Shock Index, Modified Shock Index and Age-related Shock Index for Predicting Post-spinal Hypotension in Elderly Patients

NCT04483765 | Unknown

• 1 other identifier: E1-20-787
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this prospective observational study is to investigate whether shock index(SI), modified shock index(MSI) and age related shock index(ASI) have any predictive value in predicting post-spinal hypotension which may develop in patients over 65 years of age, who are planned to undergo transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

Conditions

Anesthesia Morbidity; Procedural Hypotension; Intraoperative Hypotension; Geriatrics

Keywords

geriatric anesthesia; post-spinal hypotension; Intraoperative Hypotension; spinal anesthesia; shock index; modified shock index; age-related shock index

Outcome Measures

Primary Outcomes (3)

• SI

  shock index: defined as the ratio of heart rate (HR) to systolic blood pressure (SBP)

  preoperative

• MSI

  Modified Shock İndex: obtained by dividing the heart rate by the mean arterial pressure

  preoperative

• ASI

  Age Shock Index (ASI) is defined by multiplying shock index(SI) by age

  preoperative

Secondary Outcomes (2)

• CCI

  preoperative

• length of hospital stay

  through study completion, an average of 3 months

Study Arms (2)

post-spinal hypotension

Patients with a fall in SBP by 25% of the preoperative baseline or an absolute value \<90 mm of Hg; MAP ≤65 mmHg after spinal anesthesia

Procedure: spinal anesthesia

post-spinal normotension

Patients with Fall of SBP\<%25 of the preoperative value or absolute value \>90 mm Hg, MAP\>65 mmHg

Procedure: spinal anesthesia

Interventions

spinal anesthesia PROCEDURE

patients undergoing transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

post-spinal hypotension; post-spinal normotension

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Paients undergo transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

You may qualify if:

• ≥65 years old

You may not qualify if:

• duration of operation\>120 minutes ASA\>3
• Patients with valvular heart disease that disrupts hemodynamics
• Patients with arrhythmia (such as atrial fibrillation with rapid ventricular rate) that disrupts hemodynamics
• severe heart failure
• mental and motor problems
• neuropsychiatric disorders

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• İsmail Aytac

  Ankara City Hospital Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İsmail Aytac

CONTACT

05056340369; aytacismail1972@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: July 23, 2020
• Study Start: July 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)