Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538584
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Dex - Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Caffeine Facilitates the Recovery of Dexmedetomidine Sedation for MRI in Pediatric Patients a Randomized Double-blinded and Placebo-controlled Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dexmedetomidine Dex a selective α2-adrenergic receptor agonist is the most used sedative for procedural sedation in children and in pediatric Intensive Care Unit PICU because it is associated with less respiratory depression and also less neurotoxicity rather Dex appears neuroprotective Unfortunately Dex is associated with very long emergence times and may cause bradycardia and hypotension However using sedation dosing guidelines by consensus among SPS members 1-3 mcgkg bolus and a 1-2 mcgkghour infusion hemodynamic compromise is less significant and rarely requires intervention in these patients With this Dex sedation protocol these pediatric patients usually take an average of 45 minutes 30-60 minutes to wake and become alert and up to 2 hours to be discharged
Without reversal agents emergence times from Dex sedation are slow The prolonged recovery after Dex sedation for non-surgical procedures negatively affects throughput thus increasing the cost of care Patient safety and satisfaction suffer as a result The children wake feeling tired and sluggish The children dont feel back to normal for an extended period of time which is not surprising given that the half-life for Dex metabolism in 2-3 hours in humans However using sedation dosing guidelines by consensus among SPS members 1-3 mcgkg bolus and a 1-2 mcgkghour infusion hemodynamic compromise is less significant and rarely requires intervention in these patients In humans it has been found that caffeine at 75 mgkg 15 mg caffeine citrate equivalent to 75 mg caffeine base sped emergence from isoflurane anesthesia with minimal hemodynamic effects in healthy human volunteers
The goal of this clinical trial is to determine whether caffeine will facilitate the recovery of Dex sedation after a Magnetic Resonance Imaging MRI procedure by measuring the time from the end of Dex infusion to the time meeting the discharge criteria
Without reversal agents emergence times from Dex sedation are slow The prolonged recovery after Dex sedation for non-surgical procedures negatively affects throughput thus increasing the cost of care Patient safety and satisfaction suffer as a result The children wake feeling tired and sluggish The children dont feel back to normal for an extended period of time which is not surprising given that the half-life for Dex metabolism in 2-3 hours in humans However using sedation dosing guidelines by consensus among SPS members 1-3 mcgkg bolus and a 1-2 mcgkghour infusion hemodynamic compromise is less significant and rarely requires intervention in these patients In humans it has been found that caffeine at 75 mgkg 15 mg caffeine citrate equivalent to 75 mg caffeine base sped emergence from isoflurane anesthesia with minimal hemodynamic effects in healthy human volunteers
The goal of this clinical trial is to determine whether caffeine will facilitate the recovery of Dex sedation after a Magnetic Resonance Imaging MRI procedure by measuring the time from the end of Dex infusion to the time meeting the discharge criteria
Detailed Description:
SCREENING DAY -1-3 - PRIOR TO APPOINTMENT Only a single visit will take place prior to the MRI scan procedure This will be done one to three days prior to the sedation procedure via chart screening or on the day of the sedation and MRI procedure if the advanced review is not possible
Once potentially appropriate subjects have been identified from the OR schedule for the next day the study team will contact the anesthesia provider resident CRNA attending who is scheduled to treat that patient and explain to himher about the research project and ask them to use a Sedline Brain Function Monitor for the case
Sedation team calls patient family with reminder about appointment and NPO instructions
Research pharmacy notified about potential patients
DAY 0 - APPOINTMENT DAY On the day of the Magnetic Resonance Imaging MRI procedure in the preoperative holding area
Study consent orand assent obtained by study team in the pre-sedation area
Study team notifies research pharmacy to preparedeliver study drug
PRE-SEDATION
Patient arrives in sedation suite
RN rooms patient obtains vitals height weight heart rate respiratory rate blood pressure 3-lead electrocardiogram EKG and temperature reviews allergies and asks health-related questions
Physician MD called to room to complete patient history physical examination and reviewsign sedation consent
Sedation physician reviews sedation plan with nurse
The sedation physician will be delegated by the Principal Investigator PI and be Institutional Review Board IRB-approved on this study to provide the study drug
Sedation physician enters HPorders while nurse starts the peripheral IV PIV and prepares sedation medication
Sedation physician returns to bedside for induction In explaining the research project to anesthesia providers the study team will stress the importance of keeping the patients Sedline Density Spectral Array DSA between 8-15 orand Patient State Index PSI reading between 25-50 throughout the course of the case in the subjects who are randomly selected in the monitoring group If BP or HR is over 25-30 baseline an opioid or other pain medications will be used first before increasing the dose of inhalational agent or propofol If BP is low and PSI is on the low end study team will lower the inhalational agent or propofol first If the patient moves and BP and PSI are within the ranges muscle relaxant may be given first unless the use of muscle relaxant is not allowed for the surgical reason If both opioids and muscle relaxant adjustment fail to achieve the hemodynamic stability and immobility goal then the study team will adjust the doses of inhalational agent or propofol
Time out performed
SEDATION The anesthesia provider will apply a Sedline Monitor to their forehead during the general anesthesia procedure The anesthesia provider may use the data from the monitor to affect their anesthetic administration or may cover the data from the monitor and only use conventional measures to guide anesthetic dosing in these control cases blood pressure heart rate body movement respiratory rate MAC of inhalational agent depending on what group into which the patient has been randomized
Start induction with Dex 3mcgkg bolus of dexmedetomidine over 10 minutes followed by a Dex infusion of 2mcgkgminute
Nasal cannula with ETCO2 placed
Transport checklist O2 tank full Bag mask at head of bed Airway bag meds transport monitor with battery suction emergency med bag completed only if MRI outside of Comer
Patient transported to MRI
Patient is placed on MRI table monitors switched for MRI compatible monitors If additional medication is required for induction or movement artifact on MRI imaging propofol boluses or in rare cases fentanyl boluses may be given as needed per standard sedation protocol All sedation medications are documented in the medical record per protocol
If BP or HR is over 25-30 baseline an opioid or other pain medications will be used first before increasing the dose of inhalational agent or propofol If BP is low and PSI is on the low end study team will lower the inhalational agent or propofol first If the patient moves and BP and PSI are within the ranges muscle relaxant may be given first unless the use of muscle relaxant is not allowed for the surgical reason If both opioids and muscle relaxant adjustment fail to achieve the hemodynamic stability and immobility goal then the study team will adjust the doses of inhalational agent or propofol
MRI Scan completed
Dex stopped and the time recorded Dex infusion should continue until MRI completion but weaning of Dex is allowed if deemed clinically appropriate Weaning of Dex will be documented in the medical record as per sedation protocol
RECOVERY
After MRI is completed patient is placed back on transport bed and monitors exchanged for transport monitors
Patient transported back to sedation suite for recovery
Sedline monitor is placed on patient
After 2-3 minutes of recording patient receives study drug caffeine citrateplacebo at 10mLkg over 5 minutes
Registered Nurse RN monitors patient per routine sedation protocol every 5min vitals Patient Sedation State Score PSSS score
Study team records time to awake
Sedline monitor may be removed after patient is awake Once the general anesthesia procedure is over and the patient is recovering in PICU the study team will meet with each patient and parent again and use a standardized survey to ask about their satisfaction with their anesthetic including questions about their post-operative pain and feelings of nausea or presence of vomiting They should also be awake be able to drink clear liquid void and ambulate before discharge home with their parents
Study team records time to meet discharge criteria
Patient discharged per routine protocol
FOLLOW-UP DAY 1 AFTER SEDATED MRI
Patient receives call from sedation scheduler the next day per sedation team protocol
Patient receives call from study team the next day via the standardized post-operative survey The study team will follow-up the next day with each patients parent via phone call and ask the same survey questions to ensure resolution of their symptoms and timing of the resolution of their symptoms
Once potentially appropriate subjects have been identified from the OR schedule for the next day the study team will contact the anesthesia provider resident CRNA attending who is scheduled to treat that patient and explain to himher about the research project and ask them to use a Sedline Brain Function Monitor for the case
Sedation team calls patient family with reminder about appointment and NPO instructions
Research pharmacy notified about potential patients
DAY 0 - APPOINTMENT DAY On the day of the Magnetic Resonance Imaging MRI procedure in the preoperative holding area
Study consent orand assent obtained by study team in the pre-sedation area
Study team notifies research pharmacy to preparedeliver study drug
PRE-SEDATION
Patient arrives in sedation suite
RN rooms patient obtains vitals height weight heart rate respiratory rate blood pressure 3-lead electrocardiogram EKG and temperature reviews allergies and asks health-related questions
Physician MD called to room to complete patient history physical examination and reviewsign sedation consent
Sedation physician reviews sedation plan with nurse
The sedation physician will be delegated by the Principal Investigator PI and be Institutional Review Board IRB-approved on this study to provide the study drug
Sedation physician enters HPorders while nurse starts the peripheral IV PIV and prepares sedation medication
Sedation physician returns to bedside for induction In explaining the research project to anesthesia providers the study team will stress the importance of keeping the patients Sedline Density Spectral Array DSA between 8-15 orand Patient State Index PSI reading between 25-50 throughout the course of the case in the subjects who are randomly selected in the monitoring group If BP or HR is over 25-30 baseline an opioid or other pain medications will be used first before increasing the dose of inhalational agent or propofol If BP is low and PSI is on the low end study team will lower the inhalational agent or propofol first If the patient moves and BP and PSI are within the ranges muscle relaxant may be given first unless the use of muscle relaxant is not allowed for the surgical reason If both opioids and muscle relaxant adjustment fail to achieve the hemodynamic stability and immobility goal then the study team will adjust the doses of inhalational agent or propofol
Time out performed
SEDATION The anesthesia provider will apply a Sedline Monitor to their forehead during the general anesthesia procedure The anesthesia provider may use the data from the monitor to affect their anesthetic administration or may cover the data from the monitor and only use conventional measures to guide anesthetic dosing in these control cases blood pressure heart rate body movement respiratory rate MAC of inhalational agent depending on what group into which the patient has been randomized
Start induction with Dex 3mcgkg bolus of dexmedetomidine over 10 minutes followed by a Dex infusion of 2mcgkgminute
Nasal cannula with ETCO2 placed
Transport checklist O2 tank full Bag mask at head of bed Airway bag meds transport monitor with battery suction emergency med bag completed only if MRI outside of Comer
Patient transported to MRI
Patient is placed on MRI table monitors switched for MRI compatible monitors If additional medication is required for induction or movement artifact on MRI imaging propofol boluses or in rare cases fentanyl boluses may be given as needed per standard sedation protocol All sedation medications are documented in the medical record per protocol
If BP or HR is over 25-30 baseline an opioid or other pain medications will be used first before increasing the dose of inhalational agent or propofol If BP is low and PSI is on the low end study team will lower the inhalational agent or propofol first If the patient moves and BP and PSI are within the ranges muscle relaxant may be given first unless the use of muscle relaxant is not allowed for the surgical reason If both opioids and muscle relaxant adjustment fail to achieve the hemodynamic stability and immobility goal then the study team will adjust the doses of inhalational agent or propofol
MRI Scan completed
Dex stopped and the time recorded Dex infusion should continue until MRI completion but weaning of Dex is allowed if deemed clinically appropriate Weaning of Dex will be documented in the medical record as per sedation protocol
RECOVERY
After MRI is completed patient is placed back on transport bed and monitors exchanged for transport monitors
Patient transported back to sedation suite for recovery
Sedline monitor is placed on patient
After 2-3 minutes of recording patient receives study drug caffeine citrateplacebo at 10mLkg over 5 minutes
Registered Nurse RN monitors patient per routine sedation protocol every 5min vitals Patient Sedation State Score PSSS score
Study team records time to awake
Sedline monitor may be removed after patient is awake Once the general anesthesia procedure is over and the patient is recovering in PICU the study team will meet with each patient and parent again and use a standardized survey to ask about their satisfaction with their anesthetic including questions about their post-operative pain and feelings of nausea or presence of vomiting They should also be awake be able to drink clear liquid void and ambulate before discharge home with their parents
Study team records time to meet discharge criteria
Patient discharged per routine protocol
FOLLOW-UP DAY 1 AFTER SEDATED MRI
Patient receives call from sedation scheduler the next day per sedation team protocol
Patient receives call from study team the next day via the standardized post-operative survey The study team will follow-up the next day with each patients parent via phone call and ask the same survey questions to ensure resolution of their symptoms and timing of the resolution of their symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None