- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03376308
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Aydın, 칠면조, 09100
- Adnan Menderes University Training and Research Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 크로스오버
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
Four poin scala 0=No Pain
Withdrawal movements
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. |
Four poin scala 0=No Pain
Withdrawal movements
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The injection pain due to propofol
기간: 6 month
|
Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
|
6 month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The withdrawal movement due to rocuronium
기간: 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.
|
6 month
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- VASCULAR DIAMETER
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
통증에 대한 임상 시험
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
Pain Score에 대한 임상 시험
-
The Hospital for Sick ChildrenUniversity Health Network, Toronto; University of British Columbia; Centre for Addiction... 그리고 다른 협력자들모병
-
University of FloridaAgency for Healthcare Research and Quality (AHRQ)완전한
-
The Defense and Veterans Brain Injury Center완전한