Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI

• ClinicalTrials.gov Identifier: NCT02111447
• Recruitment Status: Terminated
• First Posted: April 11, 2014
• Results First Posted: July 23, 2019
• Last Update Posted: July 23, 2019
• Sponsor: State University of New York at Buffalo
• Information provided by (Responsible Party): Jerrold Lerman, State University of New York at Buffalo

Study Description

Brief Summary:

Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. However, agitation after anesthesia in children may be difficult to distinguish from pain; accordingly studies are ideally designed during MRI to obviate the contribution of pain during emergence. Airway complications have been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs. Whether the airway complications were due to the LMA or the isoflurane was unclear. Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane compared with IV propofol and 2. airway complications after LMA or nasal prongs.

Condition or disease	Intervention/treatment	Phase
Delirium on Emergence	Drug: Propofol; Drug: Sevoflurane; Drug: Isoflurane	Phase 4

Detailed Description:

180 children, ASA physical status 1 or 2 will be recruited for elective MRI scan. Randomized after consent is obtained to one of four groups. Anxiety will be assessed preoperatively using the modified Yale preoperative anxiety scale. Children will be accompanied by one parent to MRI scanner where monitors are applied. All children will have anesthesia induced with nitrous oxide and oxygen followed by sevoflurane until IV is established. Thereupon, they will be managed by their randomization assignment. The propofol pump will be concealed at all times. If propofol was used, it will be disconnected from the patient and residual propofol in the line flushed so prevent unblinding the patient's assignment. A blinded observer will be present to evaluate the patient when emergence begins. The single blinded observer will follow the patient from the MRI scanner through recovery room evaluating vital signs as well as emergence delirium (using the PAED scale). A PAED score > 12 at any time during emergence period will confirm the diagnosis of emergence delirium. After discharge from hospital, a post-discharge questionnaire will be completed at 12, 24 and 48 hours after discharge. All parents will be called to retrieve the questionnaire results after 48 hours after discharge from hospital.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI: Comparative Study Using Propofol, Sevoflurane and Isoflurane
• Study Start Date: January 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sevoflurane, propofol, Nasal oxygen; After securing the IV, sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. A bolus of propofol will not be administered. Oxygen will be delivered via nasal prongs at 2 liters per minute. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min also after 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be administered if the child moves or if signs of light anesthesia are noticed. The propofol infusion may also be increased in response to light anesthesia.	Drug: Propofol; Propofol infusion with nasal oxygen; Other Name: Diprivan 1%; Drug: Propofol; Propofol infusion with an LMA; Other Name: 1% Diprivan
Active Comparator: Sevoflurane, Propofol, LMA; After securing the IV, weight appropriate LMA will be inserted and sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. Oxygen in air will be delivered via LMA. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min after another 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be given if the child moves or exhibits signs of light anesthesia. The propofol infusion may also be increased in response to light anesthesia.	Drug: Propofol; Propofol infusion with nasal oxygen; Other Name: Diprivan 1%; Drug: Sevoflurane; Sevoflurane with an LMA; Other Name: Sevorane
Active Comparator: Sevoflurane, sevoflurane, LMA; After securing the IV, weight appropriate LMA will be inserted and sevoflurane continued at 3% inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. The sevoflurane may be increased or decreased in 0.5% increments as needed.	Drug: Sevoflurane; Sevoflurane with an LMA; Other Name: Sevorane
Active Comparator: Sevoflurane, isoflurane, LMA; After securing the IV, weight appropriate LMA will be inserted , sevoflurane will be discontinued and isoflurane will be administered at 2 % inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. Isoflurane may be increased or decreased in 0.5% increments as needed.	Drug: Sevoflurane; Sevoflurane with an LMA; Other Name: Sevorane; Drug: Isoflurane; Isoflurane with an LMA; Other Name: Forane

Outcome Measures

Primary Outcome Measures :

1. Incidence of Delirium on Emergence [ Time Frame: WIthin 2 hours of emergence from anesthesia ]
   Delirium on emergence will be assessed using the PAED scale by a blinded observer in the post anesthesia period. A score >12 constitutes a diagnosis of delirium in children. The post anesthesia period is usually <2 hours after anesthesia.

Secondary Outcome Measures :

1. Incidence of Airway Complications [ Time Frame: WIthin 2 hours of emergence from anesthesia ]
   All airway reflex responses including airway obstruction breath holding, coughing, laryngospasm, desaturation <92% for >15 s regardless of the cause, bronchospasm, secretions and hiccups

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age 2-12yrs,
• ASA Class I-II,
• Fasting,
• Unmedicated,
• Elective MRI scan

Exclusion Criteria:

• Cognitive impairment,
• On psychotropic medications,
• Taking multiple (>2) antiepileptic medications,
• Requiring endotracheal intubation for GA

Contacts and Locations

Locations

United States, New York

Women and Chidren's Hospital Of Buffalo

Buffalo, New York, United States, 14222

Sponsors and Collaborators

State University of New York at Buffalo

Investigators

• Principal Investigator: Jerrold Lerman, MD; Women And Childrens Hospital Of Buffalo
• Principal Investigator: Christopher Heard, MD; Women And Childrens Hospital Of Buffalo

More Information

• Responsible Party: Jerrold Lerman, Clinical Professor of Anesthesiology, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT02111447
• Other Study ID Numbers: 412889-6
• First Posted: April 11, 2014
• Results First Posted: July 23, 2019
• Last Update Posted: July 23, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Jerrold Lerman, State University of New York at Buffalo:

children; sevoflurane; isoflurane; propofol; anesthesia; MRI; delirium

Additional relevant MeSH terms:

Delirium; Emergence Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Propofol; Sevoflurane; Isoflurane; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation