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

Sakarya University

Status: Unknown

Conditions: The Severity of Agitation in Adenotonsillectomy in Pediatric Patients

Study type: Observational

Funder types: Other

Identifiers

NCT03571867

sugammadex

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: No 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.

Trial design

70 participants in 2 patient groups

group Sugammadex

Description:

After surgery, while the TOF count was 2/4, the residual muscle relaxation was antagonized with 2 mg/kg iv sugammadex + 0.01 ml/kg saline in Group S

group Neostigmine

Description:

After surgery, while the TOF count was 2/4, the residual muscle relaxation was antagonized with 0.02 mg/kg neostigmin+0.01 mg/kg atropine in Group N.