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Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

Sponsor
Tri-Service General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03825471
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
23.6
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: electrotherapy
  • Drug: Opioid Anesthetics
  • Procedure: colon cancer surgery
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery
Actual Study Start Date :
Jan 14, 2019
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. dosage of intraoperative anesthetics [during surgery]

      The consumption of total amount of supplemental analgesics administered during colon cancer surgery

    2. Rescue analgesics [from the end of the surgery to postoperative 72 hours]

      The consumption of total amount of rescue analgesics administered after colon cancer surgery

    3. Differences in Pain Intensity Between CES intervention and the control group [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

    Secondary Outcome Measures

    1. dosage of patient-controlled analgesia (PCA) consumption [from the end of the surgery to postoperative 72 hours]

      postoperative PCA consumption

    2. serum concentration of serum cytokine [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)

    3. Number of Participants with CES and control groups [during surgery]

      patient characteristics

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TriService General Hospital Taipei Taiwan 11490

    Sponsors and Collaborators

    • Tri-Service General Hospital

    Investigators

    • Principal Investigator: Yi-hsuan Huang, MD, TriService General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yi-hsuan Huang, Attending Physician, Tri-Service General Hospital
    ClinicalTrials.gov Identifier:
    NCT03825471
    Other Study ID Numbers:
    • CES and Postoperative pain
    First Posted:
    Jan 31, 2019
    Last Update Posted:
    Mar 11, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Yi-hsuan Huang, Attending Physician, Tri-Service General Hospital
    Cranial electrotherapy stimulation (CES)
    Autonomic nervous system
    acute postoperative pain
    colon cancer surgery
    patient-controlled analgesia (PCA)
    Additional relevant MeSH terms:
    Pain, Postoperative
    Analgesics, Opioid
    Anesthetics

    Study Results

    No Results Posted as of Mar 11, 2020