AzTrials
AzTrials

DexmedetomidinePhase 4NCT05863416

Dexmedetomidine in Non-intubated VATS

A Phase 4 study testing Dexmedetomidine infusion in people with Dexmedetomidine and Thoracoscopy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Dexmedetomidine, Thoracoscopy, Analgesia
What is being tested?
Dexmedetomidine infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteTaiwan
Study dates
23 Apr 2024to 28 Mar 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Tri-Service General Hospital

    Taipei, 114

Other trials in Taiwan

About this study

Official title: Adjunctive Dexmedetomidine Infusion in Non-intubated Video-assisted Thoracoscopic Surgery

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.

Read the 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.

Being tested
Dexmedetomidine infusion
Keywords
Dexmedetomidine, Thoracoscopy, Analgesia
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine infusionDrug

    Intraoperative dexmedetomidine infusion

Study groups in NCT05863416
Study groupRoleWhat they receive
Group SalineActive comparatorPropofol-based total intravenous anesthesia with saline infusion
Receives: Drug: Dexmedetomidine infusion
Group DexmedetomidineExperimentalPropofol-based total intravenous anesthesia with dexmedetomidine infusion
Receives: Drug: Dexmedetomidine infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cough

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

    Measured: Intraoperative period

Secondary outcomes (6)

  1. Intraoperative fentanyl consumption

    Fentanyl bolus for cough reflex and limb movement

    Measured: Intraoperative period

  2. Total fentanyl consumption

    Total fentanyl requirement during surgery

    Measured: Intraoperative period

  3. Total propofol consumption

    Total propofol requirement during surgery

    Measured: Intraoperative period

  4. Intraoperative adverse events

    The incidence of hypotension, bradycardia and hypoxia

    Measured: Intraoperative period

  5. Postoperative numeric rating scale

    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.

    Measured: Postoperative 48 hours

  6. Postoperative opioid requirement

    Postoperative opioid requirement within postoperative 48 hours

    Measured: Postoperative 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start23 Apr 2024
  3. Primary completion30 Jan 2026
  4. Study completion28 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05863416
Sponsor's protocol ID
B202305049_V2
Status last verified
May 2026
First submitted
3 May 2023
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share

Publications

  • Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5.

    PubMed 34739134

  • Selim J, Jarlier X, Clavier T, Boujibar F, Dusseaux MM, Thill J, Borderelle C, Ple V, Baste JM, Besnier E, Djerada Z, Compere V. Impact of Opioid-free Anesthesia After Video-assisted Thoracic Surgery: A Propensity Score Study. Ann Thorac Surg. 2022 Jul;114(1):218-224. doi: 10.1016/j.athoracsur.2021.09.014. Epub 2021 Oct 15.

    PubMed 34662540

  • Wang YL, Kong XQ, Ji FH. Effect of dexmedetomidine on intraoperative Surgical Pleth Index in patients undergoing video-assisted thoracoscopic lung lobectomy. J Cardiothorac Surg. 2020 Oct 2;15(1):296. doi: 10.1186/s13019-020-01346-1.

    PubMed 33008451

  • Wang XR, Jia XY, Jiang YY, Li ZP, Zhou QH. Opioid-free anesthesia for postoperative recovery after video-assisted thoracic surgery: A prospective, randomized controlled trial. Front Surg. 2023 Jan 6;9:1035972. doi: 10.3389/fsurg.2022.1035972. eCollection 2022.

    PubMed 36684254

  • Lee SH, Lee CY, Lee JG, Kim N, Lee HM, Oh YJ. Intraoperative Dexmedetomidine Improves the Quality of Recovery and Postoperative Pulmonary Function in Patients Undergoing Video-assisted Thoracoscopic Surgery: A CONSORT-Prospective, Randomized, Controlled Trial. Medicine (Baltimore). 2016 Feb;95(7):e2854. doi: 10.1097/MD.0000000000002854.

    PubMed 26886651

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine infusion in people with Dexmedetomidine and Thoracoscopy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cough (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05863416, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in