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.

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.

Study Overview

• Status: Recruiting
• Conditions: Post-induction Hypotension; Postprandial Hypotension

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Li Xu, M.D.; Phone Number: 8610-69156114; Email: pumchxuli@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Han Zang, Master; Phone Number: 8610-69156114; Email: zanghan1221@163.com
      • Contact: Tianchun Li, Master; Phone Number: 8610-69156114; Email: s2023001152@pumc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	We will use the Clavien-Dindo system to grade postoperative complications.	Within 30 days after surgery
early intraoperative hypotension （eIOH）	which is defined asa systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg, or a decrease of more than 30% from baseline	within the first 30 minutes after the start of surgery
mortality within 30 days after surgery	we will assess the mortality by postoperative follow-up	within 30 days after surgery
12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score)	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.	within 180 days after surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Li Xu, M.D., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: I-22PJ008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No