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Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

Primary Purpose

Opioid Use, Cytokine

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
electrotherapy
Opioid Anesthetics
colon cancer surgery
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring Cranial electrotherapy stimulation (CES), Autonomic nervous system, acute postoperative pain, colon cancer surgery, patient-controlled analgesia (PCA)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing colon cancer surgery

Exclusion Criteria:

  • presence of an implantable device (e.g., pacemaker)
  • pregnancy
  • having a known mental illness (e.g., schizophrenia, mood disorder, bipolar disorder, etc.
  • cancer of the head and neck or brain tumor or brain metastasis
  • having delirium

Sites / Locations

  • TriService General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

electrotherapy

Opioid Anesthetics

Arm Description

Patients undergoing CES and general anesthesia in colon cancer surgery

Patients undergoing general anesthesia in colon cancer surgery

Outcomes

Primary Outcome Measures

dosage of intraoperative anesthetics
The consumption of total amount of supplemental analgesics administered during colon cancer surgery
Rescue analgesics
The consumption of total amount of rescue analgesics administered after colon cancer surgery
Differences in Pain Intensity Between CES intervention and the control group
Pain assessment of NRS pain intensity scores and patient satisfaction assessed by the NRS through end of surgery to postoperative 72 hours

Secondary Outcome Measures

dosage of patient-controlled analgesia (PCA) consumption
postoperative PCA consumption
serum concentration of serum cytokine
proinflammatory and antiinflammatory cytokines (IL-1a, IL-2, IL-6, IL-7, TNF-a, IL-4, IL-10, IL-10, IL-1, TGF-b)
Number of Participants with CES and control groups
patient characteristics

Full Information

First Posted
January 22, 2019
Last Updated
March 9, 2020
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03825471
Brief Title
Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain
Official Title
Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cranial electrotherapy stimulation (CES) is a non-invasive intervention to treat anxiety, depression, insomnia, and pain. But clinical studies and applications of CES in relation to acute postoperative pain are few. tThe investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery.
Detailed Description
Cranial electrotherapy stimulation (CES) is a non-invasive and safe intervention, transmitting microcurrents of brain stimulation and releasing various neurotransmitters such as endorphin and downstream hormones to modulate autonomic nervous system, as a result, for treating anxiety, depression, insomnia, and pain. Acute postoperative pain annoys patients receiving surgery. Once acute postoperative pain is poorly controlled, it may result in adverse acute effects (i.e., physiologic and psychologic stress), chronic effects (i.e., delayed long-term recovery and chronic pain), and, in consequence, excess length of hospitalization and extra costs. Besides, inflammatory reactions mediated by immune system are formed after tissue injury (e.g. trauma, surgery, etc), release serial inflammatory cytokines and are related to pain signal transmission. However, clinical studies and applications of CES focus on management of chronic pain, modulation of mood and insomnia rather than acute postoperative pain in recent years. The investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery. The investigators also collect blood samples before and after surgery for analysis of serum cytokines. Meanwhile, Bispectral IndexTM (BISTM) monitoring and Analgesia Nociception Index (ANI) are prescribed during the surgery not only for measuring of the effects of anesthetics and sedatives on the brain, but also evaluating perioperative analgesia. Thereby, the effectiveness of CES for management of acute postoperative pain may introduce clinicians for alternative application of pain control after surgery in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Cytokine
Keywords
Cranial electrotherapy stimulation (CES), Autonomic nervous system, acute postoperative pain, colon cancer surgery, patient-controlled analgesia (PCA)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
electrotherapy
Arm Type
Experimental
Arm Description
Patients undergoing CES and general anesthesia in colon cancer surgery
Arm Title
Opioid Anesthetics
Arm Type
Placebo Comparator
Arm Description
Patients undergoing general anesthesia in colon cancer surgery
Intervention Type
Procedure
Intervention Name(s)
electrotherapy
Intervention Description
Cranial electrotherapy stimulation
Intervention Type
Drug
Intervention Name(s)
Opioid Anesthetics
Other Intervention Name(s)
Opioid consumption during general anesthesia
Intervention Description
consumption of opioids during general anesthesia
Intervention Type
Procedure
Intervention Name(s)
colon cancer surgery
Intervention Description
laparoscopic colon cancer surgery
Primary Outcome Measure Information:
Title
dosage of intraoperative anesthetics
Description
The consumption of total amount of supplemental analgesics administered during colon cancer surgery
Time Frame
during surgery
Title
Rescue analgesics
Description
The consumption of total amount of rescue analgesics administered after colon cancer surgery
Time Frame
from the end of the surgery to postoperative 72 hours
Title
Differences in Pain Intensity Between CES intervention and the control group
Description
Pain assessment of NRS pain intensity scores and patient satisfaction assessed by the NRS through end of surgery to postoperative 72 hours
Time Frame
from the end of the surgery to postoperative 72 hours
Secondary Outcome Measure Information:
Title
dosage of patient-controlled analgesia (PCA) consumption
Description
postoperative PCA consumption
Time Frame
from the end of the surgery to postoperative 72 hours
Title
serum concentration of serum cytokine
Description
proinflammatory and antiinflammatory cytokines (IL-1a, IL-2, IL-6, IL-7, TNF-a, IL-4, IL-10, IL-10, IL-1, TGF-b)
Time Frame
from the beginning of the surgery to postoperative 72 hours
Title
Number of Participants with CES and control groups
Description
patient characteristics
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing colon cancer surgery Exclusion Criteria: presence of an implantable device (e.g., pacemaker) pregnancy having a known mental illness (e.g., schizophrenia, mood disorder, bipolar disorder, etc. cancer of the head and neck or brain tumor or brain metastasis having delirium
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-hsuan Huang, MD
Phone
+886-2-87927128
Email
yixiun72@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-hsuan Huang, MD
Phone
+886-2-87927128
Email
yixun72@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-hsuan Huang, MD
Organizational Affiliation
TriService General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
TriService General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-hsuan Huang, MD
Phone
+886-2-87927128
Email
yixiun72@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24265330
Citation
Lee SH, Kim WY, Lee CH, Min TJ, Lee YS, Kim JH, Park YC. Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response. J Int Med Res. 2013 Dec;41(6):1788-95. doi: 10.1177/0300060513500749.
Results Reference
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Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

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