A Phase 4 interventional study of Propofol and Propofol in Delirium on Emergence, sponsored by State University of New York at Buffalo. Terminated at 1 site in United States. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by State University of New York at Buffalo · Phase 4, Interventional, and Prevention
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.
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.
788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
This study's enrollment of 6 is below the median of 120 across 491 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
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
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 · Drug: Sevoflurane
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
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 · Drug: Isoflurane
Propofol infusion with nasal oxygen
Also known as: Diprivan 1%
Propofol infusion with an LMA
Also known as: 1% Diprivan
Sevoflurane with an LMA
Also known as: Sevorane
Isoflurane with an LMA
Also known as: Forane
Incidence of Delirium on Emergence
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.
Time frame: WIthin 2 hours of emergence from anesthesia
Incidence of Airway Complications
All airway reflex responses including airway obstruction breath holding, coughing, laryngospasm, desaturation \<92% for \>15 s regardless of the cause, bronchospasm, secretions and hiccups
Time frame: WIthin 2 hours of emergence from anesthesia
| Milestone | Sevoflurane, Propofol, Nasal Oxygen | Sevoflurane, Propofol, LMA | Sevoflurane, Sevoflurane, LMA | Sevoflurane, Isoflurane, LMA |
|---|---|---|---|---|
| Started | 0 | 5 | 1 | 0 |
| Completed | 0 | 5 | 1 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Participants | Sevoflurane, Propofol, Nasal Oxygen | Sevoflurane, Sevoflurane, LMA | Sevoflurane, Propofol, LMA | Sevoflurane, Isoflurane, LMA |
|---|---|---|---|---|
| Incidence of Delirium on Emergence | 0 | 1 | 5 | 0 |
All airway reflex responses including airway obstruction breath holding, coughing, laryngospasm, desaturation \<92% for \>15 s regardless of the cause, bronchospasm, secretions and hiccups
| Participants | Sevoflurane, Propofol, Nasal Oxygen | Sevoflurane, Sevoflurane, LMA | Sevoflurane, Propofol, LMA | Sevoflurane, Isoflurane, LMA |
|---|---|---|---|---|
| Incidence of Airway Complications | 0 | 1 | 5 | 0 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sevoflurane, Propofol, Nasal Oxygen | — | — | — |
| Sevoflurane, Sevoflurane, LMA | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Sevoflurane, Propofol, LMA | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Sevoflurane, Isoflurane, LMA | — | — | — |
start study
| Age, Categorical(Participants) | Sevoflurane, Propofol, Nasal Oxygen | Sevoflurane, Propofol, LMA | Sevoflurane, Sevoflurane, LMA | Sevoflurane, Isoflurane, LMA | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 5 | 1 | 0 | 6 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Sevoflurane, Propofol, Nasal Oxygen | Sevoflurane, Propofol, LMA | Sevoflurane, Sevoflurane, LMA | Sevoflurane, Isoflurane, LMA | Total |
|---|---|---|---|---|---|
| Female | — | 3 | 0 | — | 3 |
| Male | — | 2 | 1 | — | 3 |
| Region of Enrollment(participants) | Sevoflurane, Propofol, Nasal Oxygen | Sevoflurane, Propofol, LMA | Sevoflurane, Sevoflurane, LMA | Sevoflurane, Isoflurane, LMA | Total |
|---|---|---|---|---|---|
| United States | — | 5 | 1 | — | 6 |
Plan to share: No
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The record gives a start of Jan 2014, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2019, 4 years 7 months after primary completion.
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This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Propofol · Sevoflurane · Isoflurane
State University of New York at Buffalo →