Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Effect of Venous Diameter Measurement by Ultrasonography on Pain and Withdrawal Response (VDIAMETER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376308
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
SİNAN YILMAZ, Aydin Adnan Menderes University

Brief 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.

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.


Condition or disease Intervention/treatment
Pain Withdrawal Diagnostic Test: Pain Score Diagnostic Test: Withdrawal movement score Diagnostic Test: hemodynamic response

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Evaluation of the Effect of Venous Diameter Measurement by Ultrasonography on Pain and Withdrawal Response
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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.

Diagnostic Test: Pain Score

Four poin scala 0=No Pain

  1. mild
  2. intermediate
  3. severe

Diagnostic Test: Withdrawal movement score

Withdrawal movements

  1. no movement response
  2. movement limited to the wrist
  3. movement limited to the elbow/shoulder,
  4. generalized movement response.

Diagnostic Test: hemodynamic response
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.

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.

Diagnostic Test: Pain Score

Four poin scala 0=No Pain

  1. mild
  2. intermediate
  3. severe

Diagnostic Test: Withdrawal movement score

Withdrawal movements

  1. no movement response
  2. movement limited to the wrist
  3. movement limited to the elbow/shoulder,
  4. generalized movement response.

Diagnostic Test: hemodynamic response
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. The withdrawal movement due to rocuronium [ Time Frame: 6 month ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

18- 70 years of ASA (American society of anesthesiology) physical status I- II who were to undergo various elective operations

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376308


Locations
Layout table for location information
Turkey
Adnan Menderes University Training and Research Hospital
Aydın, Turkey, 09100
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
Layout table for investigator information
Principal Investigator: Sinan Yılmaz Aydin Adnan Menderes University
Layout table for additonal information
Responsible Party: SİNAN YILMAZ, Principal Investigator, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03376308    
Other Study ID Numbers: VASCULAR DIAMETER
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SİNAN YILMAZ, Aydin Adnan Menderes University:
rocuronium
propofol
pain
withdrawal
venous diameter