Effect of NMBA on Surgical Conditions in THR

NCT03369782 | Withdrawn Phase 4

• 1 other identifier: MMS.2017.033
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Muscle Tension; Skeletal Muscle Relaxants; Arthroplasties, Hip Replacement; Rocuronium; sugammadex

Outcome Measures

Primary Outcomes (1)

• Surgical conditions during luxation on a four-grade numeric scale

  Excellent - good but not optimal - poor but acceptable - unacceptable

  during surgery, during luxation of the joint

Secondary Outcomes (4)

• Patient reported pain scores on a VAS score (0-100 ; 0=no pain , 100=worst pain)

  day 0-1-2-7 (day 0 = day of surgery)

• surgery time

  during surgery

• Surgical conditions during reduction of the joint on a four-grade numeric scale

  during surgery, during reduction of the joint

• Surgical conditions for assessment of joint kinetics on a four-grade numeric scale

  during surgery, after reduction of the joint

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo alternative for rocuronium and for sugammadex

Drug: Placebo

Rocuronium

ACTIVE COMPARATOR

Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint

Drug: Rocuronium; Drug: Sugammadex

Interventions

Rocuronium DRUG

rocuronium is administered in bolus and continuous infusion

Also known as: Esmeron

Rocuronium

Sugammadex DRUG

Sugammadex is administered just before reduction of the joint

Also known as: Bridion

Rocuronium

Placebo DRUG

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

Also known as: Saline 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent
• eligible for primary THA
• BMI \<35

You may not qualify if:

• neurological or psychiatric disorders
• intolerance or allergy against investigational drugs or any of the drugs used in the standardized analgetics scheme (acetaminophen, diclofenac, ketamine, clonidine, lidocaine)

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Rocuronium; Sugammadex; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Alain F Kalmar, MD, PhD, MSc

  Maria Middelares Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The syringes are prepared by the research assistant who was not involved in patient management. The anesthetist and surgeon are blinded for patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthetist

Model Details: Group A receives rocuronium, followed by sugammadex. Group B receives placebo

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 12, 2017
• Study Start: December 15, 2017
• Primary Completion: April 30, 2018
• Study Completion: May 31, 2018
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

BE (1)