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Dexmedetomidine in Non-intubated VATS

Sponsor
Tri-Service General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05863416
Collaborator
(none)
144
Enrollment
2
Arms
23
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmedetomidine infusion
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Adjunctive Dexmedetomidine Infusion in Non-intubated Video-assisted Thoracoscopic Surgery
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group Saline

Propofol-based total intravenous anesthesia with saline infusion

Drug: Dexmedetomidine infusion
Intraoperative dexmedetomidine infusion
Experimental: Group Dexmedetomidine

Propofol-based total intravenous anesthesia with dexmedetomidine infusion

Drug: Dexmedetomidine infusion
Intraoperative dexmedetomidine infusion

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Intraoperative fentanyl consumption [Intraoperative period]

    Fentanyl bolus for cough reflex and limb movement

  2. Total fentanyl consumption [Intraoperative period]

    Total fentanyl requirement during surgery

  3. Total propofol consumption [Intraoperative period]

    Total propofol requirement during surgery

  4. Intraoperative adverse events [Intraoperative period]

    The incidence of hypotension, bradycardia and hypoxia

  5. 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.

  6. Postoperative opioid requirement [Postoperative 48 hours]

    Postoperative opioid requirement within postoperative 48 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tri-Service General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wei-Cheng Tseng, Principal Investigator, Tri-Service General Hospital
ClinicalTrials.gov Identifier:
NCT05863416
Other Study ID Numbers:
  • B202305049_V2
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wei-Cheng Tseng, Principal Investigator, Tri-Service General Hospital
Dexmedetomidine
Thoracoscopy
Analgesia
Additional relevant MeSH terms:
Dexmedetomidine

Study Results

No Results Posted as of May 18, 2023