Medical Records Investigation of Whether Perioperative Dexmedetomidine Will Reduce the Duration of Mechanical Ventilation or Hospital Length of Stay in Patients Undergoing Minimally Invasive Cardiac Surgery

NCT05038111 | Completed FDA Drug

• 1 other identifier: 110006-F
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The concept of enhanced recovery after surgery (ERAS) is utilizing in multiple specialties widely. Early tracheal extubation is one of the components of ERAS that enhances postoperative recovery and reduces the length of stay in intensive care unit (ICU).Dexmedetomidine is a highly selective, shorter-acting α2-adrenergic receptor agonist that has both analgesic and sedativeeffects.It was associated with decreased mortality, time to extubation, and hospital length of stay in cardiac surgical patients according to previous studies.The purpose of this study was to investigate the effect of perioperative dexmedetomidine on patients undergoing minimally invasive cardiac surgery(MICS) who were early extubated after surgery.

Conditions

Mechanical Ventilation; Hospital Length of Stay; Minimally Invasive Cardiac Surgery

Keywords

mechanical ventilation; hospital length of stay; dexmedetomidine; Minimally Invasive Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• postoperative mechanical ventilation duration

  from the time the patient arrived at the ICU until extubation

  up to 1 week

• ICU and hospital length of stay

  through admission, up to 1 month

Secondary Outcomes (1)

• postoperative complications

  according to ICD 10 on medical record, daily to discharge, up to 1 month

Study Arms (2)

Dex

Dexmedetomidine infusion during the perioperative period

Drug: Dexmedetomidine

Non-Dex

Did not have dexmedetomidine infusion during the perioperative period

Interventions

Dexmedetomidine DRUG

perioperative dexmedetomidine infusion

Dex

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were eligible for inclusion if they had undergone minimal invasive off-pump coronary artery bypass graft (CABG), valvular surgery or combined procedures at Far Eastern Memorial Hospital, New Taipei City, Taiwan between January 1, 2020 and August 31, 2020. Additionally patients were included if they were aged 20 years or older and were excluded if it was emergency surgery, if they had postoperative mechanical ventilation more than 6 hours or if they were extubated in the operating room.

You may qualify if:

• Patients undergone minimal invasive off-pump coronary artery bypass graft (CABG), valvular surgery or combined procedures at Far Eastern Memorial Hospital, New Taipei City, Taiwan between January 1, 2020 and August 31, 2020.
• Age above 20 y/o

You may not qualify if:

• Emergency surgery
• Postoperative mechanical ventilation more than 6 hours
• Extubated in the operating room

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 22061, Taiwan

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tsung-Hua Yang, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 8, 2021
• Study Start: March 11, 2021
• Primary Completion: March 22, 2021
• Study Completion: March 25, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)