Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain
NCT ID: NCT03825471
Last Updated: 2020-03-11
Study Results
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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2019-01-14
2020-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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electrotherapy
Patients undergoing CES and general anesthesia in colon cancer surgery
electrotherapy
Cranial electrotherapy stimulation
Opioid Anesthetics
consumption of opioids during general anesthesia
colon cancer surgery
laparoscopic colon cancer surgery
Opioid Anesthetics
Patients undergoing general anesthesia in colon cancer surgery
electrotherapy
Cranial electrotherapy stimulation
Opioid Anesthetics
consumption of opioids during general anesthesia
colon cancer surgery
laparoscopic colon cancer surgery
Interventions
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electrotherapy
Cranial electrotherapy stimulation
Opioid Anesthetics
consumption of opioids during general anesthesia
colon cancer surgery
laparoscopic colon cancer surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
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Tri-Service General Hospital
OTHER
Responsible Party
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Yi-hsuan Huang
Attending Physician
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
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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CES and Postoperative pain
Identifier Type: -
Identifier Source: org_study_id
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