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

NCT ID: NCT03376308

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2017-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Withdrawal

Keywords

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rocuronium propofol pain withdrawal venous diameter

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Pain Score

Intervention Type DIAGNOSTIC_TEST

Four poin scala 0=No Pain

1. mild
2. intermediate
3. severe

Withdrawal movement score

Intervention Type 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.

hemodynamic response

Intervention Type 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 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.

Pain Score

Intervention Type DIAGNOSTIC_TEST

Four poin scala 0=No Pain

1. mild
2. intermediate
3. severe

Withdrawal movement score

Intervention Type 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.

hemodynamic response

Intervention Type 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.

Interventions

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Pain Score

Four poin scala 0=No Pain

1. mild
2. intermediate
3. severe

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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SİNAN YILMAZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sinan Yılmaz

Role: PRINCIPAL_INVESTIGATOR

Aydin Adnan Menderes University

Locations

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Adnan Menderes University Training and Research Hospital

Aydin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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VASCULAR DIAMETER

Identifier Type: -

Identifier Source: org_study_id