Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
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|ClinicalTrials.gov Identifier: NCT03219294|
Recruitment Status : Completed
First Posted : July 17, 2017
Results First Posted : September 10, 2019
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Arthropathy of Hip||Drug: Vecuronium 0.1 mg/kg Drug: Vecuronium 0.2mg/kg||Phase 4|
Assess difference in surgical conditions between moderate and deep NMB groups. Enrolled patients will be randomized to receive moderate (n=58) or deep (n=58) NMB. Difference in surgical conditions will be evaluated by:
- The number of requests from the surgeon for additional relaxation (NMB) during the procedure. At any time during the operation if the surgeon feels the muscle tension is interfering with ease of operation he will ask for additional muscle relaxation. If the patient is moderately relaxed they will be converted to deep relaxation with additional muscle relaxants. If they are already deeply relaxed no additional relaxants will be administered (as is our current practice). All requests will be recorded.
- Rating by the surgeon after each surgery using an internally developed satisfaction scale. The scale was developed by modifying a scale used in a previous study of muscle relaxation in intra-abdominal surgery1 to specify two key elements identified by our surgeon: ease of muscle retraction and femur manipulation.
- Assess the impact of deep vs moderate NMB on time of surgery, measured from the time of incision to joint reduction.
SIGNIFICANCE If we identify improved surgical conditions with deeper relaxation we will incorporate deep NMB into our routine anesthesia practice for THR.
Vecuronium will be used as NMB drug in all study patients; this agent is currently used in over 90% of THR cases at Maine Medical Center (MMC). As is currently routine Vecuronium will be given after initiation of general anesthesia with propofol to facilitate intubation and further doses of Vecuronium will be given throughout the case as noted below to maintain NMB at the desired depth until the femoral implant is reduced. After the intubating dose of Vecuronium, NMB depth will be monitored every 5 minutes and dosing will be adjusted as needed to maintain a constant depth of NMB according to our current routine practice.
Group 1: Moderate NMB: Intubating dose of Vecuronium of 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.
Group 2: Deep NMB: Intubating dose of Vecuronium of 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 MMC but is in common use since the advent of Sugammadex.
The surgeon may request additional relaxation at anytime for inadequate surgical conditions thought to be related to muscle tension. All requests will be recorded. Patients in the moderate NMB group will receive additional doses of vecuronium to achieve deep NMB (PTC of 1- 2). In the deep NMB group with PTC of 1-2, a saline dose without NMB will be given.
NMB reversal Sugammadex will be given for reversal of NMB after the prosthesis has been reduced, using routine dosing of 2 mg/kg for the moderate group and 4 mg/kg for the deep group, per package insert by Merck.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||The anesthesiologist will NOT be blinded, but the orthopedic surgeon performing the hip replacement surgery will be.|
|Official Title:||Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||May 1, 2018|
Active Comparator: Moderate Neuromuscular Blockade (NMB)
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
Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.
Other Name: vecuronium bromide
Active Comparator: Deep NMB
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
Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
Other Name: vecuronium bromide
- Surgical Conditions [ Time Frame: Through study completion, an average of 24 hours. ]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).
- Duration of Surgery [ Time Frame: Through study completion, an average of 24 hours for each patient and up to one year for the whole study. ]Time from incision to joint reduction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219294
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States, 04102|
|Principal Investigator:||Craig Curry, MD||Maine Medical Center/Spectrum Medical Group|