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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05641376

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. the study will compare between nebulized and intravenous bolus of dexmedetomidine as a prophylaxis against postanesthetic emergence agitation in children undergoing tonsillectomy, adenoidectomy or adeno-tonsillectomy procedures.

Condition or Disease	Intervention/Treatment	Phase
Emergence Agitation	Drug: Nebulized Dexmedetomidine Drug: Intravenous Dexmedetomidine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nebulized Dexmedetomidine Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia.	Drug: Nebulized Dexmedetomidine Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. Treatment will be stopped when the nebulizer began to sputter. At end of nebulizer administration, they will be observed for 30 min before induction of general anaesthesia. then the children will be transferred to the operation room and will receive intravenous (IV) normal saline 0.9% in 10 ml volume over 10 minutes after anesthesia induction.
Active Comparator: Intravenous Dexmedetomidine Children will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.	Drug: Intravenous Dexmedetomidine Children will receive nebulized 3 ml of 0.9% normal saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. then the children will be transferred to the operation room and will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.

Arm

Intervention/Treatment

Active Comparator: Nebulized Dexmedetomidine

Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia.

Drug: Nebulized Dexmedetomidine

Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. Treatment will be stopped when the nebulizer began to sputter. At end of nebulizer administration, they will be observed for 30 min before induction of general anaesthesia. then the children will be transferred to the operation room and will receive intravenous (IV) normal saline 0.9% in 10 ml volume over 10 minutes after anesthesia induction.

Active Comparator: Intravenous Dexmedetomidine

Children will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.

Drug: Intravenous Dexmedetomidine

Children will receive nebulized 3 ml of 0.9% normal saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. then the children will be transferred to the operation room and will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.

Outcome Measures

Primary Outcome Measures

postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale [60 minutes]
Paediatric Anaesthesia Emergence Delirium (PAED) scale will be used to evaluate emergence agitation upon admission to the PACU (0 min, baseline) and at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU. The highest EA scores observed during this period will be recorded. PAED score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation.

Secondary Outcome Measures

Postoperative pain [60 minutes]
Postoperative pain will be recorded using FLACC scale at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU.
emergence agitation (EA) onset [60 minutes]
Emergence agitation onset time was defined as the interval from the extubation to the occurrence.
Emergence Agitation duration [60 minutes]
Emergence agitation duration was the time from Emergence agitation onset to its cessation

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA I and II
Children scheduled for tonsillectomy with or without adenoidectomy with or without myringotomy, and/or tympanostomy tube insertion.

Exclusion Criteria:

Patient's guardian refusal to participate in the study.
Children with Behavioral changes; physical or developmental delay; neurological disorder or psychological disorder.
Children on sedative or anticonvulsant medication.
history of sleep apnea
significant organ dysfunction, cardiac dysrhythmia, congenital heart disease
Known allergy to the study drugs.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Aboulfotouh Mohammed, lecturer of Anesthesia and icu, Assiut University

ClinicalTrials.gov Identifier:

NCT05641376

Other Study ID Numbers:

60757593

First Posted:

Dec 7, 2022

Last Update Posted:

Dec 7, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Psychomotor Agitation

Emergence Delirium

Dexmedetomidine

Study Results

No Results Posted as of Dec 7, 2022