Oxidative StressNCT02792751
Does the Use of Bispectral Index Reduce the Oxidative Stress in Endoscopic Retrograde Cholangiopancreatography?
A study testing Bispectral Index Monitorisation (BIS) and Ramsey Sedation Scale in people with Oxidative Stress, run by Antalya Training and Research Hospital.
Trial summary
Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Bispectral Index Monitorisation (BIS) and Ramsey Sedation Scale
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Oct 2015
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists physical status I-II
- Patients undergoing ERCP procedures
Who cannot join
- uncontrolled comorbidities (hypertension, diabetes mellitus, kidney-liver failure)
- difficulty in communication (language problems, such as deafness)
- who are allergic to the drugs used
- pregnant women
About this study
Official title: Effects of Bispectral Index on Oxidative Stress
Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or general anesthesia. The investigators primary outcome was to evaluate the effects of the depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation during the ERCP procedure by analyzing the biochemical parameters. And their secondary outcome was the effects of anesthesia depth on propofol consumption and postoperative sedation status.
Read the detailed description
50 patients undergoing ERCP procedure were randomly allocated in two groups. Propofol was given to provide the patients Ramsey sedation scale as 3 and 4 in Group R (n=25) patients whereas it was given to Group B (n=25) patients to provide BIS values between 65 to 85. The levels of total oxidant status (TOS), total antioxidant status (TAS), and Oxidative stres index (OSI) were measured. Hemodynamic signs, propofol consumption, postoperative recovery time were recorded.
- Conditions
- Oxidative Stress
- Being tested
- Bispectral Index Monitorisation (BIS), Ramsey Sedation Scale
- Keywords
- Depth of anesthesia, BIS, ERCP, Positive Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral Index Monitorisation (BIS)Device
Standard monitoring was performed with electrocardiography, pulse oximetry and non invasive blood pressure. Additionally, Bispectral index (Aspect Medical Systems, Natica, MA) electrodes were connected to Group B patients
Ramsey Sedation ScaleOther
Propofol administration was done to keep the Ramsey Sedation scale of 3 or 4
| Study group | Role | What they receive |
|---|---|---|
| Group R (Ramsey)=25 patients | Active comparator | Propofol infusion was administered to provide Ramsey Sedation Scale 3-4 in Group R Receives: Other: Ramsey Sedation Scale |
| Group B (BIS)=25 patients | Experimental | Propofol infusion was given to maintain the Bispectral index monitorisation (BIS) levels between 60 and 85 in Group B. Receives: Device: Bispectral Index Monitorisation (BIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of BIS on oxidative stress
The investigators aimed to investigate the effects of anesthesia with monitoring the depth of anesthesia using BIS on oxidative stres by measuring the total oxidant status (TAS) and total antioxidant status (TOS) , propofol consumption, and postoperative recovery during ERCP procedures in this study.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792751
- Sponsor's protocol ID
- 123
- Status last verified
- May 2016
- First submitted
- 27 May 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bispectral Index on Oxidative Stress
- ClinicalTrials.gov ID
- NCT02792751
- Acronym / sponsor ID
- 123
- Conditions
- Oxidative Stress
- Keywords
- Depth of anesthesia, BIS, ERCP, Positive Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Jun 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.
Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or general anesthesia. The investigators primary outcome was to evaluate the effects of the depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation during the ERCP procedure by analyzing the biochemical parameters. And their secondary outcome was the effects of anesthesia depth on propofol consumption and postoperative sedation status.
Detailed description
50 patients undergoing ERCP procedure were randomly allocated in two groups. Propofol was given to provide the patients Ramsey sedation scale as 3 and 4 in Group R (n=25) patients whereas it was given to Group B (n=25) patients to provide BIS values between 65 to 85. The levels of total oxidant status (TOS), total antioxidant status (TAS), and Oxidative stres index (OSI) were measured. Hemodynamic signs, propofol consumption, postoperative recovery time were recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R (Ramsey)=25 patients | Active comparator | Other: Ramsey Sedation ScalePropofol infusion was administered to provide Ramsey Sedation Scale 3-4 in Group R |
| Group B (BIS)=25 patients | Experimental | Device: Bispectral Index Monitorisation (BIS)Propofol infusion was given to maintain the Bispectral index monitorisation (BIS) levels between 60 and 85 in Group B. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with American Society of Anesthesiologists physical status I-II
- Patients undergoing ERCP procedures
Key exclusion criteria (4 listed)
- uncontrolled comorbidities (hypertension, diabetes mellitus, kidney-liver failure)
- difficulty in communication (language problems, such as deafness)
- who are allergic to the drugs used
- pregnant women
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 |
|---|---|---|
| Bispectral Index Monitorisation (BIS)Standard monitoring was performed with electrocardiography, pulse oximetry and non invasive blood pressure. Additionally, Bispectral index (Aspect Medical Systems, Natica, MA) electrodes were connected to Group B patients | Device | Group B (BIS)=25 patients |
| Ramsey Sedation ScalePropofol administration was done to keep the Ramsey Sedation scale of 3 or 4 | Other | Group R (Ramsey)=25 patients |
Primary outcome
Effects of BIS on oxidative stress
Time frame: one day
The investigators aimed to investigate the effects of anesthesia with monitoring the depth of anesthesia using BIS on oxidative stres by measuring the total oxidant status (TAS) and total antioxidant status (TOS) , propofol consumption, and postoperative recovery during ERCP procedures in this study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: No. There is no plan to share data
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral Index Monitorisation (BIS) and Ramsey Sedation Scale in people with Oxidative Stress, run by Antalya Training and Research Hospital.
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 2 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: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of BIS on oxidative stress (time frame: one day). 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 24 Jan 2017.