Opioid UseNCT03825471
Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain
A study testing electrotherapy, Opioid Anesthetics and colon cancer surgery in people with Opioid Use and Cytokine, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Opioid Use, Cytokine
- What is being tested?
- electrotherapy, Opioid Anesthetics and colon cancer surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing colon cancer surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
TriService General Hospital
Taipei, 11490
Yi-hsuan Huang, MD, +886-2-87927128, yixiun72@gmail.com
About this study
Official title: Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery
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.
Read the 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.
- Conditions
- Opioid Use, Cytokine
- Being tested
- electrotherapy, Opioid Anesthetics, colon cancer surgery
- Keywords
- Cranial electrotherapy stimulation (CES), Autonomic nervous system, acute postoperative pain, colon cancer surgery, patient-controlled analgesia (PCA)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrotherapyProcedure or surgery
Cranial electrotherapy stimulation
Opioid AnestheticsDrug
Also called Opioid consumption during general anesthesia
consumption of opioids during general anesthesia
colon cancer surgeryProcedure or surgery
laparoscopic colon cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| electrotherapy | Experimental | Patients undergoing CES and general anesthesia in colon cancer surgery Receives: Procedure: electrotherapy; Drug: Opioid Anesthetics; Procedure: colon cancer surgery |
| Opioid Anesthetics | Placebo comparator | Patients undergoing general anesthesia in colon cancer surgery Receives: Procedure: electrotherapy; Drug: Opioid Anesthetics; Procedure: colon cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosage of intraoperative anesthetics
The consumption of total amount of supplemental analgesics administered during colon cancer surgery
Measured: during surgery
Rescue analgesics
The consumption of total amount of rescue analgesics administered after colon cancer surgery
Measured: 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
Measured: from the end of the surgery to postoperative 72 hours
Secondary outcomes (3)
dosage of patient-controlled analgesia (PCA) consumption
postoperative PCA consumption
Measured: 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)
Measured: from the beginning of the surgery to postoperative 72 hours
Number of Participants with CES and control groups
patient characteristics
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start14 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-hsuan Huang, Tri-Service General Hospital (TSGH)
- Investigators
- Yi-hsuan Huang, MD, Principal investigator, TriService General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825471
- Sponsor's protocol ID
- CES and Postoperative pain
- Status last verified
- Mar 2020
- First submitted
- 22 Jan 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24265330
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery
- ClinicalTrials.gov ID
- NCT03825471
- Acronym / sponsor ID
- CES and Postoperative pain
- Conditions
- Opioid Use, Cytokine
- Keywords
- Cranial electrotherapy stimulation (CES), Autonomic nervous system, acute postoperative pain, colon cancer surgery, patient-controlled analgesia (PCA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrotherapy | Experimental | Procedure: electrotherapy, Drug: Opioid Anesthetics, Procedure: colon cancer surgeryPatients undergoing CES and general anesthesia in colon cancer surgery |
| Opioid Anesthetics | Placebo comparator | Procedure: electrotherapy, Drug: Opioid Anesthetics, Procedure: colon cancer surgeryPatients undergoing general anesthesia in colon cancer surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing colon cancer surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrotherapyCranial electrotherapy stimulation | Procedure or surgery | Opioid Anesthetics, electrotherapy |
| Opioid AnestheticsAlso: Opioid consumption during general anesthesiaconsumption of opioids during general anesthesia | Drug | Opioid Anesthetics, electrotherapy |
| colon cancer surgerylaparoscopic colon cancer surgery | Procedure or surgery | Opioid Anesthetics, electrotherapy |
Primary outcome
dosage of intraoperative anesthetics
Time frame: during surgery
The consumption of total amount of supplemental analgesics administered during colon cancer surgery
Rescue analgesics
Time frame: 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
Time frame: 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
3 secondary outcomes
dosage of patient-controlled analgesia (PCA) consumption
Time frame: from the end of the surgery to postoperative 72 hours
serum concentration of serum cytokine
Time frame: from the beginning of the surgery to postoperative 72 hours
Number of Participants with CES and control groups
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Results publication: PubMed 24265330Lee 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.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-hsuan Huang, MD principal investigator
TriService General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrotherapy, Opioid Anesthetics and colon cancer surgery in people with Opioid Use and Cytokine, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-hsuan Huang, MD (+886-2-87927128, yixiun72@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dosage of intraoperative anesthetics (time frame: during surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03825471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.