MedTrace Logo

Sugammadex and Neostigmine in Pediatric Patients

NCT05618236 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2024-05-29

No results posted yet for this study

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

Interventions

DRUG

Group N; neostigmine+atropine

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.

DRUG

GROUP S; decurarized with sugammadex.

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.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • MELIHA ORHON ERGUN · Marmara University

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2023-10-25
Completion
2024-04-15
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05618236 on ClinicalTrials.gov