Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

NCT ID: NCT03825471

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Opioid Use Cytokine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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electrotherapy

Patients undergoing CES and general anesthesia in colon cancer surgery

Group Type EXPERIMENTAL

electrotherapy

Intervention Type PROCEDURE

Cranial electrotherapy stimulation

Opioid Anesthetics

Intervention Type DRUG

consumption of opioids during general anesthesia

colon cancer surgery

Intervention Type PROCEDURE

laparoscopic colon cancer surgery

Opioid Anesthetics

Patients undergoing general anesthesia in colon cancer surgery

Group Type PLACEBO_COMPARATOR

electrotherapy

Intervention Type PROCEDURE

Cranial electrotherapy stimulation

Opioid Anesthetics

Intervention Type DRUG

consumption of opioids during general anesthesia

colon cancer surgery

Intervention Type PROCEDURE

laparoscopic colon cancer surgery

Interventions

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electrotherapy

Cranial electrotherapy stimulation

Intervention Type PROCEDURE

Opioid Anesthetics

consumption of opioids during general anesthesia

Intervention Type DRUG

colon cancer surgery

laparoscopic colon cancer surgery

Intervention Type PROCEDURE

Other Intervention Names

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Opioid consumption during general anesthesia

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi-hsuan Huang

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi-hsuan Huang, MD

Role: PRINCIPAL_INVESTIGATOR

TriService General Hospital

Locations

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TriService General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi-hsuan Huang, MD

Role: CONTACT

+886-2-87927128

Yi-hsuan Huang, MD

Role: CONTACT

+886-2-87927128

Facility Contacts

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Yi-hsuan Huang, MD

Role: primary

+886-2-87927128

References

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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.

Reference Type RESULT
PMID: 24265330 (View on PubMed)

Other Identifiers

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CES and Postoperative pain

Identifier Type: -

Identifier Source: org_study_id

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