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NCT Number: NCT02724111

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Guro Hospital

Seoul, 08308, South Korea

About this study

  • 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:
  • The number of body movements (including cough or any diaphragm movement).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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).
  • Postoperative adverse events

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sufficient dose of rocuronium

Drug

Other names: sugammadex at the end of surgery

sugammadex 10 min after position change

Drug

Other names: restricted dose of rocuronium

Primary outcomes

  1. Mean Value of Peak Inspiratory Pressure

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

    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

Secondary outcomes

  1. Mean Value of Pressure of Back Muscle Retractor

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

    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.

  2. Overall Satisfaction of Surgeons for the Surgical Condition

    Time frame: After surgery

    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).

  3. The Muscle Tone

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

    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.).

  4. The Number of Body Movements

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

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

  5. The Degree of Bleeding

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

    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).

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

    Time frame: every 10 min for 1 hour at 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

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

    Time frame: during the postoperative 24 hours

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

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Comparison of Operating Conditions, Postoperative Recovery and Overall Satisfaction Between Deep and Restricted Neuromuscular Blockade for Spinal Surgery Under General Anesthesia

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2016
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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