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Recruiting NCT05575661

Correlation Between Postprandial Hypotension and Post-induction Hypotension in the Elderly.

Observational Postprandial Hypotension Post-induction Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Postprandial Hypotension, Post-induction Hypotension. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Correlation Between Postprandial Hypotension and Perioperative Adverse Events Such as Post-induction Hypotension in the Elderly: a Prospective Observational Study.

Overview

Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly.

Detailed description

With the deepening of the aging population in our country, the number of elderly patients undergoing surgery is also increasing. Elderly patients are at higher risk for hemodynamic instability due to organ dysfunction, decreased physiological reserve, and the coexistence of multiple chronic diseases.Postprandial hypotension (PPH) is common but often unrecognized among the elderly.PPH is defined as a fall in systolic blood pressure of \>20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of a meal.The pathophysiology of PPH is not clear, the decreased cardiovascular autonomic function may play an important role. Post-induction hypotension (PIH) occurs after induction but before surgical incision and autonomic dysfunction is regarded as one of the major mechanisms.This study aims to prospectively explore the correlation between PPH and perioperative adverse events such as PIH in the elderly.

Primary outcome measures

  • Post-induction hypotension [Time frame: Within 20 minutes after induction or before incision.]
Secondary outcome measures (4)
  • Postoperative complications [Time frame: Within 30 days after surgery]
  • early intraoperative hypotension (eIOH) [Time frame: within the first 30 minutes after the start of surgery]
  • mortality within 30 days after surgery [Time frame: within 30 days after surgery]
  • 12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score) [Time frame: within 180 days after surgery]

Eligibility criteria

Inclusion criteria

  • Elderly patients (≥ 65 years old);
  • Patients with American Society of Anesthesiologists(ASA) grade I-III;
  • Patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour;
  • Patients with intra-tracheal intubation following intravenous general ;anesthesia induction and maintenance;

Exclusion criteria

  • Patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, Buerger's disease, and Raynaud's syndrome
  • Patients with secondary hypertension, including renal hypertension and endocrine hypertension.
  • Patients with chronic kidney disease requiring dietary restrictions or dialysis.
  • Patients with Parkinson's disease or other conditions causing tremors.
  • Patients with problems related to oral food ingestion or those requiring enteral nutrition.
  • Patients with difficulties in measuring the upper extremities or communication problems that would interfere with study procedures.
  • Patients unable to remain in a supine position for at least 2 hours.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Publications

  • Li T, Zang H, Che L, Cui Q, Xu L. Correlation between postprandial hypotension and post-induction hypotension in the elderly: a protocol for a prospective cohort study. BMJ Open. 2025 May 30;15(5):e095466. doi: 10.1136/bmjopen-2024-095466. PMID 40447437

Identifiers

NCT: NCT05575661 · I-22PJ008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗