RCT Deep vs Moderat NMB on Surgical Conditions During THP

NCT04170101 | Unknown

• 1 other identifier: 2019RCTdeepNMBTHP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical deep NMB might relax the anterior muscles of the upper leg better than a moderate/superficial block giving a better exposure for the surgeon with less muscle trauma by traction to expose the hip. a continuous deep NMB (group A) versus a non deep NMB (group B) having a moderate to superficial block imitating common practice today as control group. Primary objectives are surgical exposure and Secondary objectives are Muscle damage creatine kinase changes, C-reactive protein (CRP), first time leaving bed postoperative, post operative pain as measured by opioid use postoperative at 24h, with a control of max VAS score during first 24 hour, length of hospital stay (LOS), number of adverse events using the Dindo-Clavien surgical complication score, QoR15 measured at 24h on the ward.

Conditions

Muscle Injury

Outcome Measures

Primary Outcomes (1)

• surgical exposure

  After the surgical procedure the surgeon will be asked to score the surgical conditions on an adapted five point Leiden scale (validated scale): max = 5 and best; min = 1 and worst grade 5: optimal surgical conditions, perfect access to the hip joint and excellent visibility. grade 4: good conditions: adequate surgical conditions to perform the surgery, but not optimal grade 3: just acceptable conditions, surgical procedure is jeopardized, but adequate surgical result is still obtained, eventually after additional intervention grade 2: poor conditions, exposure and handling hindered resulting in suboptimal surgical outcome requiring adaptation of procedure or interventions to improve condition. grade 1: extremely poor conditions, the surgeon is unable to work because of the inability to get access to the hip joint because of inadequate muscle relaxation and request to improve conditions first before continuing.

  from incision till end of surgery stop at day zero

Secondary Outcomes (7)

• muscle injury

  on photo after procedure stop at day zero

• creatinine kinase (CK)

  24 hours after surgery stop at day 1

• C-reactive protein (CRP)

  24 hours after surgery stop at day 1

• leaving bed

  within 24 hours postoperative stop at day 1

• Length of stay

  measured in days up to one week post surgery stop at day 7

Study Arms (2)

a continuous deep NMB (group A)

EXPERIMENTAL

after 0,6 mg/kg LBW Rocuronium for intubation Rocuronium is given in a continuous infusion starting at 1 mg/kg/h and adapted to keep PTC below 5 and note.

Procedure: deep NMB

non deep NMB (group B)

PLACEBO COMPARATOR

after 0,6 mg/kg LBW Rocuronium for intubation no extra NMB is given and depth is measured by TOF/PTC to note depth.

Procedure: moderate NMB

Interventions

deep NMB PROCEDURE

0,6 mg/kg LBW Rocuronium is used to facilitate intubation, and followed by an infusion of 1 mg/kg LBW/h , further adapted to keep PTC \< 3

a continuous deep NMB (group A)

moderate NMB PROCEDURE

0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus.

non deep NMB (group B)

Eligibility Criteria

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

You may qualify if:

• Hip arthroplasty by anterior approach using Minimally Invasive Surgery

You may not qualify if:

• Revision arthroplasty.
• Allergy or contra indications to use any of the drugs included in anesthesia.
• Addiction to or chronic opioid use before surgery.
• Major cardiovascular, pulmonary, liver or renal insufficiency before surgery requiring possible post-operative intensive care admission.
• Contra indication for a general anesthesia with intubation and mechanical ventilation.

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

Azsintjan

Bruges, 8000, Belgium

Location

Study Officials

• jan mulier

  AZSint Jan AV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Paul Mulier, MD PhD

CONTACT

+3250452490; jan.mulier@azsintjan.be

Jan VanLommel, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof dr

Model Details: a continuous deep NMB (group A) versus a non deep NMB (group B) having a moderate to superficial block imitating common practice today as control group.

Study Record Dates

• First Submitted: November 16, 2019
• First Posted: November 20, 2019
• Study Start: April 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: January 20, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)