Dexmedetomidine in Non-intubated VATS

May 16, 2023 updated by: Wei-Cheng Tseng, Tri-Service General Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough
Time Frame: Intraoperative period
The incidence of cough reflex during surgery and severity Cough severity: 1=none, 2=slight, 3=moderate, 4=severe
Intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative fentanyl consumption
Time Frame: Intraoperative period
Fentanyl bolus for cough reflex and limb movement
Intraoperative period
Total fentanyl consumption
Time Frame: Intraoperative period
Total fentanyl requirement during surgery
Intraoperative period
Total propofol consumption
Time Frame: Intraoperative period
Total propofol requirement during surgery
Intraoperative period
Intraoperative adverse events
Time Frame: Intraoperative period
The incidence of hypotension, bradycardia and hypoxia
Intraoperative period
Postoperative numeric rating scale
Time Frame: 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.
Postoperative 48 hours
Postoperative opioid requirement
Time Frame: Postoperative 48 hours
Postoperative opioid requirement within postoperative 48 hours
Postoperative 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B202305049_V2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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