Clinical trial NCT04471376: The Effect of Sugammadex During Transcranial Electrical Motor Evoked Potential Monitoring in Spinal Surgery
Official title: Intraoperative Reversal of Muscle Relaxants During Transcranial Electrical Motor Evoked Potential Monitoring in Patients Undergoing Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sugammadex
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. However, full blockade offers increased anesthetic management options and facilitates surgery. Here, investigators want to assess the effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.


Eligibility criteria: Inclusion Criteria:

* 18-65 years
* ASA status I-II
* Patients undergo thoracic or lumbar spinal surgery
* tcMEP monitoring during the surgery
* Informed consent signed by patients

Exclusion Criteria:

* BMI ≥35 Kg/m-2
* history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s)
* history or family history of malignant hyperthermia
* allergies to sugammadex, NMBs or other medication(s) used during general anesthesia
* anemia, hemoglobin \<110g/L,
* TcMEPs stimulate or record site infection
* preoperative neurological dysfunction in both upper extremities
* cardiac pacemaker
* pregnancy and breast-feeding

Primary outcomes:
measure: The amplitude of MEP
timeFrame: 5 minutes after dura opening
Secondary outcomes:
measure: The amplitude of MEP
timeFrame: 10, 20, 30 and 60 minutes after dura opening
measure: The latencies of MEPs
timeFrame: 5, 10, 20, 30 and 60 minutes after dura opening.
measure: Respiratory parameters
timeFrame: during the surgery
measure: Adverse effects of sugammadex
timeFrame: during and 24 hours after the surgery
measure: Incidence of body movement
timeFrame: during the surgery
measure: Recurrence of neuromuscular blockade
timeFrame: At the end of surgery
measure: Motor function assessment
timeFrame: 5 days after surgery
measure: Total bleeding volume
timeFrame: during the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Department of Anesthesiology, Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph.D
role: STUDY_CHAIR
References: