Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery
Condition: Neuromuscular Blockade; Surgery; Anesthesia; Spinal Diseases
MeSH terms: Spinal Diseases
Study type: Interventional
Phase: Phase 4

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
    

Intervention name(s): sufficient dose of rocuronium; sugammadex 10 min after position change
Intervention type(s): Drug; Drug
Other intervention name(s): sugammadex at the end of surgery; restricted dose of rocuronium
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Neuromuscular blockade; Surgical rating scale; Rocuronium; Sugammadex; Spinal surgery; General anesthesia