites (1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

Delirium

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lei Zhang, Doctor

  Study director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician and Associate Researcher

Study Record Dates

• First Submitted: June 13, 2020
• First Posted: June 16, 2020
• Study Start: June 14, 2020
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)