The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics
1 other identifier
interventional
58
1 country
1
Brief Summary
This study is a randomized, controlled, double-blinded, and parallel design study. A total 58 patients were randomized to receive a deep block or a moderate block scheduled for elective robot assisted laparoscopic radical prostatectomy. Intraoperative peak inspiratory pressure and plateau pressure are assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedStudy Start
First participant enrolled
November 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedDecember 9, 2021
December 1, 2021
9 months
November 21, 2019
December 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Peak inspiratory pressure
measured through ventilator
until 1 hour after pneumoperitoneum
Secondary Outcomes (5)
plateau pressure
until 1 hour after pneumoperitoneum
dynamic lung compliance
until 1 hour after pneumoperitoneum
static lung compliance
until 1 hour after pneumoperitoneum
5-point surgical rating scale
1 min at the end of surgery
Postoperative pulmonary complications
postoperative 30 min
Study Arms (2)
Moderate block
ACTIVE COMPARATOR5-10mg rocuronium is administered to maintain train-of-four count 1-2. At the end of surgery, sugammadex 2mg/kg is administered IV for reversal of neuromuscular block.
Deep block
EXPERIMENTAL5-10mg rocuronium is administered to maintain train-of-four count 0, and post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
Interventions
Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.
Eligibility Criteria
You may qualify if:
- Patients who undergo elective robot assisted radical prostatectomy,
- American Society of Anesthesiologists grade 1 or 2
You may not qualify if:
- Refuse to participate to the study
- history of neuromuscular diseases
- known allergy to rocuronium, sugammadex
- patients scheduled for intensive care unit transfer
- Body Mass Index \> 30 kg/m2
- Severe renal function impairment
- Moderete or severe obstructive/restrictive lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Chang-Hoon Koo
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
November 21, 2019
First Posted
November 22, 2019
Study Start
November 22, 2019
Primary Completion
August 30, 2020
Study Completion
June 30, 2021
Last Updated
December 9, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share