Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization).
This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%.
The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.
연구 개요
상세 설명
From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.
Patients will perform pulmonary function tests (PFTs):
- the day ahead of surgery (for elegibility and training)
- 60 minutes before surgery
- 10 minutes after extubation
- 5 minutes after sugammadex or placebo administration
- 20 minutes after sugammadex or placebo administration.
The following parameters will be evaluated and compared between the 2 groups:
- Maximal Inspiratory Pressure (MIP)
- Maximal Expiratory Pressure (MEP)
- Forced Expiratory Volume in the first Second (FEV1)
- Forced Vital Capacity (FVC)
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50)
- PaO2, PaCO2, pH
- heart rate, blood pressure and respiratory rate
Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Milan, 이탈리아
- Fondazione IRCCS Istituto Nazionale dei Tumori
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients undergoing major abdominal surgery
- age between 18 and 70 years
- ASA class 1 or 2
- patients scheduled for blended anesthesia (epidural + general anesthesia)
- patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges).
Exclusion Criteria:
- known or suspected respiratory, cardiovascular or neuromuscular disease
- renal or hepatic failure
- known or suspected allergies to drugs used in the study
- risk for malignant hyperthermia
- pregnancy
- diagnosed depressive disorder
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 슈가마덱스
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sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v.
(0,1 ml/kg)
다른 이름들:
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위약 비교기: Sodium chloride solution
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Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
기간: 10 minutes after surgery and 5 minutes later
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10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex
기간: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex
기간: 10 minutes after surgery and 5 minutes later
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10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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Forced Vital Capacity (FVC) changes after placebo or sugammadex
기간: 10 minutes after surgery and 5 minutes later
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10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex
기간: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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|
Hemogasanalysis parameters changes after placebo or sugammadex
기간: 10 minutes after surgery and 5 minutes later
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10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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Swallow ability changes after placebo or sugammadex
기간: 10 minutes after surgery and 5 minutes later
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10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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공동 작업자 및 조사자
수사관
- 연구 책임자: Federico Piccioni, MD, Fondazione IRCCS Istituto Nazionale dei tumori - Milan
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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