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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

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).

Condition or disease Intervention/treatment Phase
Arthropathy of Hip Drug: Vecuronium 0.1 mg/kg Drug: Vecuronium 0.2mg/kg Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
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
Official Title: Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
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.
Drug: Vecuronium 0.1 mg/kg
Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.
Other Name: vecuronium bromide

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.
Drug: Vecuronium 0.2mg/kg
Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
Other Name: vecuronium bromide




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219294


Locations
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Craig Curry
Maine Medical Center
Spectrum Medical Group Anesthesiology
Investigators
Principal Investigator: Craig Curry, MD Maine Medical Center/Spectrum Medical Group

Publications:
Responsible Party: Craig Curry, Anesthesiologist, Maine Medical Center
ClinicalTrials.gov Identifier: NCT03219294     History of Changes
Other Study ID Numbers: 988210-2
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Craig Curry, Maine Medical Center:
neuromuscular blockade
sugammadex

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Bromides
Vecuronium Bromide
Anticonvulsants
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action