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

NCT05575661 | Recruiting

• 1 other identifier: I-22PJ008
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Hypotension; Post-induction Hypotension

Outcome Measures

Primary Outcomes (1)

• Post-induction hypotension

  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.

  Within 20 minutes after induction or before incision.

Secondary Outcomes (4)

• Postoperative complications

  Within 30 days after surgery

• early intraoperative hypotension （eIOH）

  within the first 30 minutes after the start of surgery

• mortality within 30 days after surgery

  within 30 days after surgery

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

  within 180 days after surgery

Study Arms (2)

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 postprandial hypotension group

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients scheduled for elective non-cardiac surgery under general anesthesia in Peking Union Medical College Hospital

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Officials

• Li Xu, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xu, M.D.

CONTACT

8610-69156114; pumchxuli@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: November 7, 2022
• Primary Completion: July 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)