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Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

Primary Purpose

Sedation, Emergence Delirium

Status
Not yet recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Nebulization of dexmedetomidine and ketamine
Nebulization of dexmedetomidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedation focused on measuring dexmedetomidine, Ketamine, Nebulization, Cleft palate, Sedation, Emergence delirium

Eligibility Criteria

12 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with American Society of Anesthesiologists (ASA) physical status I & II who will be scheduled for cleft palate repair surgeries Exclusion Criteria: Parent refusal Allergy to the study drugs Suspected difficult airway Patients with endocrine, renal, hepatic, and cardiac pathology Psychiatric diseases Asthmatic patients.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nebulized dexmedetomidine and ketamine

Nebulized dexmedetomidine

Arm Description

Pre-operative nebulization of dexmedetomidine and ketamine

Pre-operative nebulization of dexmedetomidine

Outcomes

Primary Outcome Measures

Sedation level using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
It ranges from 0 = does not respond to a noxious stimulus, to 6 = Appears alert and awake and responds readily to name spoken in normal tone. the higher scores mean less sedation.

Secondary Outcome Measures

Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)
It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome.
Emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scale
It ranges from 0 to 20. PAED score > 12 indicates the presence of emergence delirium with high sensitivity and specificity.

Full Information

First Posted
April 3, 2023
Last Updated
April 21, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05821972
Brief Title
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
Official Title
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.
Detailed Description
Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth. The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation, Emergence Delirium
Keywords
dexmedetomidine, Ketamine, Nebulization, Cleft palate, Sedation, Emergence delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nebulized dexmedetomidine and ketamine
Arm Type
Experimental
Arm Description
Pre-operative nebulization of dexmedetomidine and ketamine
Arm Title
Nebulized dexmedetomidine
Arm Type
Active Comparator
Arm Description
Pre-operative nebulization of dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Nebulization of dexmedetomidine and ketamine
Intervention Description
Pre-operative nebulization of dexmedetomidine and ketamine
Intervention Type
Drug
Intervention Name(s)
Nebulization of dexmedetomidine
Intervention Description
Pre-operative nebulization of dexmedetomidine
Primary Outcome Measure Information:
Title
Sedation level using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
Description
It ranges from 0 = does not respond to a noxious stimulus, to 6 = Appears alert and awake and responds readily to name spoken in normal tone. the higher scores mean less sedation.
Time Frame
Pre-operative
Secondary Outcome Measure Information:
Title
Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)
Description
It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome.
Time Frame
Pre-operative
Title
Emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scale
Description
It ranges from 0 to 20. PAED score > 12 indicates the presence of emergence delirium with high sensitivity and specificity.
Time Frame
Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with American Society of Anesthesiologists (ASA) physical status I & II who will be scheduled for cleft palate repair surgeries Exclusion Criteria: Parent refusal Allergy to the study drugs Suspected difficult airway Patients with endocrine, renal, hepatic, and cardiac pathology Psychiatric diseases Asthmatic patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma N. Mohamed, M.D.
Phone
+201003633992
Email
fatmanabil2012@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Samar Ah. Abdellah, M.B.B.Ch.
Phone
+201095769703
Email
samarahmed1810@gmail.com
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma N. Mohamed, M.D.
Phone
+201003633992
Email
fatmanabil2012@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Samar A Abdellah
Phone
+201095769703
First Name & Middle Initial & Last Name & Degree
Mohammed Galal, M.D.

12. IPD Sharing Statement

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Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

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