견관절경술을 받은 환자의 마취방법에 따른 수술 후 회복의 질 비교
어깨 관절 경술을 받는 환자의 수술 후 마취 방법에 따른 회복 품질 비교: 전신 마취 하 통증 조절을 위한 상완 신경총 차단과 진정제 하에서 수술 차단을 위한 상완 신경총 차단
The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used:
- general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia
- regional anesthesia (brachial plexus block) with intraoperative sedation.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Jongno-gu
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Seoul, Jongno-gu, 대한민국, 03080
- Seoul National University Hospital
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients of age 19 years and above, scheduled for shoulder arthroscopic surgery
Exclusion Criteria:
- emergency operation
- inflammation or infection at the site of nerve block administration
- inability to perform the quality of recovery questionnaire due to dementia or delirium
- severe lung disease (e.g. chronic obstructive pulmonary disease or interstitial lung disease)
- contraindication to brachial plexus block
- history of hypersensitivity or side effect to ropivacaine
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: General anesthesia
The patient undergoes shoulder arthroscopy under general anesthesia after receiving a preoperative brachial plexus block for intra- and postoperative analgesia. |
General anesthesia with propofol, fentanyl and rocuronium for induction, and with sevoflurane for maintenance. Brachial plexus block with 0.5% ropivacaine for intra- and postoperative analgesia. |
|
실험적: Brachial plexus block
The patient undergoes shoulder arthroscopy under brachial plexus block and intraoperative sedation with remimazolam or propofol. |
Interscalene brachial plexus block with 0.75% ropivacaine. Intraoperative sedation with remimazolam or propofol. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of recovery (QoR-15) at 48 hours post-surgery
기간: at 48 hours post-surgery
|
Quality of recovery (QoR-15) at 48 hours post-surgery (0-150) |
at 48 hours post-surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Antiemetic administration
기간: rom end of surgery up to 48 hours post-surgery
|
Antiemetic administration from end of surgery up to 48 hours post-surgery |
rom end of surgery up to 48 hours post-surgery
|
|
Baseline hemidiagphramatic paralysis
기간: On the day of surgery, before the operation
|
Baseline hemidiagphramatic paralysis |
On the day of surgery, before the operation
|
|
Postoperative hemidiagphramatic paralysis
기간: Immediately after surgery
|
Postoperative hemidiagphramatic paralysis |
Immediately after surgery
|
|
Quality of recovery (QoR-15) on the day before surgery
기간: on the day before surgery
|
Quality of recovery (QoR-15) on the day before surgery (0-150) |
on the day before surgery
|
|
Quality of recovery (QoR-15) 24 hours post-surgery
기간: at 24 hours post-surgery
|
Quality of recovery (QoR-15) 24 hours post-surgery (0-150) |
at 24 hours post-surgery
|
|
Postoperative pain 1 hour post-surgery
기간: at 1 hour post-surgery
|
Postoperative pain 1 hour post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 1 hour post-surgery
|
|
Postoperative pain 6 hours post-surgery
기간: at 6 hours post-surgery
|
Postoperative pain 6 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 6 hours post-surgery
|
|
Postoperative pain 12 hours post-surgery
기간: at 12 hours post-surgery
|
Postoperative pain 12 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 12 hours post-surgery
|
|
Postoperative pain 24 hours post-surgery
기간: at 24 hours post-surgery
|
Postoperative pain 24 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 24 hours post-surgery
|
|
Postoperative pain 48 hours post-surgery
기간: at 48 hours post-surgery
|
Postoperative pain 48 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 48 hours post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery
기간: at 1 hour post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery |
at 1 hour post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery
기간: at 6 hours post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery |
at 6 hours post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery
기간: at 12 hours post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery |
at 12 hours post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery
기간: at 24 hours post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery |
at 24 hours post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery
기간: at 48 hours post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery |
at 48 hours post-surgery
|
|
Rescue opioid analgesic administration
기간: from end of surgery up to 48 hours post-surgery
|
Rescue opioid analgesic administration from end of surgery up to 48 hours post-surgery (morphine milligram equivalent, MME) |
from end of surgery up to 48 hours post-surgery
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hansol Kim, MD, Seoul National University Hospital
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
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