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

NCT ID: NCT05575661

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-07

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Postprandial Hypotension Post-induction Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Postprandial hypotension group

Patients who have 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 the lunch

No interventions assigned to this group

No postprandial hypotension group

Patients who do not meet the postprandial hypotension criteria within 2 hours of the lunch

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Xu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Xu, M.D.

Role: CONTACT

8610-69156114

Facility Contacts

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Han Zang, Master

Role: primary

8610-69156114

Tianchun Li, Master

Role: backup

8610-69156114

References

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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.

Reference Type DERIVED
PMID: 40447437 (View on PubMed)

Other Identifiers

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I-22PJ008

Identifier Type: -

Identifier Source: org_study_id

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