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

NCT ID: NCT04483765

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-11-30

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.

Detailed Description

During the aging process, many important changes occur in the cardiovascular system. In elderly patients undergoing surgery, systemic vascular resistance is generally high but accompanying dehydration is a very common condition. The hemodynamic status of these patients may be compromised during spinal anesthesia due to the decrease in both systemic vascular resistance (SVR) and cardiac preload. Intraoperative hypotension may develop after spinal anesthesia. Intraoperative hypotension can prolong hospital stay by causing serious complications, and it can significantly affect mortality rates. Predicting hypotension which may develop after spinal anesthesia, can save time to decide, prepare and apply preventive interventions.

Shock index (SI) has been defined as the ratio of heart rate (HR) to systolic blood pressure (SBP). SI is an easy and non-invasive marker used in hypovolemia and early diagnosis of shock. SI is usually <0.7. In case of acute hypovolemia and circulatory failure, this ratio increases. It has been stated that in critical patients, diastolic blood pressure (DBP) will drop earlier than SBP, and the mean blood pressure will be a more accurate marker to assess the severity of the disease. For this reason, the modified shock index (MSI), which is obtained by dividing the heart rate by the mean arterial pressure (MAP), has been defined. MSI> 1.3 indicates a hypodynamic state.

The Age Shock Index (ASI) is defined by multiplying SI by age. In trauma patients, this index has been shown to correlate with a higher mortality rate with an increase greater than 50. Since age affects the physiological reserve negatively, it has been stated that ASI is a better predictor of 48-hour mortality compared to heart rate, SBP or SI. In studies evaluating ASI, SI and MSI to predict post-intubation hypotension; pre-intubation SI, MSI, ASI values have been shown to be the independent predictors of post-intubation hypotension.

Aim of this prospective observational study is to investigate whether SI, MSI and 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.

The secondary objective is to compare the two groups in terms of preoperative and postoperative blood tests, and to determine whether the patients were admitted to intensive care or postanesthesia care unit. If the patient was admitted, length of unit and hospital stay and postoperative complications (if developed any) will be recorded. In addition, the investigators will examine whether intraoperative hypotension has any negative effects.

Conditions

Anesthesia Morbidity; Procedural Hypotension; Intraoperative Hypotension; Geriatrics

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

spinal anesthesia

Intervention Type: PROCEDURE

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

post-spinal normotension

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

spinal anesthesia

Intervention Type: PROCEDURE

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

Interventions

spinal anesthesia

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ≥65 years old

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

ismail aytaç

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İsmail Aytac

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Anesthesiology Department

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

İsmail Aytac

Role: CONTACT

aytacismail1972@gmail.com

05056340369

Facility Contacts

İsmail Aytac

Role: primary

aytacismail1972@gmail.com

+905056340369

Other Identifiers

E1-20-787

Identifier Type: -

Identifier Source: org_study_id