Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331611
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-19
Brief Title:
MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA
Sponsor:
Istituto Giannina Gaslini
Organization:
Istituto Giannina Gaslini
Study Overview
Official Title:
MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA RANDOMISED CLINICAL STUDY
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOTOR
Brief 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 dosekg 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 hoursanesthesia 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 gt 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 11 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 Fishers exact test and Students 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 210 IBM Armonk NY USA
The main objective of the study is to analyse the incidence of sugammadex use and the total dosekg 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 hoursanesthesia 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 gt 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 11 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 Fishers exact test and Students 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 210 IBM Armonk NY USA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None