NCT03219294

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 10, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

July 11, 2017

Results QC Date

August 19, 2019

Last Update Submit

September 9, 2019

Conditions

Arthropathy of Hip

Keywords

neuromuscular blockadesugammadex

Outcome Measures

Primary Outcomes (1)

  • Surgical Conditions

    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 Outcomes (1)

  • Duration of Surgery

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

Study Arms (2)

Moderate Neuromuscular Blockade (NMB)

ACTIVE COMPARATOR

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

Deep NMB

ACTIVE COMPARATOR

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

Interventions

Vecuronium 0.1 mg/kgDRUG

Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.

Also known as: vecuronium bromide
Moderate Neuromuscular Blockade (NMB)
Vecuronium 0.2mg/kgDRUG

Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.

Also known as: vecuronium bromide
Deep NMB

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Related Publications (5)

  • Basad E, Ishaque B, Sturz H, Jerosch J. The anterolateral minimally invasive approach for total hip arthroplasty: technique, pitfalls, and way out. Orthop Clin North Am. 2009 Oct;40(4):473-8, viii. doi: 10.1016/j.ocl.2009.05.001.

    PMID: 19773052BACKGROUND

  • Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.

    PMID: 25935840BACKGROUND

  • Madsen MV, Staehr-Rye AK, Gatke MR, Claudius C. Neuromuscular blockade for optimising surgical conditions during abdominal and gynaecological surgery: a systematic review. Acta Anaesthesiol Scand. 2015 Jan;59(1):1-16. doi: 10.1111/aas.12419. Epub 2014 Oct 19.

    PMID: 25328055BACKGROUND

  • Paton F, Paulden M, Chambers D, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation. Br J Anaesth. 2010 Nov;105(5):558-67. doi: 10.1093/bja/aeq269. Epub 2010 Oct 8.

    PMID: 20935005BACKGROUND

  • Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Craig D, Hunter J, Wilson J, Sculpher M, Woolacott N. Sugammadex for the reversal of muscle relaxation in general anaesthesia: a systematic review and economic assessment. Health Technol Assess. 2010 Jul;14(39):1-211. doi: 10.3310/hta14390.

    PMID: 20688009BACKGROUND

MeSH Terms

Interventions

Vecuronium Bromide

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Research Coordinator
Organization
Maine Medical Center
richaj3@mmc.org
2076622862

Study Officials

  • Craig Curry, MD

    Maine Medical Center/Spectrum Medical Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The anesthesiologist will NOT be blinded, but the orthopedic surgeon performing the hip replacement surgery will be.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 17, 2017

Study Start

May 1, 2017

Primary Completion

April 30, 2018

Study Completion

May 1, 2018

Last Updated

September 18, 2019

Results First Posted

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)