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

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.

Study Overview

• Status: Unknown
• Conditions: The Severity of Agitation in Adenotonsillectomy in Pediatric Patients

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Havva Sayhan, Assis Prof; Phone Number: +905056621021; Email: hsayhan@gmail.com
• Study Contact Backup: Name: müge yılmaz, MD; Phone Number: +905056621021; Email: hsayhan@gmail.com

Study Locations

• Turkey
  • Sakarya, Turkey, 54100
    • Recruiting
    • Sakarya University Research and Training hospital
    • Contact: Havva Sayhan, Assis Prof; Phone Number: +905056621021; Email: hsayhan@gmail.com
    • Contact: müge yılmaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inclusion Criteria: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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
group Sugammadex; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sakarya University
• Investigators: Study Chair: Havva Sayhan, Assis Prof, Sakarya University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Adenotonsillectomy; Sugammadex; Severity of Agitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation
• Other Study ID Numbers: sugammadex

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No