- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02580188
The Effect of Deep Neuromuscular Block on Surgical Condition During Laparoscopic Colorectal Surgery (DEEPCOL)
2019년 3월 12일 업데이트: BON WOOK KOO, Seoul National University Bundang Hospital
This study is a randomized, controlled, double-blinded, and parallel design study.
A total 96 patients were randomized to receive a deep block or a moderate block scheduled for elective laparoscopic colorectal surgery.
Investigators estimated the proportion of intra-abdominal pressure(IAP) alarm and surgical rating score.
연구 개요
상세 설명
Patients >18 years of age with an america society of anesthesiologist classification of I or II who were scheduled to undergo elective laparoscopic colorectal surgery were included.
The exclusion criteria were a history of neuromuscular, renal, or hepatic disease, a history of low abdominal surgery; treatment with drugs known to interfere with neuromuscular function.
Patients were randomised to either the moderate or deep neuromuscular blockade group using Random Allocation Software (version 1.0).
Premedication with intravenous midazolam at 0.03 mg/kg was performed in the reception area.
In the operating room, routine monitoring was performed, including electrocardiography, non-invasive arterial pressure measurements, and pulse oximetry.
Additionally, acceleromyography was applied to monitor the response of the corrugator supercilii muscle.
Neuromuscular management and monitoring were performed according to the Good Clinical Research Practice guidelines.
After the induction of anaesthesia with propofol and remifentanil using target-controlled infusers and before rocuronium administration, the TOF-Watch-SX was calibrated and stabilised; a 50-Hz tetanic stimulation was applied for 5 s, the TOF-Watch-SX was calibrated, and a series of train-of-four (TOF) measurements were documented for >2 min until a stable baseline was obtained (<5% variation in the TOF ratios).
Next, intravenous rocuronium at 0.6 mg/kg was administered, and tracheal intubation was performed after confirmation of relaxation.
Anesthesia was maintained with desflurane and target-controlled infusion of remifentanil while monitoring the bispectral index.
A continuous dose of intravenous rocuronium (10-60 mg/hr) was used to maintain moderate (TOF count of 1 or 2) or deep (post-tetanic count [PTC] of 1 or 2) neuromuscular blockade.
The IAP alarm(IAP>15mmHg) rate were checked.
Any movement during the operation as reported by the surgeon or anaesthesiologist was recorded.
At the end of the operation, the surgeon rated the surgical condition on a 5-point scale.
Patients in the moderate group were reversed with neostigmine at 50 µg/kg and glycopyrrolate at 10 µg/kg at a TOF count of 1 or 2, and patients in the deep group were reversed with intravenous sugammadex at 4 mg/kg at PTC of 1 or 2. The time from administration of the reversal agents to a TOF ratio of 0.9 was recorded.
Postoperative pain and opioid consumption were evaluated at 24, 48h postoperatively.
Postoperative nausea and/or vomiting, dry mouth, were also evaluated at the same time points.
연구 유형
중재적
등록 (실제)
70
단계
- 4단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- American Society of Anesthesiologists grade 1 or 2
- Scheduled for elective laparoscopic Colorectal surgery
Exclusion Criteria:
- Severe respiratory or cardiac disease
- Severe hepatic or renal function impairment
- On medications affecting neuromuscular function
- Known allergy to the drugs to be used
- Pregnant
- Malignant hyperthernia
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Moderate block
Maintenance dose of 0.15-0.3
mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block).
At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
|
|
|
실험적: Deep block
Maintenance dose of 0.4-0.9
mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
|
Maintenance dose of 0.4-0.9
mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg
기간: intraoperative, an averrage of 3 hour
|
Intra-abdominal pressure was maintained at 12 mmHg during pneumoperitoneum(using the carbon dioxide gas insufflation) and the pressure alarm for IAP was set at < 15 mmHg. Intra-abdominal pressure is measured in a separate machine connected to a carbon dioxide gas injection line. |
intraoperative, an averrage of 3 hour
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
기간: 24hr after end of operation
|
Postoperative pain is controlled by IV patient controlled analgesia using fentanyl.
If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.
|
24hr after end of operation
|
|
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
기간: 48hr after end of operation
|
Postoperative pain is controlled by IV patient controlled analgesia using fentanyl.
If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.
|
48hr after end of operation
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Ah-Young Oh, MD.,Ph.D., Seoul National Univ. Bundang Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 3월 24일
기본 완료 (실제)
2016년 6월 16일
연구 완료 (실제)
2016년 6월 18일
연구 등록 날짜
최초 제출
2015년 9월 30일
QC 기준을 충족하는 최초 제출
2015년 10월 19일
처음 게시됨 (추정)
2015년 10월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 3월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 12일
마지막으로 확인됨
2019년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- DNMBC-SNUBH
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .