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

Pain Clinical Trial

— VDIAMETER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376308
• Other study ID #: VASCULAR DIAMETER
• Status: Completed
• Phase: N/A
• First received: December 13, 2017
• Last updated: December 16, 2017
• Start date: June 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: November 2017
• Source: Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Withdrawal

Intervention

Diagnostic Test:
• Pain Score
Four poin scala 0=No Pain mild intermediate severe
• Withdrawal movement score
Withdrawal movements no movement response movement limited to the wrist movement limited to the elbow/shoulder, generalized movement response.
• 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.

Locations

Country	Name	City	State
Turkey	Adnan Menderes University Training and Research Hospital	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The injection pain due to propofol	Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).	6 month
Secondary	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.	6 month