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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2018-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dexmedetomidine Versus Magnesium Infusion in Reducing Agitations in Pediatric Patients Undergoing Adenotonsillectomy

NCT05164627

Postoperative Agitations in Pediatric Patients

UNKNOWN NA

Nebulized Versus Intravenous Dexmedetomidine for Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy

NCT05641376

Emergence Agitation

UNKNOWN NA

Oral Dexmedetomidine for Parental Separation in Pediatrics Undergoing Adenotonsillectomy

NCT03551067

Adenotonsillectomy

COMPLETED PHASE4

Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children

NCT02720705

Agitation

COMPLETED PHASE2/PHASE3

Perioperative Respiratory Adverse events_sugammadex

NCT05354466

Respiratory Complication

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

The Severity of Agitation in Adenotonsillectomy in Pediatric Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No