A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation

Assiut University

Status and phase: Enrolling; Phase 3

Conditions: Cleft Palate

Treatments: Drug: Dexmedetomidine; Other: 0.9% saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04928391

17300616

Details and patient eligibility

About

The hypothesis of this study is to investigate and compare the efficacy between the administrations of single intravenous (IV) dose of dexmedetomidine versus normal saline in preventing immediate postoperative agitation in children undergoing cleft palate repair.

Full description

A written informed consent will be taken from the guardian of children.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive the study drug at the end of surgery; a single dose of 0.5 µ/kg IV dexmedetomidine (Group D) or same volume of saline placebo (Group C).

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
• Elective cleft palate repair ± cleft lip surgery under general anesthesia.

Exclusion criteria

• Ventriculo-peritoneal shunt
• Suspected meningitis
• Congenital hydrocephalus
• Clinical signs of suspected increased intracranial pressure
• On treatment for seizures or metabolic diseases
• Children with developmental delay
• Hypersensitivity to dexmedetomidine or nalbuphine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Group D

Experimental group

Description:

Dexmedetomidine IV at the end of surgery

Treatment:

Drug: Dexmedetomidine

Group C

Placebo Comparator group

Description:

Same volume of saline placebo IV at the end of surgery

Treatment:

Other: 0.9% saline