Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

Phase 4

Not yet recruiting

• Conditions: Sedation; Emergence Delirium
• Interventions: Drug: Nebulization of dexmedetomidine and ketamine; Drug: Nebulization of dexmedetomidine

• Registration Number: NCT05821972
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-20
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25
• Study Start: 2023-05-15
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized dexmedetomidine and ketamine	Nebulization of dexmedetomidine and ketamine	Pre-operative nebulization of dexmedetomidine and ketamine
Nebulized dexmedetomidine	Nebulization of dexmedetomidine	Pre-operative nebulization of dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Sedation level using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S)	Pre-operative	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

Name	Time	Method
Emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scale	Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.	It ranges from 0 to 20. PAED score \> 12 indicates the presence of emergence delirium with high sensitivity and specificity.
Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)	Pre-operative	It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt