PainVDIAMETERNCT03376308
Evaluation of the Effect of Venous Diameter Measurement by Ultrasonography on Pain and Withdrawal Response
An observational study of Pain and Withdrawal, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
During general anesthesia, intravenous (IV) medications can disrupt the patient's comfort by causing a pain sensation or a withdrawal response in the heart. Propofol and rocuronium are among the most common causes of this condition. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Withdrawal
- What is being tested?
- Pain Score, Withdrawal movement score and hemodynamic response
- Type of treatment
- Injection or infusion
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 1 Oct 2017
- Phase
- Observational
- 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 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study was conducted on 145 patients aged 17- 70 years of ASA (American Society of Anesthesiologists) physical status I- II who were to undergo various elective operations. None of the patients was premedicated before the operation. Venous diameter measurements were performed in preoperative room via USG.The patients were monitored with three derivation electrocardiogram, non- invasive arterial pressure, and pulse oximeter.
Who may be able to join
- 18- 70 years of ASA (American society of anesthesiology) physical status I- II who were to undergo various elective operations
Who cannot join
- Rheumatologic disease Peripheric vascular disease Vasculitis Patients with chronic pain syndrome, Patients with neurologic deficits, Patients with thrombophlebitis, Patients with difficult venous access, Patients with allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University Training and Research Hospital
Aydin, 09100
About this study
During general anesthesia, intravenous (IV) medications can disrupt the patient's comfort by causing a pain sensation or a withdrawal response in the heart. Propofol and rocuronium are among the most common causes of this condition.
In recent years, the use of ultrasonography (USG) in anesthesia has become widespread with the rapid advancement of technology. The use of the patient's head is a non invasive method.
This study is aimed to evaluate whether the size of the venous diameter assessed by ultrasonography in our study is an effect on pain and withdrawal response after drug injections.
Read the detailed description
The study was conducted in patients who underwent surgical procedures under general anesthesia by obtaining consent from the Adnan Menderes University Medical Faculty Ethics Board and written consent from the patients and then being admitted to the ASA I-II age group 18-70 years of age.
Patients with peripheric vascular disease, vasculitis, rheumatologic disease, non-cooperative, under the age of 18 and over 70, ASA III and above, allergic to general anesthetic agents and refusing to participate in the study were excluded from the study.
- Conditions
- Pain, Withdrawal
- Being tested
- Pain Score, Withdrawal movement score, hemodynamic response
- Keywords
- rocuronium, propofol, pain, withdrawal, venous diameter
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain ScoreDiagnostic test
Four poin scala 0=No Pain
- mild
- intermediate
- severe
Withdrawal movement scoreDiagnostic test
Withdrawal movements
- no movement response
- movement limited to the wrist
- movement limited to the elbow/shoulder,
- generalized movement response.
hemodynamic responseDiagnostic test
Hemodynamic data were recorded in the patients taken in the operation room. (T0). Hemodynamic values (T1) measured 1 minute after administration of intravenous propofol were recorded. Hemodynamic values (T2) measured 1 minute after administration of intravenous rocuronium were recorded. Hemodynamic values (T3) measured 1 minute after administration of endotracheal intubation were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Venous diameter measurements were made via the USG in the hand dorsum. Transverse venous diameter ≤2mm was defined group 1.
Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded. Receives: Diagnostic Test: Pain Score; Diagnostic Test: Withdrawal movement score; Diagnostic Test: hemodynamic response | |
| Group 2 | Venous diameter measurements were made via the USG in the hand dorsum.Transverse venous diameter >2mm was defined group 2.Anesthesia induction drugs were all treated in the same order and dose.
Pain score, withdrawal movement score and hemodynamic response was recorded. Receives: Diagnostic Test: Pain Score; Diagnostic Test: Withdrawal movement score; Diagnostic Test: hemodynamic response |
What is being measured
The primary outcome is the main question the study is designed to answer.
The injection pain due to propofol
Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
Measured: 6 month
Secondary outcomes (1)
The withdrawal movement due to rocuronium
Withdrawal movements are scored as follows: (a) no movement response, (b) movement limited to the wrist, (c)movement limited to the elbow/shoulder, or (d) generalized movement response.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Jun 2017
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SİNAN YILMAZ, Aydin Adnan Menderes University
- Investigators
- Sinan Yılmaz, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376308
- Sponsor's protocol ID
- VASCULAR DIAMETER
- Acronym
- VDIAMETER
- Status last verified
- Nov 2017
- First submitted
- 13 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Venous Diameter Measurement by Ultrasonography on Pain and Withdrawal Response
- ClinicalTrials.gov ID
- NCT03376308
- Acronym / sponsor ID
- VDIAMETER / VASCULAR DIAMETER
- Conditions
- Pain, Withdrawal
- Keywords
- rocuronium, propofol, pain, withdrawal, venous diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 18 Dec 2017 (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.
During general anesthesia, intravenous (IV) medications can disrupt the patient's comfort by causing a pain sensation or a withdrawal response in the heart. Propofol and rocuronium are among the most common causes of this condition.
In recent years, the use of ultrasonography (USG) in anesthesia has become widespread with the rapid advancement of technology. The use of the patient's head is a non invasive method.
This study is aimed to evaluate whether the size of the venous diameter assessed by ultrasonography in our study is an effect on pain and withdrawal response after drug injections.
Detailed description
The study was conducted in patients who underwent surgical procedures under general anesthesia by obtaining consent from the Adnan Menderes University Medical Faculty Ethics Board and written consent from the patients and then being admitted to the ASA I-II age group 18-70 years of age.
Patients with peripheric vascular disease, vasculitis, rheumatologic disease, non-cooperative, under the age of 18 and over 70, ASA III and above, allergic to general anesthetic agents and refusing to participate in the study were excluded from the study.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Pain Score, Diagnostic Test: Withdrawal movement score, Diagnostic Test: hemodynamic responseVenous diameter measurements were made via the USG in the hand dorsum. Transverse venous diameter ≤2mm was defined group 1. Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded. |
| Group 2 | – | Diagnostic Test: Pain Score, Diagnostic Test: Withdrawal movement score, Diagnostic Test: hemodynamic responseVenous diameter measurements were made via the USG in the hand dorsum.Transverse venous diameter >2mm was defined group 2.Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study was conducted on 145 patients aged 17- 70 years of ASA (American Society of Anesthesiologists) physical status I- II who were to undergo various elective operations. None of the patients was premedicated before the operation. Venous diameter measurements were performed in preoperative room via USG.The patients were monitored with three derivation electrocardiogram, non- invasive arterial pressure, and pulse oximeter.
Key inclusion criteria (1 listed)
- 18- 70 years of ASA (American society of anesthesiology) physical status I- II who were to undergo various elective operations
Key exclusion criteria (1 listed)
- Rheumatologic disease Peripheric vascular disease Vasculitis Patients with chronic pain syndrome, Patients with neurologic deficits, Patients with thrombophlebitis, Patients with difficult venous access, Patients with allergy
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 |
|---|---|---|
| Pain ScoreFour poin scala 0=No Pain 1. mild 2. intermediate 3. severe | Diagnostic test | Group 1, Group 2 |
| Withdrawal movement scoreWithdrawal movements 1. no movement response 2. movement limited to the wrist 3. movement limited to the elbow/shoulder, 4. generalized movement response. | Diagnostic test | Group 1, Group 2 |
| hemodynamic responseHemodynamic data were recorded in the patients taken in the operation room. (T0). Hemodynamic values (T1) measured 1 minute after administration of intravenous propofol were recorded. Hemodynamic values (T2) measured 1 minute after administration of intravenous rocuronium were recorded. Hemodynamic values (T3) measured 1 minute after administration of endotracheal intubation were recorded. | Diagnostic test | Group 1, Group 2 |
Primary outcome
The injection pain due to propofol
Time frame: 6 month
Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
1 secondary outcome
The withdrawal movement due to rocuronium
Time frame: 6 month
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 19 Dec 2017.
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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.
Sinan Yılmaz principal investigator
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Withdrawal, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 1 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 19 Dec 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 Turkey (Türkiye). 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. 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?
The injection pain due to propofol (time frame: 6 month). 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 19 Dec 2017.