Cardiac CatheterizationNCT04258007
Sugammadex Versus Neostigmine in Pediatric Less Than Two Years Undergoing Cardiac Catheterization
A study testing Reversal Neostigmine and Reversal Sugammadex in people with Cardiac Catheterization, run by Mansoura University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Cardiac Catheterization
- What is being tested?
- Reversal Neostigmine and Reversal Sugammadex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jan 2020to 18 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists physical status (ASA) I-III
Who cannot join
- Legal guardian refusal.
- Any patients with known drug hypersensitivity.
- Kidney failure.
- Liver failure.
- Diseases affecting the neuromuscular junction.
- A history of malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery Profile of Sugammadex Versus Neostigmine in Pediatric Patients Undergoing Cardiac Catheterization: a Randomized Double-blind Study
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
Read the detailed description
There are numerous advantages of early tracheal extubation otherwise known as fast-tracking following anesthesia for congenital heart disease (CHD)
Early tracheal extubation not only eliminates the potential morbidity related to an endotracheal tube and mechanical ventilation such as atelectasis, accumulation of secretions, nosocomial infections, and the potential for airway trauma, it also limits the need for sedation and the antecedent adverse effects including respiratory and hemodynamic depression, tolerance, withdrawal, and delirium. Most importantly, the shift from positive pressure to spontaneous ventilation augments cardiovascular function and improves preload. Reversal of neuromuscular blockade is a fundamental aspect of emergence from general anesthesia. Historically, the only option to actively reverse blockade will be to administer anticholinesterase inhibitors, which are unable to reverse deep neuromuscular blockade. They are also associated with a variety of cholinergic side effects, including bradycardia, nausea, and increased secretions, which require concomitant administration of an anticholinergic agent, with its own adverse effects. Sugammadex is a newer, selective relaxant binding agent
- Conditions
- Cardiac Catheterization
- Being tested
- Reversal Neostigmine, Reversal Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reversal NeostigmineDrug
Also called PROSTIGMIN®
Patients will receive 0.02 mg/ kg atropine and 0.04 mg/ kg neostigmine following observing the second response on stimulating the ulnar nerve on the TOF watch
Reversal SugammadexDrug
Also called BRIDION®
Interventional Arm Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch
| Study group | Role | What they receive |
|---|---|---|
| Reversal Neostigmine | Placebo comparator | Patients undergoing cardiac catheterization will receive a combination of 0.02 mg/ kg atropine and 0.04 mg/ kg neostigmine following observing the second response on stimulating the ulnar nerve on the TOF watch Receives: Drug: Reversal Neostigmine |
| Reversal Sugammadex | Active comparator | Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch Receives: Drug: Reversal Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 minutes after endotracheal extubation
Secondary outcomes (9)
Heart rate
Measured: assessed basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal
Mean arterial blood pressure
Measured: basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal
Diastolic arterial blood pressure
Measured: basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal
Peripheral oxygen saturation
Measured: basal, after induction, every 15 min during operation , just before reversal, at 1,2,5,7,10,15 minutes after reversal
vomiting
patients monitored for incidence and rate of vomiting by clinical observation in PACU for 24 hours after sugammadex or neostigmine administration .
Measured: for 24 hour after sugammadex or neostigmine administration
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
Measured: for 24 hour after sugammadex or neostigmine administration
blood glucose
blood glucose in (mg/dL) measured using a GLUCOMETER with strip
Measured: preoperative, 15 minutes before reversal and 30 minutes after reversal
prothrombin time
PT in seconds measured Just before reversal and 60 min after reversal administration.
Measured: intraoperative and for 60 minutes after sugammadex or neostigmine administration
activated prothromboplastin time
APTT in seconds measured Just before reversal and 60 min after reversal administration.
Measured: intraoperative and for 60 minutes after sugammadex or neostigmine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start27 Jan 2020
- Primary completion10 Nov 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif A Mousa, MD, Study chair, Professor of Anaesthesia and Surgical Intensive CareAmgad A Zaghloul, MD, Study director, Associate Professor of Anaesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258007
- Sponsor's protocol ID
- MS.19.08.759
- Status last verified
- Jun 2021
- First submitted
- 28 Jan 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Profile of Sugammadex Versus Neostigmine in Pediatric Patients Undergoing Cardiac Catheterization: a Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT04258007
- Acronym / sponsor ID
- MS.19.08.759
- Conditions
- Cardiac Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
There are numerous advantages of early tracheal extubation otherwise known as fast-tracking following anesthesia for congenital heart disease (CHD)
Early tracheal extubation not only eliminates the potential morbidity related to an endotracheal tube and mechanical ventilation such as atelectasis, accumulation of secretions, nosocomial infections, and the potential for airway trauma, it also limits the need for sedation and the antecedent adverse effects including respiratory and hemodynamic depression, tolerance, withdrawal, and delirium. Most importantly, the shift from positive pressure to spontaneous ventilation augments cardiovascular function and improves preload. Reversal of neuromuscular blockade is a fundamental aspect of emergence from general anesthesia. Historically, the only option to actively reverse blockade will be to administer anticholinesterase inhibitors, which are unable to reverse deep neuromuscular blockade. They are also associated with a variety of cholinergic side effects, including bradycardia, nausea, and increased secretions, which require concomitant administration of an anticholinergic agent, with its own adverse effects. Sugammadex is a newer, selective relaxant binding agent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reversal Neostigmine | Placebo comparator | Drug: Reversal NeostigminePatients undergoing cardiac catheterization will receive a combination of 0.02 mg/ kg atropine and 0.04 mg/ kg neostigmine following observing the second response on stimulating the ulnar nerve on the TOF watch |
| Reversal Sugammadex | Active comparator | Drug: Reversal SugammadexPatients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status (ASA) I-III
Key exclusion criteria (6 listed)
- Legal guardian refusal.
- Any patients with known drug hypersensitivity.
- Kidney failure.
- Liver failure.
- Diseases affecting the neuromuscular junction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reversal NeostigmineAlso: PROSTIGMIN®Patients will receive 0.02 mg/ kg atropine and 0.04 mg/ kg neostigmine following observing the second response on stimulating the ulnar nerve on the TOF watch | Drug | Reversal Neostigmine |
| Reversal SugammadexAlso: BRIDION®Interventional Arm Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch | Drug | Reversal Sugammadex |
Primary outcome
Reversal efficacy
Time frame: 90 minutes after endotracheal extubation
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
9 secondary outcomes
Heart rate
Time frame: assessed basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal
Mean arterial blood pressure
Time frame: basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal
Diastolic arterial blood pressure
Time frame: basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal
Peripheral oxygen saturation
Time frame: basal, after induction, every 15 min during operation , just before reversal, at 1,2,5,7,10,15 minutes after reversal
vomiting
Time frame: for 24 hour after sugammadex or neostigmine administration
Anaphylaxis
Time frame: for 24 hour after sugammadex or neostigmine administration
blood glucose
Time frame: preoperative, 15 minutes before reversal and 30 minutes after reversal
prothrombin time
Time frame: intraoperative and for 60 minutes after sugammadex or neostigmine administration
activated prothromboplastin time
Time frame: intraoperative and for 60 minutes after sugammadex or neostigmine administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: Yes. Following publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif A Mousa, MD study chair
Professor of Anaesthesia and Surgical Intensive Care
Amgad A Zaghloul, MD study director
Associate Professor of Anaesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reversal Neostigmine and Reversal Sugammadex in people with Cardiac Catheterization, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal efficacy (time frame: 90 minutes after endotracheal extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.