Clinical trial NCT04433416: Hypertension and Controlled Hypotension in the Elderly
Official title: Effect of Preoperative Hypertension and Controlled Hypotension on Postoperative Delirium in the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 98
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of delirium
timeFrame: up to three days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Study director
name: Lei Zhang, Doctor
role: STUDY_DIRECTOR
References: