Hypertension and Controlled Hypotension in the Elderly

Completed

• Conditions: Delirium
• Interventions: Diagnostic Test: hypertension

• Registration Number: NCT04433416
• Lead Sponsor: Zhang Lei

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

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 Timeline

• Study First Submitted: 2020-06-13
• Study Start: 2020-06-14
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-16
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-09
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hypertension	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

Primary Outcome Measures

Name	Time	Method
Degree of delirium	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.

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China