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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
Sponsor:
Collaborators:
Maine Medical Center
Spectrum Medical Group Anesthesiology
Information provided by (Responsible Party):
Craig Curry, Maine Medical Center

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 58 participants 58 participants 116 participants
Female
29
  50.0%
30
  51.7%
59
  50.9%
Male
29
  50.0%
28
  48.3%
57
  49.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants 58 participants 116 participants
58 58 116
1.Primary Outcome
Title Surgical Conditions
Hide Description The surgeon graded the overall surgical conditions on a 5 point Likert scale, that was taken into account along with requests for additional muscle relaxation. The Likert scale went from 1 (extremely poor conditions: muscles resistant to retraction and obscure view, implant difficult to insert into socket, requires assist) to 5 (optimal conditions: muscles relaxed, excellent view, implant easy to insert).
Time Frame Through study completion, an average of 24 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Moderate NMB Deep NMB
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 58 58
Measure Type: Count of Participants
Unit of Measure: Participants
Extremely Poor Conditions
1
   1.7%
2
   3.4%
Poor Conditions
11
  19.0%
10
  17.2%
Acceptable Conditions
30
  51.7%
29
  50.0%
Good Conditions
15
  25.9%
15
  25.9%
Optimal Conditions
1
   1.7%
2
   3.4%
2.Secondary Outcome
Title Duration of Surgery
Hide Description Time from incision to joint reduction
Time Frame Through study completion, an average of 24 hours for each patient and up to one year for the whole study.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Moderate NMB Deep NMB
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 58 58
Mean (Standard Deviation)
Unit of Measure: minutes
32.6  (1.2) 33.8  (1.2)
Time Frame Patients were monitored for the duration of their surgical case and time in the post-anesthesia care unit until discharge from the hospital, usually 24 hours, and had a post-surgical follow-up several weeks after discharge.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moderate NMB Deep NMB
Hide Arm/Group Description

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.

All-Cause Mortality
Moderate NMB Deep NMB
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/58 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Moderate NMB Deep NMB
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/58 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Moderate NMB Deep NMB
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/58 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Research Coordinator
Organization: Maine Medical Center
Phone: 2076622862
EMail: richaj3@mmc.org
Layout table for additonal information
Responsible Party: Craig Curry, Maine Medical Center
ClinicalTrials.gov Identifier: NCT03219294     History of Changes
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