Comparison of The Severity of Agitation of Sugammadex and Atropine-Nesostigmine in Adenotonsillectomy in Pediatric Patients? : a Double Blind Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- agitation level
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •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.
Outcomes
Primary Outcomes
agitation level
Time Frame: 1 month
Pediatric Anesthesia Emergence Delirium (PAED), which provides a score from 0 to 20
Secondary Outcomes
- pain levels(1 month)
Investigators
Havva Sayhan
assistant professor
Sakarya University