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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
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
Maine Medical Center
Spectrum Medical Group Anesthesiology
Information provided by (Responsible Party):
Craig Curry, Maine Medical Center

Tracking Information
First Submitted Date  ICMJE July 11, 2017
First Posted Date  ICMJE July 17, 2017
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
Surgical conditions [ Time Frame: Through study completion, an average of 24 hours for each patient and up to one year for the whole study. ]
The surgeon will grade the overall surgical conditions on a 5 point Likert scale, that will be taken into account along with requests for additional muscle relaxation.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03219294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
Duration of surgery [ Time Frame: Through study completion, an average of 24 hours for each patient and up to one year for the whole study. ]
Time from incision to joint reduction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
Official Title  ICMJE Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
Brief Summary During many surgeries, increased muscle tension makes it harder for the surgeon to expose the site of surgery and work within the incision. Neuromuscular blockade (NMB) drugs such as Vecuronium bind to neurotransmitter (acetyl choline) receptors at the neuromuscular junction, blocking their action and producing muscle relaxation. This muscle relaxation allows easier retraction of muscle tissues and manipulation of structures in the wound. Improved surgical conditions are likely to result in improved patient outcomes. While increased depths of NMB have been shown to optimize surgical conditions during intra-abdominal and retroperitoneal procedures, the impact of NMB depth has not been reported for orthopedic surgeries.1 To address this, we propose to study the effect of NMB depth on surgical conditions during total hip replacement (THR).
Detailed Description

Specific Aims

  1. Assess difference in surgical conditions between moderate and deep NMB groups. Enrolled patients will be randomized to receive moderate (n=58) or deep (n=58) NMB. Difference in surgical conditions will be evaluated by:

    1. The number of requests from the surgeon for additional relaxation (NMB) during the procedure. At any time during the operation if the surgeon feels the muscle tension is interfering with ease of operation he will ask for additional muscle relaxation. If the patient is moderately relaxed they will be converted to deep relaxation with additional muscle relaxants. If they are already deeply relaxed no additional relaxants will be administered (as is our current practice). All requests will be recorded.
    2. Rating by the surgeon after each surgery using an internally developed satisfaction scale. The scale was developed by modifying a scale used in a previous study of muscle relaxation in intra-abdominal surgery1 to specify two key elements identified by our surgeon: ease of muscle retraction and femur manipulation.
  2. Assess the impact of deep vs moderate NMB on time of surgery, measured from the time of incision to joint reduction.

SIGNIFICANCE If we identify improved surgical conditions with deeper relaxation we will incorporate deep NMB into our routine anesthesia practice for THR.

Vecuronium will be used as NMB drug in all study patients; this agent is currently used in over 90% of THR cases at Maine Medical Center (MMC). As is currently routine Vecuronium will be given after initiation of general anesthesia with propofol to facilitate intubation and further doses of Vecuronium will be given throughout the case as noted below to maintain NMB at the desired depth until the femoral implant is reduced. After the intubating dose of Vecuronium, NMB depth will be monitored every 5 minutes and dosing will be adjusted as needed to maintain a constant depth of NMB according to our current routine practice.

Group 1: Moderate NMB: Intubating dose of Vecuronium of 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 train of four (TOF) contractions. Redosing in this manner is a current clinical practice.

Group 2: Deep NMB: Intubating dose of Vecuronium of 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.

The surgeon may request additional relaxation at anytime for inadequate surgical conditions thought to be related to muscle tension. All requests will be recorded. Patients in the moderate NMB group will receive additional doses of vecuronium to achieve deep NMB (PTC of 1- 2). In the deep NMB group with PTC of 1-2, a saline dose without NMB will be given.

NMB reversal Sugammadex will be given for reversal of NMB after the prosthesis has been reduced, using routine dosing of 2 mg/kg for the moderate group and 4 mg/kg for the deep group, per package insert by Merck.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
The anesthesiologist will NOT be blinded, but the orthopedic surgeon performing the hip replacement surgery will be.
Primary Purpose: Other
Condition  ICMJE Arthropathy of Hip
Intervention  ICMJE
  • Drug: Vecuronium 0.1 mg/kg
    Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.
    Other Name: vecuronium bromide
  • Drug: Vecuronium 0.2mg/kg
    Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
    Other Name: vecuronium bromide
Study Arms  ICMJE
  • Active Comparator: Moderate NMB
    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.
    Intervention: Drug: Vecuronium 0.1 mg/kg
  • Active Comparator: Deep NMB
    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.
    Intervention: Drug: Vecuronium 0.2mg/kg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2017)
116
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) Physical status 1-3
  • age 50-75
  • English speaking
  • able to provide informed consent
  • BMI equal to less than 30
  • non-emergent THR by anterolateral minimally invasive non-cemented total hip arthroplasty

Exclusion Criteria:

  • Revision surgery
  • Bilateral THR
  • ASA 4+
  • age less than 50 or greater than 75
  • BMI greater than 30
  • unable to provide informed consent
  • women taking oral contraceptives (Sugammadex used for reversal interferes with their efficacy
  • contraindications to general inhalation anesthesia (such as malignant hyperthermia)
  • contraindications to NMB (known allergy to NMB)
  • chronic kidney disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03219294
Other Study ID Numbers  ICMJE 988210-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Craig Curry, Maine Medical Center
Study Sponsor  ICMJE Craig Curry
Collaborators  ICMJE
  • Maine Medical Center
  • Spectrum Medical Group Anesthesiology
Investigators  ICMJE
Principal Investigator: Craig Curry, MD Maine Medical Center/Spectrum Medical Group
PRS Account Maine Medical Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP