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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Withdrawal
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Adnan Menderes University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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; mild; intermediate; severe; Diagnostic test: Withdrawal movement score; Withdrawal movements; no movement response; movement limited to the wrist; movement limited to the elbow/shoulder,; 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; mild; intermediate; severe; Diagnostic test: Withdrawal movement score; Withdrawal movements; no movement response; movement limited to the wrist; movement limited to the elbow/shoulder,; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: pain; propofol; rocuronium; withdrawal; venous diameter
• Other Study ID Numbers: VASCULAR DIAMETER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No