Hypertension and Controlled Hypotension in the Elderly

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

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Diagnostic test: hypertension

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 Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

1. Patients who underwent radical anesthesia for oral and maxillofacial malignant tumors in our hospital
2. ASA grade is Ⅰ-Ⅱ
3. Patient is older than 60 years

Exclusion Criteria:

1. The patient has mental and mental disorders (eg schizophrenia, Alzheimer's disease)
2. There was severe anemia before operation (Hb<80g/L)
3. Patients had cerebral vascular complications such as cerebral infarction and lacunar infarction before operation
4. Patients who do not cooperate with this trial
5. Long-term use of sedative drugs or analgesics

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhang Lei
• Investigators: Study Director: Lei Zhang, Doctor, Study Director

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2020
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): December 7, 2020

Study Registration Dates

• First Submitted: June 13, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 9, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Hypertension; Delirium; Hypotension
• Other Study ID Numbers: SH9H-2020-T21-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No