Propofol in Emergence Agitation

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00535613
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emergence Agitation	Drug: Propofol	Phase 4

Detailed Description

Emergence agitation is defined as a mental disturbance during the recovery from general anesthesia. It consists of confusion, disorientation, delusions, and hallucinations. It manifests in children as some combination of restlessness, moaning, inconsolable crying, involuntary physical activity, and thrashing about. This puts patients at risk of injuring themselves or their caregivers, causing bleeding or disruption of their surgical repair, and pulling out IVs and drains. It can be difficult to maintain necessary vital sign monitoring in these agitated patients, and constant one-on-one nursing is often required. When emergence agitation occurs, all members of the healthcare team, and the parents report dissatisfaction with the quality of the child's recovery from anesthesia.

Propofol is a commonly used intravenous anesthetic agent. Studies have compared continuous infusions of intravenous propofol versus inhalational sevoflurane for the maintenance of anesthesia. These have shown a significant decrease in the incidence of emergence agitation in the patients who received the propofol infusions. This proposed study will investigate the effects of a single bolus dose of propofol at the conclusion of a sevoflurane inhalational anesthetic.

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does a Single Dose of Propofol Decrease the Incidence of Emergence Agitation in Children?
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 propofol	Drug: Propofol; IV, single bolus at completion of anesthetic, 0.1 ml/kg
Sham Comparator: 2 no propofol	Drug: Propofol; IV, single bolus at completion of anesthetic, 0.1 ml/kg

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Emergent Agitation [up to 30 min post surgery]

   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)

Secondary Outcome Measures

1. Time Spent in Recovery Room [up to 1 hour post surgery]

2. Number of Participants Who Received Medication in the Recovery Room [up to 1 hour post surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univeristy of Wisconsin - Madison	Madison	Wisconsin	United States	53726

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: Cari Meyer, MD, Univeristy of Wisconsin - Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00535613
• Other Study ID Numbers: H-2007-0069
• First Posted: Sep 26, 2007
• Last Update Posted: Oct 21, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psychomotor Agitation; Emergence Delirium; Propofol

Study Results

Participant Flow

Arm/Group Title	Propofol	Placebo
Arm/Group Description	Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg	No propofol
Period Title: Overall Study
STARTED	49	50
COMPLETED	49	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Propofol	Placebo	Total
Arm/Group Description	Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg	No propofol	Total of all reporting groups
Overall Participants	49	50	99
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	1.88	1.72	1.80
Sex: Female, Male (Count of Participants)
Female	2 4.1%	2 4%	4 4%
Male	47 95.9%	48 96%	95 96%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	49 100%	50 100%	99 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Emergent Agitation
Description	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)
Time Frame	up to 30 min post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol	Placebo
Arm/Group Description	Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg	No propofol
Measure Participants	49	50
Count of Participants [Participants]	16 32.7%	24 48%

2. Secondary Outcome

Title	Time Spent in Recovery Room
Time Frame	up to 1 hour post surgery

Outcome Measure Data

Analysis Population Description

The study team planned to collect post anesthesia care unit discharge time from the subject medical records, however PACU discharge time was often not recorded in routine cases during the study period. This was not anticipated by the study team and retrospective analysis was not possible for this outcome.

Arm/Group Title	Propofol	Placebo
Arm/Group Description	Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg	No propofol
Measure Participants	0	0

3. Secondary Outcome

Title	Number of Participants Who Received Medication in the Recovery Room
Time Frame	up to 1 hour post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol	Placebo
Arm/Group Description	Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg	No propofol
Measure Participants	49	50
Count of Participants [Participants]	3 6.1%	6 12%

Adverse Events

Time Frame	Up to 30 min post surgery
Arm/Group Title	Propofol		Placebo
Arm/Group Description	Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg		No propofol
All Cause Mortality
	Propofol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/50 (0%)
Serious Adverse Events
	Propofol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Propofol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.