An interventional study of deep NMB and moderate NMB in Muscle Injury, sponsored by AZ Sint-Jan AV. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by AZ Sint-Jan AV · Not applicable, Interventional, and Supportive care
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.
In this study, CRP levels are choosen as it is measured standard in every total hip arthroplasty (THA) procedure. CK is a good biomarker for muscle trauma and therefore chosen as second marker.
The study is blinded for the treating surgeon, who will be making the assessment for the surgical conditions. The attending anesthesiologist is not blinded as he has to measure NMB in both groups and give a rocuronium infusion to stay deep in the study group. The anesthesiologist and the nurses following the patient on the post anesthetic care unit (PACU) and the ward are different from the attending anesthesiologist and are blinded. They will not be informed by the attending anesthesiologist on randomization allocation.
Randomization:
Group A deep NMB group:
Group B moderate to superficial NMB group:
0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus.train of four ( TOF) and PTC are measured at the beginning of surgery without informing the surgeon of the depth. (surgeon is blinded)
2 weeks before surgery at consultation of orthopedics and anesthesia:
Day before surgery:
Anesthesia \& surgery performed
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AZ Sint-Jan AV is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Revision arthroplasty.
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
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
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
0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus.
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.
Time frame: from incision till end of surgery stop at day zero
muscle injury
This is scored on an adapted five point scale post surgery on a light photo taken at end of surgery before closing, by an orthopedic surgeon not around during surgery. max = 5 and best; min = 1 and worst grade 1: muscle severely damaged with open cuts; grade 2: muscle damaged with free tears; grade 3: muscle superficial damaged and swollen; grade 4: muscle intact, but swollen or perfusion not optimal grade 5: muscle intact without swelling and normal perfused.
Time frame: on photo after procedure stop at day zero
creatinine kinase (CK)
creatinine kinase (CK) changes as a measure for muscle trauma, at 24 hours postoperative versus baseline
Time frame: 24 hours after surgery stop at day 1
C-reactive protein (CRP)
C-reactive protein (CRP) changes as a measure for inflammation, at 24 hours postoperative versus baseline.
Time frame: 24 hours after surgery stop at day 1
leaving bed
First time leaving bed postoperative
Time frame: within 24 hours postoperative stop at day 1
Length of stay
Length of hospital stay (LOS)
Time frame: measured in days up to one week post surgery stop at day 7
postoperative complications
Number of adverse events using the Dindo-Clavien surgical complication score
Time frame: up to two weeks postoperative stop at day 14
quality of recovery
15 Quality of recovery questions (QoR15) measured at 24h on the ward and at 2 weeks post operative max: 150: best; min: 0: worst each question is answered on a scale from 0 to 10.
Time frame: 2 weeks postoperative stop at day 14
Plan to share: No
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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AZ Sint-Jan AV