Dexmedetomidine in Non-intubated VATS

NCT05863416 | Recruiting Phase 4

• 1 other identifier: B202305049_V2
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Thoracoscopy; Analgesia

Keywords

Dexmedetomidine; Thoracoscopy; Analgesia

Outcome Measures

Primary Outcomes (1)

• Cough

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

  Intraoperative period

Secondary Outcomes (6)

• Intraoperative fentanyl consumption

  Intraoperative period

• Total fentanyl consumption

  Intraoperative period

• Total propofol consumption

  Intraoperative period

• Intraoperative adverse events

  Intraoperative period

• Postoperative numeric rating scale

  Postoperative 48 hours

Study Arms (2)

Group Saline

ACTIVE COMPARATOR

Propofol-based total intravenous anesthesia with saline infusion

Drug: Dexmedetomidine infusion

Group Dexmedetomidine

EXPERIMENTAL

Propofol-based total intravenous anesthesia with dexmedetomidine infusion

Drug: Dexmedetomidine infusion

Interventions

Dexmedetomidine infusion DRUG

Intraoperative dexmedetomidine infusion

Group Dexmedetomidine; Group Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 34739134 BACKGROUND

• 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.

  PMID: 34662540 BACKGROUND

• 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.

  PMID: 33008451 BACKGROUND

• 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.

  PMID: 36684254 BACKGROUND

• 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.

  PMID: 26886651 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wei-Cheng Tseng, MD

CONTACT

886-2-8792-3311; ndmc_wechern@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 18, 2023
• Study Start: April 23, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)