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Completed

NCT Number: NCT05863416

Dexmedetomidine in Non-intubated VATS

This prospective study aims to evaluate the effectiveness of intraoperative DEX for postoperative analgesia and recovery after non-intubated VATS. In addition, the investigators observe the impact of DEX on anesthetic requirements, hemodynamic parameters, and adverse events during non-intubated VATS.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tri-Service General Hospital

Taipei, 114, Taiwan

About this study

The non-intubated thoracoscopic approach has been adapted for use with major lung resections. The non-intubated VATS tries to minimize the adverse effects of tracheal intubation and general anesthesia, such as intubation-related airway trauma, ventilation-induced lung injury, residual neuromuscular blockade, and postoperative nausea and vomiting. An adequate analgesia allows VATS to be performed in sedated patients and the potential adverse effects related to general anesthesia and selective ventilation can be avoided. Dexmedetomidine (DEX), a highly selective alpha-2 receptor agonist, is increasingly used in anesthesia with sedative, hypnotic, anxiolytic, sympatholytic, and analgesic effects. It can also attenuate perioperative stress and inflammation and preserve the immunity of surgical patients, which may contribute to reduced postoperative complications and improved clinical outcomes. This study aims to evaluate the effectiveness of intraoperative DEX for postoperative analgesia and recovery after non-intubated VATS. In addition, the investigators observe the impact of DEX on anesthetic requirements, hemodynamic parameters, and adverse events during non-intubated VATS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) score of I-III patients receiving video-assisted thoracoscopic surgery

Exclusion criteria

  • Age < 18 or > 80 years
  • ASA classifications > III
  • Pregnancy
  • Known allergies to any drugs used in the study
  • Emergency surgery
  • Patient refusal
  • Chronic pain history

Treatment and study plan

Dexmedetomidine infusion

Drug

Intraoperative dexmedetomidine infusion

Primary outcomes

  1. Cough

    Time frame: Intraoperative period

    The incidence of cough reflex during surgery and severity Cough severity: 1=none, 2=slight, 3=moderate, 4=severe

Secondary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: Intraoperative period

    Fentanyl bolus for cough reflex and limb movement

  2. Total fentanyl consumption

    Time frame: Intraoperative period

    Total fentanyl requirement during surgery

  3. Total propofol consumption

    Time frame: Intraoperative period

    Total propofol requirement during surgery

  4. Intraoperative adverse events

    Time frame: Intraoperative period

    The incidence of hypotension, bradycardia and hypoxia

  5. Postoperative numeric rating scale

    Time frame: Postoperative 48 hours

    Numeric rating scale within postoperative 48 hours NRS scores is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.

  6. Postoperative opioid requirement

    Time frame: Postoperative 48 hours

    Postoperative opioid requirement within postoperative 48 hours

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

Adjunctive Dexmedetomidine Infusion in Non-intubated Video-assisted Thoracoscopic Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 18, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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