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

The Severity of Agitation in Adenotonsillectomy in Pediatric Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571867
• Other study ID #: sugammadex
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: June 2018
• Source: Sakarya University
• Contact: Havva Sayhan, Assis Prof
• Phone: +905056621021
• Email: hsayhan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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 blinded of the groups to participate in the study.

Related Conditions & MeSH terms

• Psychomotor Agitation
• The Severity of Agitation in Adenotonsillectomy in Pediatric Patients

Locations

Country	Name	City	State
Turkey	Sakarya University Research and Training Hospital	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	agitation level	Pediatric Anesthesia Emergence Delirium (PAED), which provides a score from 0 to 20	1 month
Secondary	pain levels	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	1 month