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Sugammadex Effects on Children's Awakening from Adenotonsillectomy Surgery

The Effects Of Sugammadex On Emergence Agitation In Children Undergoing Adenotonsillectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000963224
Enrollment
90
Registered
2018-06-07
Start date
2018-06-07
Completion date
2018-07-30
Last updated
2019-01-14

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

Conditions

None listed

Brief summary

Safe and adequate return of airway reflexes and cognitive functions during recovery period after general anaesthesia is important especially in short-term paediatric surgeries. The most stressful experience for children during perioperative period is anaesthesia induction but awakening in foreign environment without parents is similarly stressful. We purposed to search if sugammadex causes or increases emergence agitation and laryngospasm due to fast termination of the neuromuscular blockage and quick awakening. Ninety ASA 1 children between 3-15 years will be included the study randomized and prospectively and will be premedicated with midazolam0.5 mg/kg orally. Standard monitoring procedures per the American Society of Anaesthesiologists and train of four (TOF)monitoring will be performed. For induction sevoflurane %8 and N2O-O2 %50 or in children which have vascular access propofol 2-3 mg/kg, fentanyl 1 µg/kg, lidocaine 1 mg/kg and rocuronium 0.6 mg/kg will be administered. Anesthesia will be maintained with sevoflurane and N2O-O2. Dexamethasone 0.1 mg/kg, paracetamol 15 mg/kg and ondansetron 0.1 mg/kg will be applied. When the operation finish, inhalation anaesthetics will be stopped and when TOF is %25, neostigmine 50 µg/kg and atropine 0.20 µg/kg(n=45) or sugammadex 2 mg/kg will be applied randomly (double-blinded). Time between TOF %25-90, total anaesthesia, operation and eye-opening times will be recorded. All will be evaluated with agitation scale (AS) and paediatric anaesthesia emergence delirium (PAED) scale in the recovery room. We will call agitated which had AS>3 and PAED>=10.

Interventions

Using 2 mg/kg single dose sugammadex as an intravenous formula at the end of the surgery . No strategies to monitor about the drug

Sponsors

Semra Gumus Demirbilek
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
3 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

90 children between 3-15 years who had no other additional disease (ASA1) scheduled to undergo adenotonsillectomy

Exclusion criteria

ASA 2 and over Need for a second surgery because of bleeding drug allergies any respiratory tract infection

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026