Propofol in Emergence Agitation

NCT00535613 | Completed Phase 4 Results FDA Drug

• 1 other identifier: H-2007-0069
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see if a small dose of propofol given intravenously (through a needle into a vein) at the end of anesthesia can make it less likely that children will be agitated as the come out of the anesthetic.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Emergent Agitation

  Incidence of Emergent Agitation is defined as a Paediatric Anaesthesia Emergence Delirium (PAED) score above 10 at any point at the defined protocol time points (recovery, 5, 10, 15, 20, 25, or 30 minutes)

  up to 30 min post surgery

Secondary Outcomes (2)

• Time Spent in Recovery Room

  up to 1 hour post surgery

• Number of Participants Who Received Medication in the Recovery Room

  up to 1 hour post surgery

Study Arms (2)

1

EXPERIMENTAL

propofol

Drug: Propofol

2

SHAM COMPARATOR

no propofol

Drug: Propofol

Interventions

Propofol DRUG

IV, single bolus at completion of anesthetic, 0.1 ml/kg

1; 2

Eligibility Criteria

• Age: 12 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 12 months to 6 years old
• Planned surgery/procedure: The goal is to enroll patients who will not have pain when they awake from anesthesia. We will include patients who are having magnetic resonance imaging (MRI) under anesthesia, or an eye exam under anesthesia. We will also include those patients who are having a surgery in which a regional or caudal block is part of the planned anesthetic. This will be small orthopedic procedures in the lower extremities; or urologic or general surgical procedures below the level of the umbilicus. These patients have been chosen because the regional/caudal block should result in the patient not having pain when they awake from anesthesia.
• (The caudal block is a single epidural injection of local anesthetic that is done when the pediatric patient is under general anesthesia. It is a routine procedure that results in numbness below the level of the umbilicus, and gives relief of pain, for about 8 hours.)
• Examples of orthopedic surgeries include, but are not limited to:
• Removal of an extra digit or syndactyly repair Club foot releases Lower extremity tendon releases or lengthenings Lower extremity tendon transfers Removal of hardware
• Examples of urologic surgeries include, but are not limited to:
• Circumcision or circumcision revision hypospadias repair Chordee repair Orchiopexy Orchiectomy
• Examples of general pediatric surgeries include, but are not limited to:
• Inguinal hernia repair Rectal muscle biopsies Excision of lower extremity or lower abdominal mass Burn scar releases and skin grafting

You may not qualify if:

• Obstructive sleep apnea-Patients with sleep apnea are not ideal candidates for removal of their endotracheal tube or laryngeal mask airway while still somewhat anesthetized. It is preferable to extubate these patients awake.
• Developmental delays-Patients with developmental delays may not interact with their environment, make eye contact, have purposeful actions, or be aware of their surroundings even when at their baseline pre-operatively. It would be difficult to evaluate these features of emergence agitation in children who demonstrate this behavior on a routine basis.
• Psychological disorders-Patients with psychological disorders may have the same issues as those with developmental delays when it comes to evaluating their behavior after anesthesia.
• Egg white allergy-Propofol is contraindicated in patients with egg white allergies due to risk of allergy to the propofol lecithin base.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Univeristy of Wisconsin - Madison

Madison, Wisconsin, 53726, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Cari Meyer
• Organization: University of Wisconsin

cmeyer@wisc.edu

(608) 265-5980

Study Officials

• Cari Meyer, MD

  Univeristy of Wisconsin - Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2007
• First Posted: September 26, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 21, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-10

Locations

US (1)