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Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?

Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03219294
Enrollment
116
Registered
2017-07-17
Start date
2017-05-01
Completion date
2018-05-01
Last updated
2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Hip

Keywords

neuromuscular blockade, sugammadex

Brief summary

During many surgeries, increased muscle tension makes it harder for the surgeon to expose the site of surgery and work within the incision. Neuromuscular blockade (NMB) drugs such as Vecuronium bind to neurotransmitter (acetyl choline) receptors at the neuromuscular junction, blocking their action and producing muscle relaxation. This muscle relaxation allows easier retraction of muscle tissues and manipulation of structures in the wound. Improved surgical conditions are likely to result in improved patient outcomes. While increased depths of NMB have been shown to optimize surgical conditions during intra-abdominal and retroperitoneal procedures, the impact of NMB depth has not been reported for orthopedic surgeries.1 To address this, we propose to study the effect of NMB depth on surgical conditions during total hip replacement (THR).

Detailed description

Specific Aims 1. 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: 1. 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. 2. 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. 2. 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.

Interventions

DRUGVecuronium 0.1 mg/kg

Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.

DRUGVecuronium 0.2mg/kg

Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.

Sponsors

MaineHealth
CollaboratorOTHER
Spectrum Medical Group Anesthesiology
CollaboratorOTHER
Craig Curry
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The anesthesiologist will NOT be blinded, but the orthopedic surgeon performing the hip replacement surgery will be.

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) Physical status 1-3 * age 50-75 * English speaking * able to provide informed consent * BMI equal to less than 30 * non-emergent THR by anterolateral minimally invasive non-cemented total hip arthroplasty

Exclusion criteria

* Revision surgery * Bilateral THR * ASA 4+ * age less than 50 or greater than 75 * BMI greater than 30 * unable to provide informed consent * women taking oral contraceptives (Sugammadex used for reversal interferes with their efficacy * contraindications to general inhalation anesthesia (such as malignant hyperthermia) * contraindications to NMB (known allergy to NMB) * chronic kidney disease

Design outcomes

Primary

MeasureTime frameDescription
Surgical ConditionsThrough 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).

Secondary

MeasureTime frameDescription
Duration of SurgeryThrough 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Moderate 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 TOF contractions. Redosing in this manner is a current clinical practice. Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.
58
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 MMC but is in common use since the advent of Sugammadex. Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
58
Total116

Baseline characteristics

CharacteristicDeep NMBTotalModerate NMB
Age, Continuous62.9 years
STANDARD_DEVIATION 7.4
63 years
STANDARD_DEVIATION 7.04
63.1 years
STANDARD_DEVIATION 6.7
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
58 participants116 participants58 participants
Sex: Female, Male
Female
30 Participants59 Participants29 Participants
Sex: Female, Male
Male
28 Participants57 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 580 / 58
other
Total, other adverse events
0 / 580 / 58
serious
Total, serious adverse events
0 / 580 / 58

Outcome results

Primary

Surgical Conditions

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).

Time frame: Through study completion, an average of 24 hours.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Moderate NMBSurgical ConditionsExtremely Poor Conditions1 Participants
Moderate NMBSurgical ConditionsAcceptable Conditions30 Participants
Moderate NMBSurgical ConditionsGood Conditions15 Participants
Moderate NMBSurgical ConditionsOptimal Conditions1 Participants
Moderate NMBSurgical ConditionsPoor Conditions11 Participants
Deep NMBSurgical ConditionsOptimal Conditions2 Participants
Deep NMBSurgical ConditionsExtremely Poor Conditions2 Participants
Deep NMBSurgical ConditionsPoor Conditions10 Participants
Deep NMBSurgical ConditionsGood Conditions15 Participants
Deep NMBSurgical ConditionsAcceptable Conditions29 Participants
Secondary

Duration of Surgery

Time from incision to joint reduction

Time frame: Through study completion, an average of 24 hours for each patient and up to one year for the whole study.

ArmMeasureValue (MEAN)Dispersion
Moderate NMBDuration of Surgery32.6 minutesStandard Deviation 1.2
Deep NMBDuration of Surgery33.8 minutesStandard Deviation 1.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026