- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05582005
An Observational Study of Emergence and Hypoactive Delirium After Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The restless recovery from anesthesia is a relevant clinical problem that can be present in up to 80% of surgical cases. The incidence varies with age, anesthetic agents, type of surgery, and definition of the children behavior.
Unsettle behavior after anesthesia is associated with patient injury, damage to incision sites, exacerbated parental anxiety, increased nursing workload and cost of the healthcare system. Moreover, agitated children are seven times more likely to have new-onset separation anxiety, apathy, eating and sleeping problems.
The term early postoperative negative behavior (e-PONB) includes different unsettle behaviors after awakening and differentiates early phase from later postoperative behavioral changes. The more relevant components of e-PONB have been identified as pain and Emergence Delirium (ED).
ED a mental disturbance during the recovery from general anesthesia consisting in hallucinations, delusions and confusion manifested by moaning, restlessness, involuntary physical activity, and thrashing in bed. ED occurs within the first 20 min of recovery from anesthesia and often lasts 5-15 minutes and is self-limited.
The five-item Pediatric Anesthesia Emergence Delirium (PAED) scale is the gold standard to assess ED in the pediatric population. However, the diagnosis of ED may be affected by the concurrent presence postsurgical pain. A recent investigation found that only three of the five items of the PAED are delirium-specific ('Eye contact, 'Awareness of the surroundings', 'Purposeful actions'), whereas the other two ('Restlessness' and 'Inconsolability') are noted. As a consequence, if the child has 'no eye contact' and is 'no aware of surroundings,' emergence delirium should be suspected. On the contrary, a child showing 'Abnormal facial expression,' 'Crying' and being 'Inconsolable,' likely suffers of pain. The ED I and II score have been defined as the sum of the first 3-item (eye contact, purposeful movement, and awareness of surrounding) and the last 2-item scores (restlessness and inconsolability) of the PAED scale, respectively.
In up to 15% of children, however, the discrimination between ED and Pain remains impossible. In nonverbal children, in fact, pain is routinely assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The PAED scale and the FLACC scale overlap on three items ('Inconsolability', 'Purposeful actions' and 'Restlessness'), which may lead to misdiagnose pain or ED.
Moreover, one in four children suffering from ED can present with a hypoactive delirium. Children are quiet, confused and disoriented: they do not make eye contact with the caregiver and may not be aware of their surroundings. Rather than being restless, agitated, and making non-purposeful movements, these children would only make minimal movements when awake, are non-communicative, and do not respond to social interactions. Primarily described in intensive care, hypoactive delirium is less recognized during the emergence from general anesthesia. In children, the Cornell Assessment of Pediatric Delirium (CAP-D) revise scale has been proposed to diagnose hypoactive delirium, but data are limited to one study on postsurgical patients.
In order to properly investigate ED and hypoactive delirium without the interference of concomitant pain, studies should be performed in a context of general anesthesia without any painful interventions. Children receiving general anesthesia for Magnetic Resonance Imaging (MRI) represent the ideal population free of "nociceptive stimulation" to investigate the incidence of ED and hypoactive delirium. However, up to one third of preschool children recovering from general anesthesia after MRI studies may show a FLACC score compatible with pain. Children experiencing ED were three times more likely to be also scored with pain.
In conclusion, children awaking from anesthesia might present different forms of negative behavior after anesthesia, namely ED, hypoactive delirium or pain. The evolution, treatment, prognosis and clinical implications of these conditions are different. There is a real practical need for a bedside tool to differentiate pain, ED and hypoactive delirium.
More recently, heart rate variability (HRV) has been proposed as a surrogate measure of pain and distress. In fact, HRV is affected by the balance between sympathetic and parasympathetic tone, and the high frequency changes of HRV is primarily mediated by and specific to the parasympathetic nervous system. The phenomena of pain, fear, anxiety and intraoperative nociception have proven to be accompanied by changes in HRV1.
The newborn infant parasympathetic evaluation (NIPE) is a non-invasive, standardized continuous measurement of HRV. The cardiac signal is extrapolated from the electrocardiogram and respiratory rate (RR) series are computed between two heart beats, resampled at 8 Hz, mean centered and normalized over a 64-second moving window. A wavelet based high pass filter over 0.15 Hz is applied in order to keep parasympathetic related variations only, which are mainly influenced by the respiratory cycle. The NIPE monitor displays two averaged measurements: the average NIPE (NIPEa) results from the average of NIPE measured over the previous 20 minutes, and current NIPE (NIPEc) results from the average of NIPE measured over the previous 64 seconds. A non-disclosed algorithm derived from the high frequency changes of the HRV calculates a score between 0 and 100, where a score of 0 indicates minimal parasympathetic tone and maximal nociception and a score of 100 indicates maximal parasympathetic tone and minimal nociception. To date, NIPE has shown promising results in the assessment of pain and neonatal comfort. In a recent study performed in postsurgical children at the Montreal Children's Hospital, the NIPE showed a significant correlation with pain but not with ED. Although the explanation remains speculative, it is possible that a some of the criteria of PAED are noyt associated with a variation of the parasympathetic tone (and therefore NIPE).
Should these results be confirmed, NIPE might be helpful to rule out the presence of pain and exclude ED.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Gianluca Bertolizio, MD,FRCPC
- Phone Number: 514586-2674
- Email: gianluca.bertolizo@mcgill.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3C4C9
- Montreal Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children ≤ 3 years old, scheduled for elective MRI.
- Patients whose parents are fluent in French or English.
Exclusion Criteria:
- Intubated patients or have higher oxygen requirements
- Parent/guardian refusal
As this study will be conducted with only one NIPE monitor, and it will be devoted to the patient for about 1 hours, two consecutive patients cannot be enrolled in the study. In this case, the second patient will be considered eligible but excluded, and data will not be collected.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-anesthesia negative behaviors (pain, emergence delirium and hypoactive delirium)
Time Frame: 1 hour
|
Validation of NIPE as a tool to predict and assess post-anesthesia negative behaviors.
|
1 hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-9181
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on noninvasive blood pressure, 3 lead ECG, peripheral oxygen saturation
-
McGill University Health Centre/Research Institute...RecruitingPost Operative PainCanada
-
Henning BundgaardCopenhagen University Hospital at Herlev; Copenhagen University Hospital, HvidovreCompletedCongenital Heart Disease
-
Begoña Garcia ZapirainProvincial Council of Bizkaia; Basque GovernmentCompleted
-
National Taiwan University HospitalRecruitingPain | Fatigue | Arthralgia | Myalgia | Fever | Headache | ChillsTaiwan
-
Xim LimitedPortsmouth Hospitals NHS Trust; Mind Over Matter Medtech LtdCompleted
-
Inonu UniversityCompletedMorbid Obesity | Bariatric Surgery Candidate | Hemodynamic InstabilityTurkey
-
Poznan University of Medical SciencesUnknownGlucose Metabolism Disorders | Hypertension | Obesity | Nutrition Disorders | Metabolic Syndrome | Dyslipidemias | Glucose Intolerance | Overweight and ObesityPoland
-
Erasme University HospitalTerminatedCardiovascular Diseases | Cardiovascular Risk Factor | Sleep Disorder; Breathing-Related | Cardiovascular ComplicationBelgium
-
Guy's and St Thomas' NHS Foundation TrustUniversity of Oxford; Engineering and Physical Sciences Research Council, UKCompleted
-
Hospices Civils de LyonTerminated