Clinical trial NCT03825471: Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain
Official title: Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Cytokine
Keywords: Cranial electrotherapy stimulation (CES)
Autonomic nervous system
acute postoperative pain
colon cancer surgery
patient-controlled analgesia (PCA)
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: dosage of intraoperative anesthetics
timeFrame: during surgery
measure: Rescue analgesics
timeFrame: from the end of the surgery to postoperative 72 hours
measure: Differences in Pain Intensity Between CES intervention and the control group
timeFrame: from the end of the surgery to postoperative 72 hours
Secondary outcomes:
measure: dosage of patient-controlled analgesia (PCA) consumption
timeFrame: from the end of the surgery to postoperative 72 hours
measure: serum concentration of serum cytokine
timeFrame: from the beginning of the surgery to postoperative 72 hours
measure: Number of Participants with CES and control groups
timeFrame: during surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: TriService General Hospital
Study officials:
affiliation: TriService General Hospital
name: Yi-hsuan Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.