Dexmedetomidine in Non-intubated VATS

NCT ID: NCT05863416

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-23

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dexmedetomidine Thoracoscopy Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Saline

Propofol-based total intravenous anesthesia with saline infusion

Group Type ACTIVE_COMPARATOR

Dexmedetomidine infusion

Intervention Type DRUG

Intraoperative dexmedetomidine infusion

Group Dexmedetomidine

Propofol-based total intravenous anesthesia with dexmedetomidine infusion

Group Type EXPERIMENTAL

Dexmedetomidine infusion

Intervention Type DRUG

Intraoperative dexmedetomidine infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine infusion

Intraoperative dexmedetomidine infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wei-Cheng Tseng

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tri-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wei-Cheng Tseng, MD

Role: CONTACT

886-2-8792-3311 ext. 13815

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

WEI-CHENG TSENG

Role: primary

886-913-538165

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34739134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34662540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33008451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36684254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26886651 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B202305049_V2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.