Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?

September 9, 2019 updated by: Craig Curry
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Moderate Neuromuscular Blockade (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 train-of-four (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 Names:
  • 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 Maine Medical Center (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 Names:
  • vecuronium bromide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Conditions
Time Frame: Through study completion, an average of 24 hours.
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).
Through study completion, an average of 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 24 hours for each patient and up to one year for the whole study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Craig Curry

Collaborators

MaineHealth
Spectrum Medical Group Anesthesiology

Investigators

  • Principal Investigator: Craig Curry, MD, Maine Medical Center/Spectrum Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ACTUAL)

April 30, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (ACTUAL)

July 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 988210-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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