Comparison of The Severity of Agitation of Sugammadex and Atropine-Nesostigmine in Adenotonsillectomy

Comparison of The Severity of Agitation of Sugammadex and Atropine-Nesostigmine in Adenotonsillectomy in Pediatric Patients? : a Double Blind Randomised Clinical Trial

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03571867

Enrollment

Registered

2018-06-28

Start date

2018-07-01

Completion date

2018-11-01

Last updated

2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Severity of Agitation in Adenotonsillectomy in Pediatric Patients

Keywords

Adenotonsillectomy, Severity of Agitation, Sugammadex

Brief summary

the use of sugammadex during the reversal of neuromuscular blocking after adenotonsillectomy surgery in pediatric patients would be advantageous in terms of patient comfort and reducing side effects. Thus, we aimed to evaluate the time to extubation, agitation and pain scores in pediatric patients who underwent adenotonsillectomy and awakened with neostigmine and sugammadex in our study.

Detailed description

A total of 70 patients in the American Society of Anesthesiologists (ASA) I-II risk group, aged 5-13 years, who will be undergoing adenotonsillectomy with recurrent / chronic tonsillitis or obstructive sleep apnea in the otorhinolaryngology clinic of our hospital were included. Investigator did not assign specific interventions to the study participants. Patients were selected to sugammadex + saline group (Group S) and neostigmin+atropine group (Group N) and 35 patients were seleceted for each group randomly. Patients receive interventions as part of routine medical care, and a researcher studies the effect of the intervention. Tracheal extubation time (from discontinuing anesthetics until extubation), Duration of anesthesia (from the injection of anesthetic until discontinuation) duration of the operation (from the injection of anesthetic until until the patient's discharge from the operating room) were recorded for each patient. We assessed the agitation level with the Pediatric Anesthesia Emergence Delirium (PAED), which provides a score from 0 to 20, at first 15 minutes (T0), 1st (T1), 4th (T4), 8th (T8) and 12th (T12) hours post-extubation

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 13 Years

Healthy volunteers

Inclusion criteria

* patient who will be undergoing adenotonsillectomy with recurrent / chronic tonsillitis or obstructive sleep apnea in the otorhinolaryngology clinic * American Society of Anesthesiologists (ASA) I-II risk group, * aged 5-13 years,

Exclusion criteria

* patients with history of allergy to any medication used during general anesthesia, * known or suspected neuromuscular disorders that impair neuromuscular blockade, * liver and kidney disease, * asthma, * bleeding diathesis. * Written and verbal consents were obtained from the legal guardians of the patients who are blınded of the groups to participate in the study.

Design outcomes

Primary

Measure	Time frame	Description
agitation level	1 month	Pediatric Anesthesia Emergence Delirium (PAED), which provides a score from 0 to 20

Secondary

Measure	Time frame	Description
pain levels	1 month	The pain levels were assessed with visual analogue scale (VAS) scores which assessment scale ranging from 0 to 10 according to the face expression was used

Countries

Turkey (Türkiye)

Contacts

Primary ContactHavva Sayhan, Assis Prof

hsayhan@gmail.com+905056621021

Backup Contactmüge yılmaz, MD