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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation; Hospital Length of Stay; Minimally Invasive Cardiac Surgery
• Intervention / Treatment: Drug: Dexmedetomidine

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 22061
    • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dex; Dexmedetomidine infusion during the perioperative period	Drug: Dexmedetomidine; perioperative dexmedetomidine infusion
Non-Dex; Did not have dexmedetomidine infusion during the perioperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	atrial fibrillation, bradyarrhythmia, myocardial infarction, cerebrovascular accident, acute renal failure and delirium	according to ICD 10 on medical record, daily to discharge, up to 1 month

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Tsung-Hua Yang, MD, Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): March 25, 2021

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: mechanical ventilation; dexmedetomidine; hospital length of stay; Minimally Invasive Cardiac Surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 110006-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes