Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

Study Overview
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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.

Official Title
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Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery

Conditions
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Opioid Use, Cytokine

Intervention / Treatment
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* Procedure: electrotherapy
* Drug: Opioid Anesthetics
* Procedure: colon cancer surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrotherapy<br>Patients undergoing CES and general anesthesia in colon cancer surgery | Procedure: electrotherapy<br>* Cranial electrotherapy stimulation<br>Drug: Opioid Anesthetics<br>* consumption of opioids during general anesthesia<br>* Other names: Opioid consumption during general anesthesia;Procedure: colon cancer surgery<br>* laparoscopic colon cancer surgery<br>|
| Placebo Comparator: Opioid Anesthetics<br>Patients undergoing general anesthesia in colon cancer surgery | Procedure: electrotherapy<br>* Cranial electrotherapy stimulation<br>Drug: Opioid Anesthetics<br>* consumption of opioids during general anesthesia<br>* Other names: Opioid consumption during general anesthesia;Procedure: colon cancer surgery<br>* laparoscopic colon cancer surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dosage of patient-controlled analgesia (PCA) consumption | postoperative PCA consumption | from the end of the surgery to postoperative 72 hours | 
| serum concentration of serum cytokine | proinflammatory and antiinflammatory cytokines (IL-1a, IL-2, IL-6, IL-7, TNF-a, IL-4, IL-10, IL-10, IL-1, TGF-b) | from the beginning of the surgery to postoperative 72 hours | 
| Number of Participants with CES and control groups | patient characteristics | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer surgery, patient-controlled analgesia (PCA), Cranial electrotherapy stimulation (CES), Autonomic nervous system, acute postoperative pain