Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

March 9, 2020 updated by: Yi-hsuan Huang, Tri-Service General Hospital

Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11490
        • Recruiting
        • TriService General Hospital
        • 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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: electrotherapy
Patients undergoing CES and general anesthesia in colon cancer surgery
Procedure: electrotherapy
Cranial electrotherapy stimulation
Drug: Opioid Anesthetics
consumption of opioids during general anesthesia
Other Names:
  • Opioid consumption during general anesthesia
Procedure: colon cancer surgery
laparoscopic colon cancer surgery
Placebo Comparator: Opioid Anesthetics
Patients undergoing general anesthesia in colon cancer surgery
Procedure: electrotherapy
Cranial electrotherapy stimulation
Drug: Opioid Anesthetics
consumption of opioids during general anesthesia
Other Names:
  • Opioid consumption during general anesthesia
Procedure: colon cancer surgery
laparoscopic colon cancer surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dosage of patient-controlled analgesia (PCA) consumption
Time Frame: from the end of the surgery to postoperative 72 hours
postoperative PCA consumption
from the end of the surgery to postoperative 72 hours
serum concentration of serum cytokine
Time Frame: from the beginning of the surgery to postoperative 72 hours
proinflammatory and antiinflammatory cytokines (IL-1a, IL-2, IL-6, IL-7, TNF-a, IL-4, IL-10, IL-10, IL-1, TGF-b)
from the beginning of the surgery to postoperative 72 hours
Number of Participants with CES and control groups
Time Frame: during surgery
patient characteristics
during surgery

Collaborators and Investigators

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

Sponsor

Tri-Service General Hospital

Investigators

  • Principal Investigator: Yi-hsuan Huang, MD, TriService 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 (Actual)

January 14, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CES and Postoperative pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

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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