Cardiac Catheterization Clinical Trial
Official title:
Recovery Profile of Sugammadex Versus Neostigmine in Pediatric Patients Undergoing Cardiac Catheterization: a Randomized Double-blind Study
Verified date | June 2021 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study hypothesizes that Sugammadex may has more appropriate recovery profile than neostigmine in pediatric cardiac patients undergoing cardiac catheterization. In pediatric cardiac patients, clear and rapid recovery (fast-tracking) is required to maintain hemodynamic within the normal physiological values which may be saved by sugammadex
Status | Completed |
Enrollment | 50 |
Est. completion date | November 18, 2020 |
Est. primary completion date | November 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Years |
Eligibility | Inclusion Criteria: - American Society of Anesthesiologists physical status (ASA) I-III Exclusion Criteria: - Legal guardian refusal. - Any patients with known drug hypersensitivity. - Kidney failure. - Liver failure. - Diseases affecting the neuromuscular junction. - A history of malignant hyperthermia |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University | Mansoura | DK |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reversal efficacy | Mean time in minutes from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9 | 90 minutes after endotracheal extubation | |
Secondary | Heart rate | assessed basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal | ||
Secondary | Mean arterial blood pressure | basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal | ||
Secondary | Diastolic arterial blood pressure | basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal | ||
Secondary | Peripheral oxygen saturation | basal, after induction, every 15 min during operation , just before reversal, at 1,2,5,7,10,15 minutes after reversal | ||
Secondary | vomiting | patients monitored for incidence and rate of vomiting by clinical observation in PACU for 24 hours after sugammadex or neostigmine administration . | for 24 hour after sugammadex or neostigmine administration | |
Secondary | Anaphylaxis | patients monitored after sugammadex or neostigmine administration for 24 hours postoperative for The National Institute of Allergy and Infectious Diseases (NIAID) and the Food Allergy and Anaphylaxis
Network (FAAN) proposed clinical criteria for diagnosing anaphylaxis . Depending on the severity of the reaction, four grades of immediate clinical manifestations are described: Grade 1, Cutaneous signs only; Grade 2, Measurable but not life-threatening symptoms and cutaneous signs,hypotension, tachycardia, and respiratory disturbances, such as cough and difficulty in lung inflation; Grade 3, Life-threatening symptoms: collapse, tachycardia or bradycardia, arrhythmias, bronchospasm; Grade 4, Cardiac and/or respiratory arrest |
for 24 hour after sugammadex or neostigmine administration | |
Secondary | blood glucose | blood glucose in (mg/dL) measured using a GLUCOMETER with strip | preoperative, 15 minutes before reversal and 30 minutes after reversal | |
Secondary | prothrombin time | PT in seconds measured Just before reversal and 60 min after reversal administration. | intraoperative and for 60 minutes after sugammadex or neostigmine administration | |
Secondary | activated prothromboplastin time | APTT in seconds measured Just before reversal and 60 min after reversal administration. | intraoperative and for 60 minutes after sugammadex or neostigmine administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05539092 -
The Effect of Changing Angle of Bed on Pain Severity and Vascular Complications Among Cardiac Catheterization Patients
|
N/A | |
Completed |
NCT02074527 -
CHAIN_brazilian Registry of Congenital HeArt Disease INtervention and Angiography
|
||
Completed |
NCT01157338 -
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
|
N/A | |
Terminated |
NCT00850473 -
PET/CT Study in the Diagnosis of Coronary Plaque
|
N/A | |
Completed |
NCT03645837 -
Rapid Clamp Release Post Trans-radial Cardiac Catheterization
|
N/A | |
Completed |
NCT04404257 -
Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation
|
N/A | |
Recruiting |
NCT03555500 -
Fasting or Non Fasting for Cardiac Catheterization
|
N/A | |
Not yet recruiting |
NCT06134141 -
The Outcome of Interventional Cardiac Catheterization In Pediatric Cardiology Unit, Assiut University Heart Hospital
|
||
Recruiting |
NCT05941013 -
Ultrasound-detectable Endotracheal Tube: a Feasibility Study
|
N/A | |
Recruiting |
NCT05632640 -
Post Anesthesia Care Unit (PACU) Weighted Blanket Study
|
N/A | |
Unknown status |
NCT00838175 -
Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access
|
N/A | |
Completed |
NCT03243942 -
Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement
|
Phase 2 | |
Completed |
NCT01155167 -
Topical Radial Artery Vasodilation
|
Phase 2/Phase 3 | |
Withdrawn |
NCT00825331 -
Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)
|
N/A | |
Recruiting |
NCT05225077 -
Short-term Use of Dapagliflozin to Protect Kidney Function in CKD Patients
|
Phase 4 | |
Completed |
NCT05117359 -
Transcatheter Para-Valvular Leak Closures
|
||
Recruiting |
NCT00849940 -
Validation of Brain Oxygenation Monitor on Pediatric Patients
|
N/A | |
Active, not recruiting |
NCT05364463 -
Effect of Reactive Hyperemia and Ultrasound-guided Puncture on the Success Rate of Radial Artery Cannulation (RadialHUS)
|
N/A | |
Completed |
NCT03245255 -
Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
|
Phase 2 | |
Enrolling by invitation |
NCT05628779 -
Evaluating Edge-to-edge Transcatheter Tricuspid Valve Repair in Patients With Severe Symptomatic Tricuspid Regurgitation
|
N/A |