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

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-11-30

Brief Summary

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

The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.

Related Clinical Trials

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

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

NCT05641376

Emergence Agitation

UNKNOWN NA

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

NCT05164627

Postoperative Agitations in Pediatric Patients

UNKNOWN NA

Oral Dexmedetomidine for Parental Separation in Pediatrics Undergoing Adenotonsillectomy

NCT03551067

Adenotonsillectomy

COMPLETED PHASE4

ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

NCT01374737

Agitation

UNKNOWN PHASE4

Levobupivacaine vs Levobupivacaine + Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients

NCT04113720

Post-tonsillectomy Analgesia Levobupivacaine

COMPLETED PHASE1/PHASE2

Detailed Description

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

Agitation during the emergence from general anesthesia is a great post-operative problem that often injures the patients themselves and requires the medical staff to restrain and calm them. The predisposing factors for emergence agitation include anesthesia, operation, and patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than halothane, because of the rapid emergence, and its effects on central nervous system inducing convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history, and adjustment disorder of patients are risk factors.

Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric ambulatory surgery.

The investigators designed this study to prove the efficacy of oral dexmedetomidine a selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and parents' satisfaction after sevoflurane anesthesia in tonsillectomy.

Conditions

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

Agitation

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

DEX I

active comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

oral dexmedetomidine

Saline Control

2ml oral 0.9%saline half an hour before operation

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

2ml 0.9% saline administered orally half an hour before induction of anesthesia

DEX II

active comparator receive,1µg/kg dexmedetomidine orally half an hour before operation

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

oral dexmedetomidine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

oral dexmedetomidine

Intervention Type DRUG

saline

2ml 0.9% saline administered orally half an hour before induction of anesthesia

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

precedex 0.9% saline

Eligibility Criteria

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

Inclusion Criteria

* ASA physical status I-II patients
* aged 2-6 years
* patient scheduled for elective tonsillectomy due to recurrent
* chronic tonsillitis

Exclusion Criteria

* patients with known hypersensitivity to medication drugs
* coagulation disorders
* thrombocytopenia
* significant cardiac
* renal
* pulmonary
* hepatic disease

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No