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Effect of General Anesthesia Combined Dexmedetomidine on Opioids Intraoperatively and Postoperatively in Patients With Lung Cancer Surgery

Primary Purpose

Opioid Use, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring Dexmedetomidine, Opioid-free anesthesia, Non-small Cell Lung Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age older than 20 years old and younger than 75 years old
  • Diagnosed as stage I-III non-small cell lung cancer
  • Received video-assisted thoracoscopic lung wedge resection or lobectomy

Exclusion Criteria:

  • Cardiac arrhythmia , such as sinus bradycardia, sinus tachycardia, or high-degree atrioventricular block
  • Diagnosed acute myocardial myocardial infarction, congestive heart failure, or stroke within one year
  • Patient have underwent coronary artery bypass graft
  • Allergy to drug such as Propofol, Sevoflurane, Dexmedetomidine, NSAID, Lidocaine)

Sites / Locations

  • Kaohsiung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Total intravenous anesthesia (TIVA) + Dexmedetomidine

Total intravenous anesthesia (TIVA)

Inhalation anesthesia plus Dexmedetomidine

Inhalation anesthesia

Arm Description

Total intravenous anesthetic drug is propofol. Dexmedetomidine is infused continuously.

Total intravenous anesthetic drug is propofol. The ordinary pain is controlled mainly by opioids.

Inhalation aneshetic drug is Sevoflurane. Dexmedetomidine is infused continuously.

Inhalation aneshetic drug is Sevoflurane. The ordinary pain is controlled mainly by opioids.

Outcomes

Primary Outcome Measures

The peri-operative dose of opioid
Calculate the total dose of opioid

Secondary Outcome Measures

Postoperative pain scale
The pain scale will be assessed postoperatively

Full Information

First Posted
June 14, 2022
Last Updated
October 6, 2022
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT05431322
Brief Title
Effect of General Anesthesia Combined Dexmedetomidine on Opioids Intraoperatively and Postoperatively in Patients With Lung Cancer Surgery
Official Title
Effect of General Anesthesia Combined Dexmedetomidine on Opioids Intraoperatively and Postoperatively in Patients With Lung Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Numerous studies in recent years have shown that the use of opioid-free analgesia can reduce opioid use and length of stay in the recovery room, as published in the journals Anesthesia & Analgesia1. Compared with traditional opioid analgesic anesthesia, opioid-free analgesic anesthesia can be used to reduce postoperative respiratory complications, postoperative nausea and vomiting, and postoperative opioid needs. During surgery, opioid analgesics may have immunosuppressive effects, but different anesthesia/analgesia methods will change the individual's stress response, affect the human body's cellular immunity, and may even lead to changes in angiogenesis growth factors associated with cancer recurrence, so it is likely to affect the prognosis of cancer patients. In addition, Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, can replace opioids for pain relief during surgery, providing superior analgesia and reducing opioid use while reducing the need for general anesthetics amount, thus avoiding suppression of immune system function. A study in the Journal of Anaesthesiology Clinical Pharmacology pointed out that Dexmedetomidine can be used to replace opioid analgesics in surgical anesthesia, and there was no difference in the use of rescue opioid analgesics during and after surgery5. Several clinical studies have shown that opioid-free anesthesia is significantly associated with a lower incidence of respiratory complications and postoperative nausea and vomiting. Therefore, general anesthesia combined with Dexmedetomidine can be regarded as an opioid-free anesthesia strategy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Postoperative Pain
Keywords
Dexmedetomidine, Opioid-free anesthesia, Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total intravenous anesthesia (TIVA) + Dexmedetomidine
Arm Type
Experimental
Arm Description
Total intravenous anesthetic drug is propofol. Dexmedetomidine is infused continuously.
Arm Title
Total intravenous anesthesia (TIVA)
Arm Type
No Intervention
Arm Description
Total intravenous anesthetic drug is propofol. The ordinary pain is controlled mainly by opioids.
Arm Title
Inhalation anesthesia plus Dexmedetomidine
Arm Type
Experimental
Arm Description
Inhalation aneshetic drug is Sevoflurane. Dexmedetomidine is infused continuously.
Arm Title
Inhalation anesthesia
Arm Type
No Intervention
Arm Description
Inhalation aneshetic drug is Sevoflurane. The ordinary pain is controlled mainly by opioids.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Initially give loading dose with 0.5 mcg/kg for 10 min and then keep maintenance dose with 0.5 mcg/kg/h until two-lung ventilation then 0.3 mcg/kg/h until the end of suture.
Primary Outcome Measure Information:
Title
The peri-operative dose of opioid
Description
Calculate the total dose of opioid
Time Frame
up to three days
Secondary Outcome Measure Information:
Title
Postoperative pain scale
Description
The pain scale will be assessed postoperatively
Time Frame
up to three days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 20 years old and younger than 75 years old Diagnosed as stage I-III non-small cell lung cancer Received video-assisted thoracoscopic lung wedge resection or lobectomy Exclusion Criteria: Cardiac arrhythmia , such as sinus bradycardia, sinus tachycardia, or high-degree atrioventricular block Diagnosed acute myocardial myocardial infarction, congestive heart failure, or stroke within one year Patient have underwent coronary artery bypass graft Allergy to drug such as Propofol, Sevoflurane, Dexmedetomidine, NSAID, Lidocaine)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Wei Hsieh
Phone
886978466062
Email
kwhsieh1011@vghks.gov.tw
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung city
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
886-7-342-2121

12. IPD Sharing Statement

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Effect of General Anesthesia Combined Dexmedetomidine on Opioids Intraoperatively and Postoperatively in Patients With Lung Cancer Surgery

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