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Completed

NCT Number: NCT03376308

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Withdrawal

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Adnan Menderes University Training and Research Hospital

Aydin, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain Score

Diagnostic Test

Four poin scala 0=No Pain

  • mild
  • intermediate
  • severe

Withdrawal movement score

Diagnostic Test

Withdrawal movements

  • no movement response
  • movement limited to the wrist
  • movement limited to the elbow/shoulder,
  • generalized movement response.

hemodynamic response

Diagnostic 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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Acronym: VDIAMETER

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2017
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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