Effects of Thoracic Epidural Analgesia in Geriatric Patients Undergoing Open Heart Surgery

NCT04708080 | Completed

• 1 other identifier: 2020/182
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly patients have a higher incidence of morbidity and mortality due to the interaction of various factors such as decreased physiological reserves, concomitant comorbidities, multiple drug use, cognitive dysfunction, and frailty. Surgical stress, pain and associated lung complications are common problems in open heart surgeries that can affect morbidity and mortality. With a good postoperative pain control and improved respiratory mechanics, complications that may develop in patients can be significantly prevented, and the hospital cost can be reduced and the workforce loss of patients can be reduced by reducing the length of hospital stay in the intensive care unit. Thoracic epidural analgesia (TEA) is an anesthetic analgesia method that has positive effects on many organ systems as well as providing good pain control and is frequently used in open heart surgery. The aim of this study is to investigate the effects of TEA on postoperative respiratory mechanics in geriatric patients, based on analgesia levels, extubation times, length of stay in intensive care, arterial blood gases, morbidity and mortality.

Conditions

Epidural Analgesia; Mechanical Ventilation; Postoperative Complications; Analgesia

Keywords

thoracic epidural analgesia; Postoperative Complications; mortality; Mechanical Ventilation; open heart surgery

Outcome Measures

Primary Outcomes (6)

• the effect of thoracic epidural analgesia

  postoperative respiratory parameters

  up to 4 weeks

• the effect of thoracic epidural analgesia

  Patients' sedation and analgesia levels

  postoperative period 3 day

• the effect of thoracic epidural analgesia

  extubation times

  1 day

• the effect of thoracic epidural analgesia

  postoperative respiratory complications

  1 month

• the effect of thoracic epidural analgesia

  lengths of ICU and hospitality stay

  up to 4 weeks

• the effect of thoracic epidural analgesia

  mortality

  1 year

Study Arms (2)

Group E

patients who underwent thoracic epidural catheter for postoperative analgesia

Procedure: thoracic epidural analgesia

Group I

Patients who cannot be applied thoracic epidural catheter for postoperative analgesia

Interventions

thoracic epidural analgesia PROCEDURE

A thoracic epidural catheter is routinely placed in patients undergoing open heart surgery in our hospital, at least 1 hour before heparin administration during the operation. After standard monitoring (ECG, SpO2, NIBP) is applied to the patients in the operating room, sedoanalgesia is provided with 1-3mg of midazolam and 50-100mcg of fentanyl. Then, by providing sterilization conditions, an epidural catheter is inserted through the T5-T6 interval with Tuohy needle. After confirming the location of the epidural catheter, 25mg / 10ml bupivacaine is administered as a bolus and then 3ml / hour bupivacaine infusion is started from the solution prepared as 3mg / ml and continues until the 48th postoperative hour. On the postoperative 2nd day, the catheter is removed 10-12 hours after LMWH administration and 2-4 hours after UFH, as recommended by the guidelines, paying attention to the anticoagulant administration times applied to the patients.

Group E

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study was planned as a retrospective (retrospective) study involving patients aged 65 and over who underwent elective open heart surgery between January 1, 2008 and December 31, 2019.

You may qualify if:

• Elective patients undergoing open heart surgery

You may not qualify if:

• Emergency operations
• Patients whose data cannot be reached
• Patients younger than 65
• Patients whose records could not be accessed and who were excluded from the study group procedure in which they were included for any reason will not be included in the study.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications; Agnosia

Interventions

Tea

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 13, 2021
• Study Start: July 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 15, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

TU (1)