Correlation Between Perioperative Autonomic Function and Post-induction Hypotension in Elderly Patients

NCT05425147 | Recruiting

• 1 other identifier: PUMCHanesthesia-elderly
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly patients have a higher risk of post-induction hypotension (PIH). The decreased cardiovascular autonomic function at baseline in elderly patients may contribute to the development of PIH. The objective of our study is to effect of preoperative cardiovascular autonomic modulation in PIH, we will recruit elderly patients who are going to have general anesthesia surgery and measure preoperative baroreflex sensitivity (BRS) and heart rate variability (HRV). The primary outcome will be PIH. Secondary outcomes included: early intraoperative hypotension, postoperative complications, and 30-day postoperative mortality.

Conditions

Intraoperative Hypotension

Keywords

post-induction hypotension, autonomic function, elderly patients

Outcome Measures

Primary Outcomes (1)

• Post-induction hypotension

  Systolic blood pressure (SBP) \<90 mmHg, mean arterial pressure (MAP) \<65 mmHg, or a decrease of more than 30% of baseline

  within 20 minutes after induction or before incision

Secondary Outcomes (3)

• Early intraoperative hypotension

  within 30 minutes after incision

• postoperative complications

  30 days after the surgery

• mortality

  30 days after the surgery

Study Arms (2)

Post-induction hypotension group

Post-induction hypotension is defined as systolic blood pressure (SBP) \<90 mmHg, mean arterial pressure (MAP) \<65 mmHg, or a decrease of more than 30% of baseline within 20 minutes after induction or before incision.

Other: Perioperative autonomic function assessment

Stable blood pressure group

All enrolled elderly patients will undergo surgery under general anesthesia after preoperative monitoring. Those patients whose blood pressure is relatively stable after induction and does not meet the PIH criteria is classified as the stable blood pressure group.

Other: Perioperative autonomic function assessment

Interventions

Perioperative autonomic function assessment OTHER

Patients will have BRS and HRV measurements taken for approximately 20 minutes, one day before surgery and on the day of surgery. We use LiDCO rapid to conduct non-invasive pulse and beat-to-beat blood pressure monitoring.

Post-induction hypotension group; Stable blood pressure group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients who will undergo general anesthesia surgery in Peking Union Medical College Hospital.

You may qualify if:

• Age ≥ 65 years old;
• Elective non-cardiac surgery;
• ASA Class I-III;
• General anesthesia;
• Use a tracheal tube as an airway management tool;
• Patients and their families can understand the research protocol and are willing to participate in this research

You may not qualify if:

• Severe vascular disease;
• Secondary hypertension;
• Parkinson's disease;
• Cannot measure upper extremity blood pressure for various reasons;
• Arrhythmias such as atrial fibrillation cannot perform HRV measurement;
• Mentally abnormal and unable to cooperate

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Related Publications (5)

• Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

  PMID: 8737210 BACKGROUND

• Padley JR, Ben-Menachem E. Low pre-operative heart rate variability and complexity are associated with hypotension after anesthesia induction in major abdominal surgery. J Clin Monit Comput. 2018 Apr;32(2):245-252. doi: 10.1007/s10877-017-0012-4. Epub 2017 Mar 14.

  PMID: 28293808 BACKGROUND

• Ziemssen T, Siepmann T. The Investigation of the Cardiovascular and Sudomotor Autonomic Nervous System-A Review. Front Neurol. 2019 Feb 12;10:53. doi: 10.3389/fneur.2019.00053. eCollection 2019.

  PMID: 30809183 BACKGROUND

• La Rovere MT, Pinna GD, Raczak G. Baroreflex sensitivity: measurement and clinical implications. Ann Noninvasive Electrocardiol. 2008 Apr;13(2):191-207. doi: 10.1111/j.1542-474X.2008.00219.x.

  PMID: 18426445 BACKGROUND

• Cui Q, Che L, Zang H, Yu J, Xu L, Huang Y. Association between preoperative autonomic nervous system function and post-induction hypotension in elderly patients: a protocol for a cohort study. BMJ Open. 2023 Jan 30;13(1):e067400. doi: 10.1136/bmjopen-2022-067400.

  PMID: 36717143 DERIVED

Study Design

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

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: July 25, 2022
• Primary Completion: January 11, 2025
• Study Completion: March 1, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)