Sugammadex and Neostigmine in Pediatric Patients

NCT05618236 | Completed FDA Drug

• 1 other identifier: 09.2022.98
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it was aimed to compare the use of sugammadex instead of neostigmine + atropine in the reversal of NMB in children undergoing lower abdominal surgery or urogenital surgery, and to compare the rates of postoperative agitation, nausea and vomiting using the FLACC scale, PAED scale and ICC parameters.After the approval of the local ethics committee and written consent from the family, patients who underwent ASA 1, 5-12 years old lower abdomen surgery or urogenital surgery in Pendik Training and Research Hospital will be included in the study. The patients included in the study will be those who were maintained with routine 2-3% sevoflurane inhalation anesthetic and 0.2mcg/kg/min remifentanil intravenous anesthetic, and decurarized with 0.5-1 mg/kg rocuronium. No drugs other than those administered by the responsible Anesthesiologist during the operation will be administered. The patients included in the study will be divided into 2 groups according to the agent used in decurarization. There is no condition for the number of patients in the group to be equal. Group N; neostigmine+atropine, GROUP S; This will be the group of patients decurarized with sugammadex. 0-45 days after patients are extubated. And at the 2nd hour, FLACC Scale (Pain Diagnostic Scale), PAED (Pediatric Anesthesia Recovery Delirium) Scale assessment methods will be compared in terms of pain and agitation. Nausea and vomiting will be noted as yes/no.

Conditions

Postoperative Vomiting; Postoperative Nausea; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• postoperative delirium

  after patients are extubated. Evaluation Pediatric Anesthesia Recovery Delirium Scale at 2nd Hour

  postoperatif first 2 hours.

Secondary Outcomes (1)

• postoperative pain

  postoperatif first 2 hours.

Study Arms (2)

neostigmin+atropin

This will be the group of patients decurarized with neostigmine+atropine,

Drug: Group N; neostigmine+atropine

sugammadeks

This will be the group of patients decurarized with sugammadex.

Drug: GROUP S; decurarized with sugammadex.

Interventions

Group N; neostigmine+atropine DRUG

The patients included in the study will be divided into 2 groups according to the agent used in decurarization. There is no condition for the number of patients in the group to be equal. Group N; neostigmine+atropine, GROUP S; This will be the group of patients decurarized with sugammadex. 0-45 days after patients are extubated. And at the 2nd hour, FLACC Scale (Pain Diagnostic Scale), PAED (Pediatric Anesthesia Recovery Delirium) Scale assessment methods will be compared in terms of pain and agitation. Nausea and vomiting will be noted as yes/no.

Also known as: neostigmine+atropine

neostigmin+atropin

GROUP S; decurarized with sugammadex. DRUG

The patients included in the study will be divided into 2 groups according to the agent used in decurarization. There is no condition for the number of patients in the group to be equal. Group N; neostigmine+atropine, GROUP S; This will be the group of patients decurarized with sugammadex. 0-45 days after patients are extubated. And at the 2nd hour, FLACC Scale (Pain Diagnostic Scale), PAED (Pediatric Anesthesia Recovery Delirium) Scale assessment methods will be compared in terms of pain and agitation. Nausea and vomiting will be noted as yes/no.

Also known as: sugammadex

sugammadeks

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

ASA 1, patients aged 5-12 years who will undergo lower abdominal surgery or urogenital surgery

You may qualify if:

• After the approval of the local ethics committee and written consent from the family ASA 1 5-12 years old

You may not qualify if:

• history of allergy or anaphylaxis to one of the drugs used children with autism children with auditory problems family without consent

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Emergence Delirium

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• MELIHA ORHON ERGUN

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: November 8, 2022
• Primary Completion: October 25, 2023
• Study Completion: April 15, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

TU (1)