Opioid Use, Cytokine
Conditions
Keywords
Cranial electrotherapy stimulation (CES), Autonomic nervous system, acute postoperative pain, colon cancer surgery, patient-controlled analgesia (PCA)
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.
Interventions
PROCEDUREelectrotherapy
Cranial electrotherapy stimulation
consumption of opioids during general anesthesia
PROCEDUREcolon cancer surgery
laparoscopic colon cancer surgery
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dosage of intraoperative anesthetics | during surgery | The consumption of total amount of supplemental analgesics administered during colon cancer surgery |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| dosage of patient-controlled analgesia (PCA) consumption | from the end of the surgery to postoperative 72 hours | postoperative PCA consumption |
| 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) |
| Number of Participants with CES and control groups | during surgery | patient characteristics |
Countries
Taiwan
Contacts
Primary ContactYi-hsuan Huang, MD
Backup ContactYi-hsuan Huang, MD
Outcome results
None listed