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NCT Number: NCT04433416

Hypertension and Controlled Hypotension 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

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Degree of delirium

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhang Lei

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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