Dexmedetomidine in Non-intubated VATS

Analgesia Clinical Trial

Official title:

Adjunctive Dexmedetomidine Infusion in Non-intubated Video-assisted Thoracoscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05863416
• Other study ID #: B202305049_V2
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2023
• Est. completion date: April 2025

Study information

• Verified date: May 2023
• Source: Tri-Service General Hospital
• Contact: Wei-Cheng Tseng, MD
• Phone: 886-2-8792-3311
• Email: ndmc_wechern[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Dexmedetomidine
• Thoracoscopy

Intervention

Drug:
• Dexmedetomidine infusion
Intraoperative dexmedetomidine infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough	The incidence of cough reflex during surgery and severity Cough severity: 1=none, 2=slight, 3=moderate, 4=severe	Intraoperative period
Secondary	Intraoperative fentanyl consumption	Fentanyl bolus for cough reflex and limb movement	Intraoperative period
Secondary	Total fentanyl consumption	Total fentanyl requirement during surgery	Intraoperative period
Secondary	Total propofol consumption	Total propofol requirement during surgery	Intraoperative period
Secondary	Intraoperative adverse events	The incidence of hypotension, bradycardia and hypoxia	Intraoperative period
Secondary	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.	Postoperative 48 hours
Secondary	Postoperative opioid requirement	Postoperative opioid requirement within postoperative 48 hours	Postoperative 48 hours