Awakeness, PainRBNCT03650283
Relation Between PRST Score, Skin Conductance and BIS
A study testing monitoring in people with Awakeness, Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital.
Trial summary
Determine the relation between PRST (pressure, rate, sweating, tears) score, skin conductance (SC) and Bispectral index (BIS) values during anesthesia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Awakeness, Pain
- What is being tested?
- monitoring
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2019to 31 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minor elective surgery
- General anaesthesia
Who cannot join
- autonomic neuropathy
- presence of a pacemaker
- medication with anticholinergic drugs
- use of ketamine, clonidine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Relation Between PRST Score, Skin Conductance and BIS Values During Anesthesia
Determine the relation between PRST (pressure, rate, sweating, tears) score, skin conductance (SC) and Bispectral index (BIS) values during anesthesia
Read the detailed description
Probability of >0 points in the PRST as a function of BIS and number of fluctuations in mean skin conductance (NFSC) will be recorded during the anesthesia.
- Conditions
- Awakeness, Pain
- Being tested
- monitoring
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoringOther
The bispectral index (BIS) and skin conductance (SC) monitors will be connected when patient will be positioned on the operating table. A BIS value greater than 60 will be considered an indicator of light anaesthesia. The SC monitoring will be achieved using the MEDSTORM AS 2005 monitor. Number of fluctuations in mean skin conductance (NFSC) of >0.1 s-1 in a period of 15 s might be counted as a significant change and indicates an increase in the sympathetic outflow. General anaesthesia will be performed and laryngeal mask will be inserted. Blood pressure, heart rate, BIS, SC, and PRST (pressure, rate, sweating, tears) score will be recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between NFSC, PRST and BIS
Correlation between NFSC-PRST and, BIS-PRST will be assessed.
Measured: anesthesia induction (while giving induction agent to the patient), surgical incision (when the surgeon makes the first incision), extubation (when LMA is removed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start4 Mar 2019 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awakeness, PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bahar SAKIZCI UYAR, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650283
- Sponsor's protocol ID
- 40/19
- Acronym
- RB
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between PRST Score, Skin Conductance and BIS Values During Anesthesia
- ClinicalTrials.gov ID
- NCT03650283
- Acronym / sponsor ID
- RB / 40/19
- Conditions
- Awakeness, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 4 Mar 2019 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 28 Aug 2018 (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.
Determine the relation between PRST (pressure, rate, sweating, tears) score, skin conductance (SC) and Bispectral index (BIS) values during anesthesia
Detailed description
Probability of >0 points in the PRST as a function of BIS and number of fluctuations in mean skin conductance (NFSC) will be recorded during the anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Minor elective surgery
- General anaesthesia
Key exclusion criteria (4 listed)
- autonomic neuropathy
- presence of a pacemaker
- medication with anticholinergic drugs
- use of ketamine, clonidine
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 |
|---|---|---|
| monitoringThe bispectral index (BIS) and skin conductance (SC) monitors will be connected when patient will be positioned on the operating table. A BIS value greater than 60 will be considered an indicator of light anaesthesia. The SC monitoring will be achieved using the MEDSTORM AS 2005 monitor. Number of fluctuations in mean skin conductance (NFSC) of >0.1 s-1 in a period of 15 s might be counted as a significant change and indicates an increase in the sympathetic outflow. General anaesthesia will be performed and laryngeal mask will be inserted. Blood pressure, heart rate, BIS, SC, and PRST (pressure, rate, sweating, tears) score will be recorded. | Other | – |
Primary outcome
Correlation between NFSC, PRST and BIS
Time frame: anesthesia induction (while giving induction agent to the patient), surgical incision (when the surgeon makes the first incision), extubation (when LMA is removed)
Correlation between NFSC-PRST and, BIS-PRST will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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.
Questions about this trial
What is this clinical trial studying?
A study testing monitoring in people with Awakeness, Pain, run by Diskapi Yildirim Beyazit Education 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: status not confirmed, as of the sponsor's last update on 11 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahar SAKIZCI UYAR (5057000240, drsakizciuyar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between NFSC, PRST and BIS (time frame: anesthesia induction (while giving induction agent to the patient), surgical incision (when the surgeon makes the first incision), extubation (when LMA is removed)). 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 11 Feb 2019.