Clinical trial NCT02724111: Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery
Official title: Comparison of Operating Conditions, Postoperative Recovery and Overall Satisfaction Between Deep and Restricted Neuromuscular Blockade for Spinal Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Surgery
Anesthesia
Spinal Diseases
Keywords: Neuromuscular blockade
Surgical rating scale
Rocuronium
Sugammadex
Spinal surgery
General anesthesia
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-03-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aim to investigate operating conditions, postoperative recovery and overall satisfaction of surgeons between deep neuromuscular blockade (NMB) group and restricted NMB group during spinal surgery under general anesthesia. The investigators hypothesize that this study can present good surgical conditions, postoperative recovery outcomes and overall satisfaction of surgeons in deep NMB group, thereby proving the advantages of deep NMB as well as flaws of restricted NMB in spine surgeries.

Detailed description: * Group treatment (Arms): group treated with restricted neuromuscular blockade (NMB) (Group RB); group treated with deep NMB (Group DB) → randomized allocation (subjects: motor-evoked potential \[MEP\] not monitored surgeries)
* Inclusion criteria: American Society of Anesthesiologists (ASA) physical status I-II adults, aged 18-75 years, scheduled for elective spinal surgery (cervical or lumbar surgeries which have lesions no more than 3 spinal levels and not monitored by MEP) of duration \>1 hour and prone position under total intravenous anesthesia (TIVA).
* Exclusion criteria: Pregnancy, the receipt of medication known to interfere with neuromuscular blockade, diseases affecting neuromuscular transmission, and the history of hypersensitivity on rocuronium or sugammadex. The patients who will have hemodynamic instability, mean blood pressure increase or fall of \> 30% from baseline (lasting for more than 5min), and blood loss \> 1 L during surgery, and MEP monitored surgeries.
* Outcome Measures

  * Primary outcome: Mean value of peak inspiratory pressure recorded every 15 minutes.
  * Secondary outcomes:

    1. The number of body movements (including cough or any diaphragm movement).
    2. The degree of bleeding of each patient scaled by surgeons (Intraoperative scale for assessment of operating condition of surgical field: 0 - No bleeding, 1 - Slight bleeding - no suctioning of blood required, 2 - Slight bleeding - occasional suctioning required but not threatened the operative field, 3 - Slight-bleeding - frequent suctioning of blood was required that threatens the operative field a few seconds after suctioning, 4 - Moderate bleeding - frequent suctioning of blood was required which threatens the operative field directly after suctioning, 5 - Sever bleeding - continuous suctioning of blood was required which severely threatened the operative field make the surgery not possible).
    3. The muscle tone of each patient scaled by surgeons (1: muscle tone is good, suitable for surgery; 2: muscle tone is moderate, but do not affect the operation; 3: muscle tone is hard, making the operation difficult.).

       * Three time-points of assessment of the muscle tone: ① At the placement of back muscle retractor for opening the operating site after the skin and subcutaneous incision, ② At the screw insertion through the pedicle of spine during surgery, ③ At the other period (overall muscle tone).
    4. Mean value of pressure of back muscle retractor placed in the operating site (recorded every 15 minutes): measured by the pressure probe placed between the retractor and the back muscle.
    5. Overall satisfaction of surgeons for the surgical condition will be assessed by the surgeons who perform surgery using numerical rating scale (NRS; 1-10) after surgery.
    6. Recovery profiles including eye opening time, extubation time and sedation score (the Observer's Assessment of Alertness/ Sedation (OAA/S) score; awake, 5 to unresponsive, 1) every 10 min for 1 hour at postanesthesia care unit (PACU).
    7. Postoperative adverse events

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II adult patients scheduled for elective spinal (cervical or lumbar) surgery under general anesthesia

Exclusion Criteria:

* Pregnancy
* Present medication known to interfere with neuromuscular blockade
* Diseases affecting neuromuscular transmission
* History of hypersensitivity on rocuronium or sugammadex
* Emergent spinal surgery
* Spinal surgeries which have lesions more than 3 spinal levels
* Spinal surgeries which have duration less than 1 hour
* Spinal surgeries which are not performed under prone position
* Spinal surgeries which are not performed under total intravenous anesthesia (TIVA).
* Patients who will have hemodynamic instability (mean blood pressure increase or fall of \> 30% from baseline lasting for more than 5 min) during surgery
* Patients who will have blood loss \> 1 L during surgery
* MEP monitored spinal surgeries

Primary outcomes:
measure: Mean Value of Peak Inspiratory Pressure
timeFrame: Every 15 minutes during anesthesia, up to 3 hours
Secondary outcomes:
measure: Mean Value of Pressure of Back Muscle Retractor
timeFrame: Every 15 minutes at the period of the retractor placement during surgery, up to 2 hours
measure: Overall Satisfaction of Surgeons for the Surgical Condition
timeFrame: After surgery
measure: The Muscle Tone
timeFrame: at the screw insertion through the pedicle of spine during surgery
measure: The Number of Body Movements
timeFrame: At the occurrence of the event during surgery, up to 3 hours
measure: The Degree of Bleeding
timeFrame: Continuously observed during the whole period of surgery, up to 3 hours
measure: Recovery Time (Time to Reach Sedation Score 5 at Postanesthesia Care Unit (PACU).
timeFrame: every 10 min for 1 hour at PACU.
measure: Adverse Events : The Postoperative Nausea and Vomiting Occurrence in Subject
timeFrame: during the postoperative 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Byung Gun Lim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: