Hypertension and Controlled Hypotension in the Elderly

Delirium Clinical Trial

Official title:

Effect of Preoperative Hypertension and Controlled Hypotension on Postoperative Delirium in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433416
• Other study ID #: SH9H-2020-T21-3
• Status: Completed
• Start date: June 14, 2020
• Est. completion date: December 7, 2020

Study information

• Verified date: January 2021
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Patients who underwent radical anesthesia for oral and maxillofacial malignant tumors in our hospital

2. ASA grade is ?-?

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

Related Conditions & MeSH terms

• Delirium
• Hypertension
• Hypotension

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Lei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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