Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

Not Applicable

• Conditions: Opioid Use; Cytokine
• Interventions: Procedure: electrotherapy; Drug: Opioid Anesthetics; Procedure: colon cancer surgery

• Registration Number: NCT03825471
• Lead Sponsor: Tri-Service General Hospital

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.

Study Timeline

• Study Start: 2019-01-14
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electrotherapy	electrotherapy	Patients undergoing CES and general anesthesia in colon cancer surgery
electrotherapy	Opioid Anesthetics	Patients undergoing CES and general anesthesia in colon cancer surgery
electrotherapy	colon cancer surgery	Patients undergoing CES and general anesthesia in colon cancer surgery
Opioid Anesthetics	electrotherapy	Patients undergoing general anesthesia in colon cancer surgery
Opioid Anesthetics	Opioid Anesthetics	Patients undergoing general anesthesia in colon cancer surgery
Opioid Anesthetics	colon cancer surgery	Patients undergoing general anesthesia in colon cancer surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

TriService General Hospital; 🇨🇳 Taipei, Taiwan