QT Changes in Geriatric Patients: a Comparison of Spinal and General Anesthesia

NCT06375863 | Completed

• 1 other identifier: 44-2023
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

QT interval, defined as the time between the beginning of the QRS complex and the end of the T wave in electrocardiography (ECG), is an indicator of depolarization and repolarization of the myocardium.11 Prolongation of the heart rate corrected QT (QTc) interval reflects electrical instability of ventricles and is associated with life-threatening ventricular arrhythmias, including torsade de pointes, ventricular fibrillation and sudden cardiac death. Spinal anesthesia can cause profound prolongation of the QTc interval due to disparity between lumbar and thoracic sympathetic activity following subarachnoid block. Meanwhile inhalational anesthetics, sevoflurane, isoflurane, and desflurane are known to prolong QTc interval and intravenous anesthetics such as propofol, thiopental, etomidate and ketamin can also cause remarkable prolongation of the QTc interval. Moreover laryngoscopy and intubation may contribute to prolongation of the QTc interval because of the sympathetic stimulation. Over the years it has been occurred an increase in the proportion of elderly population requiring surgical anesthesia. The incidence of ventricular arrhythmias increases in advancing age even in the absence of underlying heart disease and elderly patients have reduced physiological functions and poor tolerance to anesthesia. However the choice of anesthesia type is critical in this population. To the best of knowledge, there was no published study to compare spinal anesthesia and inhalational anesthesia in elderly patients with regard to the QT interval changes. Investigators aimed to investigate the effects of spinal anesthesia on QT, QTc intervals and to compare general anesthesia with sevofluran in elderly patients.

Conditions

Anesthesia, Spinal; Sevoflurane; Long QT Syndrome

Outcome Measures

Primary Outcomes (1)

• QTc interval

  QTc interval on ECG calculated with Bazzets formula

  before anesthesia induction or spinal anesthesia; 1, 5 and 10 minutes after endotrakeal intubation or spinal anesthesia; after extubation or surgery

Secondary Outcomes (1)

• QT

  before anesthesia induction or spinal anesthesia; 1, 5 and 10 minutes after endotrakeal intubation or spinal anesthesia; after extubation or surgery

Study Arms (2)

spinal anesthesia

OTHER

patients who scheduled lower abdominal or urological surgery under spinal anesthesia older than 65 years

Diagnostic Test: QT and QTc interval

general anesthesia

OTHER

patients who scheduled lower abdominal or urological surgery under general anesthesia older than 65 years

Diagnostic Test: QT and QTc interval

Interventions

QT and QTc interval DIAGNOSTIC_TEST

measuring of QT and QTc on ECG

general anesthesia; spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: older than 65 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who scheduled lower abdominal or extremity surgery and urological surgery older than 65 years were enrolled to the study.

You may not qualify if:

• any preoperative ECG abnormalities, QTc interval \> 440 ms, family history of long QT syndome, use of any medications known to affect the QTc interval, serum electrolyte abnormalities, any contraindications for spinal anesthesia (e.g. coagulation disorders), unstable angina pektoris, chronic obstructive pulmonary disease, hepatic or renal failure, American Society of Anesthesiologists (ASA) physical classification status \> III, pregnancy and obesity (BMI \> 30).

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Health Science University, Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Song JH, Yang C, Lee W, Kim H, Kim Y, Kim H. QTc interval prolongation due to spinal anesthesia in patients with and without diabetes: an observational study. BMC Anesthesiol. 2022 May 13;22(1):143. doi: 10.1186/s12871-022-01614-8.

  PMID: 35562669 BACKGROUND

MeSH Terms

Conditions

Long QT Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• sinan uzman, Assoc. Prof.

  Health Science University Haseki Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate prof

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 19, 2024
• Study Start: March 29, 2023
• Primary Completion: May 29, 2023
• Study Completion: May 29, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to drsinanuzman@yahoo.com

Locations

TU (1)