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 (Anticipated): 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

Participation Criteria

Eligibility Criteria

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

• 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. Elective non-cardiac surgery;
3. Patients with American Society of Anesthesiologists(ASA) grade I-III;
4. Patients will undergo general anesthesia by endotracheal tube;
5. Patients who are willing to participate in this research.

Exclusion Criteria:

1. Severe vascular disease;
2. Secondary hypertension;
3. Chronic kidney disease (CKD) stage 5;
4. Unable to measure upper extremity blood pressure accurately;
5. Dental or oral swallowing disorders or unable to eat independently;
6. Patients or their families refuse to participate in this research.

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

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 (Anticipated): October 7, 2022
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): May 30, 2024

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): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular 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