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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05575661
Enrollment
120
Registered
2022-10-12
Start date
2022-11-07
Completion date
2025-09-30
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-induction Hypotension, Postprandial Hypotension

Brief summary

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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Elderly patients (≥ 65 years old); 2. Patients with American Society of Anesthesiologists(ASA) grade I-III; 3. Patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour; 4. Patients with intra-tracheal intubation following intravenous general ;anesthesia induction and maintenance;

Exclusion criteria

1. Patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, Buerger's disease, and Raynaud's syndrome 2. Patients with secondary hypertension, including renal hypertension and endocrine hypertension. 3. Patients with chronic kidney disease requiring dietary restrictions or dialysis. 4. Patients with Parkinson's disease or other conditions causing tremors. 5. Patients with problems related to oral food ingestion or those requiring enteral nutrition. 6. Patients with difficulties in measuring the upper extremities or communication problems that would interfere with study procedures. 7. Patients unable to remain in a supine position for at least 2 hours.

Design outcomes

Primary

MeasureTime frameDescription
Post-induction hypotensionWithin 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

MeasureTime frameDescription
Postoperative complicationsWithin 30 days after surgeryWe will use the Clavien-Dindo system to grade postoperative complications.
early intraoperative hypotension (eIOH)within the first 30 minutes after the start of surgerywhich is defined asa systolic blood pressure \<90 mmHg, mean arterial pressure \<65 mmHg, or a decrease of more than 30% from baseline
mortality within 30 days after surgerywithin 30 days after surgerywe will assess the mortality by postoperative follow-up
12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score)within 180 days after surgeryThe 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.

Countries

China

Contacts

Primary ContactLi Xu, M.D.
pumchxuli@163.com8610-69156114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026