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NCT Number: NCT05575661

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

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.

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Key information

Conditions

Postprandial Hypotension Post-Induction Hypotension

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Post-induction hypotension

    Time frame: Within 20 minutes after induction or before incision.

    which is defined as systolic blood pressure (SBP) <90 mm Hg or a decrease of more than 30% from baseline blood pressure, mean arterial pressure(MAP)<65 mm Hg or a decrease of more than 30% from baseline blood pressure within 20 minutes after induction or before incision.

Secondary outcomes

  1. Postoperative complications

    Time frame: Within 30 days after surgery

    We will use the Clavien-Dindo system to grade postoperative complications.

  2. early intraoperative hypotension （eIOH）

    Time frame: within the first 30 minutes after the start of surgery

    which is defined asa systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg, or a decrease of more than 30% from baseline

  3. mortality within 30 days after surgery

    Time frame: within 30 days after surgery

    we will assess the mortality by postoperative follow-up

  4. 12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score)

    Time frame: within 180 days after surgery

    The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) will be employed to evaluate postoperative functional health status. The 12-item version yields a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer health outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Xu, M.D.

CONTACT

[email protected]

8610-69156114

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2022
Registry last updated
May 15, 2025

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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