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

NCT03376308 | Completed

• 1 other identifier: VASCULAR DIAMETER
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Withdrawal

Keywords

rocuronium; propofol; pain; withdrawal; venous diameter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The withdrawal movement due to rocuronium

  6 month

Study Arms (2)

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; 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.

Diagnostic Test: Pain Score; Diagnostic Test: Withdrawal movement score; Diagnostic Test: hemodynamic response

Interventions

Pain Score DIAGNOSTIC_TEST

Four poin scala 0=No Pain 1. mild 2. intermediate 3. severe

Group 1; Group 2

Withdrawal movement score DIAGNOSTIC_TEST

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

Group 1; Group 2

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.

Group 1; Group 2

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Training and Research Hospital

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Neurovascular Coupling

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cerebrovascular Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Sinan Yılmaz

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: June 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-11

Locations

TU (1)