Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
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ClinicalTrials.gov Identifier: NCT03219294 |
Recruitment Status :
Completed
First Posted : July 17, 2017
Results First Posted : September 10, 2019
Last Update Posted : September 18, 2019
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Other |
Condition |
Arthropathy of Hip |
Interventions |
Drug: Vecuronium 0.1 mg/kg Drug: Vecuronium 0.2mg/kg |
Enrollment | 116 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Moderate NMB | Deep NMB |
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Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice. Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions. |
Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex. Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2. |
Period Title: Overall Study | ||
Started | 58 | 58 |
Completed | 58 | 58 |
Not Completed | 0 | 0 |
Arm/Group Title | Moderate NMB | Deep NMB | Total | |
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Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice. Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions. |
Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex. Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 58 | 58 | 116 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 58 participants | 58 participants | 116 participants | |
63.1 (6.7) | 62.9 (7.4) | 63 (7.04) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 58 participants | 116 participants | |
Female |
29 50.0%
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30 51.7%
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59 50.9%
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Male |
29 50.0%
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28 48.3%
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57 49.1%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | |
0 | ||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 58 participants | 58 participants | 116 participants |
58 | 58 | 116 |
Name/Title: | Research Coordinator |
Organization: | Maine Medical Center |
Phone: | 2076622862 |
EMail: | richaj3@mmc.org |
Responsible Party: | Craig Curry, Maine Medical Center |
ClinicalTrials.gov Identifier: | NCT03219294 |
Other Study ID Numbers: |
988210-2 |
First Submitted: | July 11, 2017 |
First Posted: | July 17, 2017 |
Results First Submitted: | August 19, 2019 |
Results First Posted: | September 10, 2019 |
Last Update Posted: | September 18, 2019 |