A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation

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

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-20

Study Completion Date

2027-03-20

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cleft Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group C

Same volume of saline placebo IV at the end of surgery

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type OTHER

Same volume of saline placebo IV at the end of surgery

Group D

Dexmedetomidine IV at the end of surgery

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery

Interventions

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Dexmedetomidine

A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery

Intervention Type DRUG

0.9% saline

Same volume of saline placebo IV at the end of surgery

Intervention Type OTHER

Other Intervention Names

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Precedex Normal saline

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No