Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery

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• Spinal Diseases 267

Keywords

• Neuromuscular blockade
• Surgical rating scale
• Rocuronium
• Sugammadex
• Spinal surgery
• General anesthesia

Spinal Diseases

267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.

This study's enrollment of 90 is above the median of 52 across 166 interventional studies indexed under Spinal Diseases.

Lead sponsor

Korea University Guro Hospital is the lead sponsor of 83 studies on the registry; 15 are open to participants now.

Study arms

• Experimental
  deep neuromuscular blockade

  This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (train-of-four \[TOF\] count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

  Drug: sufficient dose of rocuronium

• Active comparator
  restricted neuromuscular blockade

  This arm will not be given sufficient dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

  Drug: sugammadex 10 min after position change

Interventions

• Drugsufficient dose of rocuronium

  Also known as: sugammadex at the end of surgery

• Drugsugammadex 10 min after position change

  Also known as: restricted dose of rocuronium

Primary outcomes

1. Mean Value of Peak Inspiratory Pressure

   This outcome is the mean value of the peak inspiratory pressure measured at each 15 minute during the anesthesia, which can reflect the degree of the tone of respiratory muscles. As muscle tone increases, airway pressure usually increases due to increased tone of abdominal muscle and respiratory muscles including diaphragm. The longer the surgery goes, the higher the airway pressure gets. Also, as neurospinal surgeries are operated in the prone position, the potential for increased airway pressure is high. As airway pressure gets higher, intrathoracic pressure and intraabdominal pressure also become higher. These consequences may bring about similar results with detrimental effects derived from marked increase in intraabdominal pressure in laparoscopic abdominal surgeries

   Time frame: Every 15 minutes during anesthesia, up to 3 hours

Secondary outcomes

1. Mean Value of Pressure of Back Muscle Retractor

   Mean value of pressure of back muscle retractor placed in the operating site (recorded every 15 minutes during the placement of the retractor): measured by the pressure probe placed between the retractor and the back muscle.

   Time frame: Every 15 minutes at the period of the retractor placement during surgery, up to 2 hours

2. Overall Satisfaction of Surgeons for the Surgical Condition

   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 (1, worst; 10, best).

   Time frame: After surgery

3. The Muscle Tone

   The muscle tone of each patient at the screw insertion through the pedicle of spine during surgery 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.).

   Time frame: at the screw insertion through the pedicle of spine during surgery

4. The Number of Body Movements

   The number of body movements (including cough or any diaphragm movement) observed during the surgery.

   Time frame: At the occurrence of the event during surgery, up to 3 hours

5. The Degree of Bleeding

   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 - Severe bleeding - continuous suctioning of blood was required which severely threatened the operative field make the surgery not possible).

   Time frame: Continuously observed during the whole period of surgery, up to 3 hours

6. Recovery Time (Time to Reach Sedation Score 5 at Postanesthesia Care Unit (PACU).

   the time to reach sedation score 5 (the Observer's Assessment of Alertness/ Sedation (OAA/S) score; awake, 5 to unresponsive, 1) at PACU

   Time frame: every 10 min for 1 hour at PACU.

7. Adverse Events : The Postoperative Nausea and Vomiting Occurrence in Subject

   The occurrence of any adverse events was recorded in the post-anesthesia care unit (PACU) and a ward during the postoperative 24 hours.

   Time frame: during the postoperative 24 hours

Baseline characteristics

Study documents

• Study protocol · Feb 4, 2016
• Statistical analysis plan · Feb 4, 2016
• Informed consent form · Jun 9, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No