Dexmedetomidine in Non-intubated VATS

Phase 4

Recruiting

• Conditions: Analgesia; Dexmedetomidine; Thoracoscopy
• Interventions: Drug: Dexmedetomidine infusion

• Registration Number: NCT05863416
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-18
• Status Verified: 2024-04
• Study Start: 2024-04-23
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Dexmedetomidine	Dexmedetomidine infusion	Propofol-based total intravenous anesthesia with dexmedetomidine infusion
Group Saline	Dexmedetomidine infusion	Propofol-based total intravenous anesthesia with saline infusion

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total fentanyl consumption	Intraoperative period	Total fentanyl requirement during surgery
Intraoperative fentanyl consumption	Intraoperative period	Fentanyl bolus for cough reflex and limb movement
Total propofol consumption	Intraoperative period	Total propofol requirement during surgery
Intraoperative adverse events	Intraoperative period	The incidence of hypotension, bradycardia and hypoxia
Postoperative opioid requirement	Postoperative 48 hours	Postoperative opioid requirement within postoperative 48 hours
Postoperative numeric rating scale	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.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan