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Effect of NMBA on Surgical Conditions in THR

NCT03369782 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-03-12

No results posted yet for this study

Summary

During Total hip replacement arthroplasty (THA), the hip joint first must be luxated in order to have access to the joints. A lot of force and torque must be carried out on the joint to perform this manipulation. This is both difficult for the surgeon and may cause additional tissue damage and postoperative pain. After placement of the prosthesis and reduction of the joint, the tension of the hip joint must be evaluated by the surgeon to ascertain the adequacy of the prosthesis. During luxation, minimal muscle tension would be ideal, while after reduction of the joint, normal muscle tension is desired to permit assessment of the mechanics of the hip joint.

The aim of the study is to investigate whether deep neuromuscular block, combined with a reversal before mechanics assessment improves surgical conditions, surgical time, and postoperative patient comfort.

Conditions

  • Surgery
  • Postoperative Pain

Interventions

DRUG

Rocuronium

rocuronium is administered in bolus and continuous infusion

DRUG

Sugammadex

Sugammadex is administered just before reduction of the joint

DRUG

Placebo

Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump. Placebo is administered as alternative to sugammadex

Sponsors & Collaborators

  • Algemeen Ziekenhuis Maria Middelares

    lead OTHER

Principal Investigators

  • Alain F Kalmar, MD, PhD, MSc · Maria Middelares Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2018-04-30
Completion
2018-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369782 on ClinicalTrials.gov