Colorectal CancerNCT02827682
The Effect of IoC on Analgesia for Elderly Patients With Postoperative Effectiveness
A study testing Angel-6000D Multiparameter Anesthesia Monitor (IoC) and BIS VISTA Monitor (BIS) in people with Colorectal Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The morbidity of colorectal cancer and the surgery number among elderly is growing. The investigators need to provide more advanced and specific monitoring technology for these patients. Index of consciousness (IoC) monitor is now widely used among endoscopy, cholecystectomy and other common clinical applications. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Angel-6000D Multiparameter Anesthesia Monitor (IoC) and BIS VISTA Monitor (BIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to May 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 60 years old that underwent Colorectal surgery in the First Affiliated Hospital of Xi'an Jiaotong University.
Who cannot join
- Having severe comorbidity history,for example,severe cardiac dysfunction
- Having central nervous system disease, severe endocrine, and history of mental disorders
- Alcoholic and long-term use of sedatives and opioids history
- Drug allergy history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
FirstXianJiaotongU
Xi'an, Shaanxi, 710061
QIANG WANG, PHD, 18049286968, dr.wangqiang@139.com
JING XU, MD, 13772052823, xuj0909@163.com
About this study
Official title: The Effect of IoC on the Level of Intraoperative Analgesia for Elderly Patients With Postoperative Effectiveness
The morbidity of colorectal cancer and the surgery number among elderly is growing. The investigators need to provide more advanced and specific monitoring technology for these patients. Index of consciousness (IoC) monitor is now widely used among endoscopy, cholecystectomy and other common clinical applications. The investigators goal is to verify whether using IoC monitor could help to improve the postoperative recovery after colorectal surgery.
Read the detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive IoC monitoring or BIS monitoring during the operation as the criteria for adjustment of analgesics use. The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. The number of dialysis and patient's recovery after the transplantation will be recorded. The participation of each patient is scheduled till they discharge from hospital.
- Conditions
- Colorectal Cancer
- Being tested
- Angel-6000D Multiparameter Anesthesia Monitor (IoC), BIS VISTA Monitor (BIS)
- Keywords
- IoC, monitor, elderly, postoperative effectiveness
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angel-6000D Multiparameter Anesthesia Monitor (IoC)Device
Also called Index of consciousness
The Angel-6000D Multiparameter Anesthesia Monitor, Shenzhen Weihaokang Medical Technology Co., Ltd, Guangdong, China
BIS VISTA Monitor (BIS)Device
Also called Bispectral index
BIS VISTA Monitor, Covidien, Changchun city shi jia trade co., Ltd, Changchun, China
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Using Angel-6000D Multiparameter Anesthesia Monitor to maintain the Hemodynamic stability during surgery. Keep IoC1 40 to 60 while IoC2 30-50.Target concentration of propofol was decreased by 0.5 μg/ml per adjustment when IoC1<40, with a maintenance value between 40 and 60. The target concentration of remifentanil was increased by 1 ng/ml per adjustment when IoC2>50 but was decreased by 1 ng/ml per adjustment when IoC2<30, with the maintenance value between 30 and 50. Receives: Device: Angel-6000D Multiparameter Anesthesia Monitor (IoC) |
| control group | Placebo comparator | Using BIS VISTA Monitor to maintain the Hemodynamic stability during surgery. Keep BIS 40 to 60.The doses of propofol and remifentanil were adjusted by the anesthetists according to BIS. Target concentration of propofol was decreased by 0.5 μg/ml per adjustment when BIS<40, with a maintenance value between 40 and 60. The target concentration of remifentanil was increased by 1 ng/ml per adjustment when BIS>60 but was decreased by 1 ng/ml per adjustment when BIS<40, with the maintenance value between 40 and 60. Receives: Device: BIS VISTA Monitor (BIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration time in PACU
patients able to leave PACU with the proper Aldrete score
Measured: 24 hours
Secondary outcomes (3)
Use of remifentanil
Measured: during surgery
Use of propofol
Measured: during surgery
length of hospital stay (LOS)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Wang, PHD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827682
- Sponsor's protocol ID
- XJTU1AF-CRS-2016-017
- Status last verified
- Jan 2017
- First submitted
- 26 Jun 2016
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of IoC on the Level of Intraoperative Analgesia for Elderly Patients With Postoperative Effectiveness
- ClinicalTrials.gov ID
- NCT02827682
- Acronym / sponsor ID
- XJTU1AF-CRS-2016-017
- Conditions
- Colorectal Cancer
- Keywords
- IoC, monitor, elderly, postoperative effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- 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.
The morbidity of colorectal cancer and the surgery number among elderly is growing. The investigators need to provide more advanced and specific monitoring technology for these patients. Index of consciousness (IoC) monitor is now widely used among endoscopy, cholecystectomy and other common clinical applications. The investigators goal is to verify whether using IoC monitor could help to improve the postoperative recovery after colorectal surgery.
Detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive IoC monitoring or BIS monitoring during the operation as the criteria for adjustment of analgesics use. The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. The number of dialysis and patient's recovery after the transplantation will be recorded. The participation of each patient is scheduled till they discharge from hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: Angel-6000D Multiparameter Anesthesia Monitor (IoC)Using Angel-6000D Multiparameter Anesthesia Monitor to maintain the Hemodynamic stability during surgery. Keep IoC1 40 to 60 while IoC2 30-50.Target concentration of propofol was decreased by 0.5 μg/ml per adjustment when IoC1<40, with a maintenance value between 40 and 60. The target concentration of remifentanil was increased by 1 ng/ml per adjustment when IoC2>50 but was decreased by 1 ng/ml per adjustment when IoC2<30, with the maintenance value between 30 and 50. |
| control group | Placebo comparator | Device: BIS VISTA Monitor (BIS)Using BIS VISTA Monitor to maintain the Hemodynamic stability during surgery. Keep BIS 40 to 60.The doses of propofol and remifentanil were adjusted by the anesthetists according to BIS. Target concentration of propofol was decreased by 0.5 μg/ml per adjustment when BIS<40, with a maintenance value between 40 and 60. The target concentration of remifentanil was increased by 1 ng/ml per adjustment when BIS>60 but was decreased by 1 ng/ml per adjustment when BIS<40, with the maintenance value between 40 and 60. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged over 60 years old that underwent Colorectal surgery in the First Affiliated Hospital of Xi'an Jiaotong University.
Key exclusion criteria (4 listed)
- Having severe comorbidity history,for example,severe cardiac dysfunction
- Having central nervous system disease, severe endocrine, and history of mental disorders
- Alcoholic and long-term use of sedatives and opioids history
- Drug allergy history.
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 |
|---|---|---|
| Angel-6000D Multiparameter Anesthesia Monitor (IoC)Also: Index of consciousnessThe Angel-6000D Multiparameter Anesthesia Monitor, Shenzhen Weihaokang Medical Technology Co., Ltd, Guangdong, China | Device | study group |
| BIS VISTA Monitor (BIS)Also: Bispectral indexBIS VISTA Monitor, Covidien, Changchun city shi jia trade co., Ltd, Changchun, China | Device | control group |
Primary outcome
Duration time in PACU
Time frame: 24 hours
patients able to leave PACU with the proper Aldrete score
3 secondary outcomes
Use of remifentanil
Time frame: during surgery
Use of propofol
Time frame: during surgery
length of hospital stay (LOS)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Qiang Wang, PHD study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angel-6000D Multiparameter Anesthesia Monitor (IoC) and BIS VISTA Monitor (BIS) in people with Colorectal Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 4 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 20 Jan 2017. 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 China. 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 Jing Xu, MD (13772052823, xuj0909@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration time in PACU (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2017.