Clinical Trials Logo

Clinical Trial Summary

To date there is still little scientific evidence regarding neuromuscular block monitoring in pediatric anesthesia and indications for safe reversal. Although the use of rocuronium and sugammadex is becoming wide, qualitative monitoring or clinical practice are applied instead of quantitative monitoring (acceleromyography-electromyography EMG). The use of neuromuscular monitoring leads to better control of intraoperative paralysis, proper timing of extubation, and reduced risk of residual postoperative paralysis-paralysis (PORC) and related complications. The main objective of the study is to analyse the incidence of sugammadex use and the total dose/kg, with and without the aid of quantitative neuromuscular monitoring. Secondary objectives are: - the time required to extubate different patients, - the incidence of respiratory complications at extubation, - the need to administer additional doses of sugammadex. A prospective RCT. Patients will be divided into two study groups; in the first group, quantitative neuromuscular monitoring based on electromyography (EMG) will be used, while in the second group, the same monitoring will be applied but covered (blinded to the anesthetist) and the pharmacological strategy is based exclusively on the clinical practice All children aged between 2 months and 6 years, scheduled to undergo elective non-cardiac surgical procedures, lasting approximately from one to two hours(anesthesia time), with general anesthesia and tracheal intubation receiving a non-depolarizing blockade agent. - Children between 2 months and 6 years - Children who will undergo elective non cardiac surgery (maximum two hours of anesthesia time with tracheal intubation receiving a non depolarizing blockade agent), - Acquisition of informed consent by a legally recognized representative capable of understanding the document and providing consent on behalf of the participant. - Children under 2 months of age or over 12 years of age, - Children with an ASA classification > 3, - Presence of neuromuscular disease, channelopathy, or any clinical condition that contraindicates the administration of neuromuscular muscle relaxants, - Confirmed or suspected allergy to sugammadex or rocuroniumt, - Presence of amputation or limb malformations that make placement of neuromuscular monitoring impossible, - Any specific contraindication to any aspect of the protocol. 12 months The randomization process will performed using numbers randomized by a computer-generated random number sequence. The randomization list will be prepared by independent statistician . The subjects will be assigned to the treatment arm in a sequence as per the randomization code provided in a closed envelope in a 1:1 ratio. The investigator will administered the treatment as per the randomization codes. One hundred children undergo in the clinically guided group and 100 children in the neuromuscular monitoring groups with the aim to include 200 children in total. Demographics and baseline characteristics with mean, median, standard deviation, and range (minimum, maximum) will generated for each arm. Subject disposition, including the number of subjects withdrawn or discontinued from the study, for each arm will summarized. The study will follow the CONSORT guidelines for statistical analysis and reporting. Chi squared test or Fisher's exact test and Student's t-test or Mann Whitney test will applied to categorical and continuous data, respectively, with a significance level of 5% by two-sided test. Statistical analysis was performed using SPSS software (ver. 21.0) (IBM, Armonk, NY, USA).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06331611
Study type Interventional
Source Istituto Giannina Gaslini
Contact Nicola Disma
Phone 3901056361
Email nicoladisma@gaslini.org
Status Not yet recruiting
Phase N/A
Start date May 1, 2024
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05558969 - The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex N/A
Completed NCT03168308 - Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients Phase 4
Not yet recruiting NCT03978780 - Erector Spinae Block vs. Placebo Block Study N/A
Completed NCT02912039 - Electromyographic Assessment of the TetraGraph in Normal Volunteers
Completed NCT02892045 - Mindray Neuromuscular Transmission Transducer
Completed NCT03427385 - Minimum Local Anesthetic Dose for Adductor Canal Block N/A
Completed NCT01450813 - The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy N/A
Completed NCT00535496 - Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698) Phase 3
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Not yet recruiting NCT05993390 - Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients N/A
Recruiting NCT04609410 - Bleeding in Laparoscopic Liver Surgery N/A
Terminated NCT03649672 - The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor N/A
Completed NCT05687253 - Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery Phase 2
Completed NCT05474638 - Comparison of Mechanomyographic 100 Versus 200 Hz 5 Second Tetanic Fade Ratios During Neuromuscular Block Recovery N/A
Completed NCT05120999 - Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring
Completed NCT03608436 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery Phase 4
Completed NCT03572413 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis. Phase 4
Recruiting NCT02930629 - Residual Block in Postoperative Anaesthetic Care Unit N/A
Completed NCT02932254 - Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex Phase 4
Completed NCT01828385 - Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex Phase 4