NCT03825471

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

January 22, 2019

Last Update Submit

March 9, 2020

Conditions

Opioid UseCytokine

Keywords

Cranial electrotherapy stimulation (CES)Autonomic nervous systemacute postoperative paincolon cancer surgerypatient-controlled analgesia (PCA)

Outcome Measures

Primary Outcomes (3)

  • dosage of intraoperative anesthetics

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

    during surgery

  • Rescue analgesics

    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

    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 Outcomes (3)

  • dosage of patient-controlled analgesia (PCA) consumption

    from the end of the surgery to postoperative 72 hours

  • serum concentration of serum cytokine

    from the beginning of the surgery to postoperative 72 hours

  • Number of Participants with CES and control groups

    during surgery

Study Arms (2)

electrotherapy

EXPERIMENTAL

Patients undergoing CES and general anesthesia in colon cancer surgery

Procedure: electrotherapyDrug: Opioid AnestheticsProcedure: colon cancer surgery

Opioid Anesthetics

PLACEBO COMPARATOR

Patients undergoing general anesthesia in colon cancer surgery

Procedure: electrotherapyDrug: Opioid AnestheticsProcedure: colon cancer surgery

Interventions

electrotherapyPROCEDURE

Cranial electrotherapy stimulation

Opioid Anestheticselectrotherapy
Opioid AnestheticsDRUG

consumption of opioids during general anesthesia

Also known as: Opioid consumption during general anesthesia
Opioid Anestheticselectrotherapy
colon cancer surgeryPROCEDURE

laparoscopic colon cancer surgery

Opioid Anestheticselectrotherapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing colon cancer surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TriService General Hospital

Taipei, 11490, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24265330RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Yi-hsuan Huang, MD

    TriService General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-hsuan Huang, MD

CONTACT

+886-2-87927128yixiun72@gmail.com

Yi-hsuan Huang, MD

CONTACT

+886-2-87927128yixun72@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 31, 2019

Study Start

January 14, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)