Procedural Sedation for Pediatric Patients With Spinal Muscular Atrophy

March 18, 2022 updated by: Feyza Sever, Ankara City Hospital Bilkent

Procedural Sedation for Pediatric Patients With Spinal Muscular Atrophy Undergoing Intrathecal Treatment

Background and Aim: Spinal muscular atrophy (SMA) is a neuromuscular disease characterized by progressive symmetrical weakness and atrophy of proximal muscles causing from degeneration of anterior horn cells of spinal cord. Nusinersen must be administered intrathecally and this treatment is specially for spinal muscular atrophy. Procedural sedation is commonly enough for intrathecal treatment in children. In this retrospective study, the investigators aimed to present our experience in procedural sedation for the intrathecal treatment of patients with SMA 1,2 and 3 in our hospital.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Design: This research is a retrospective obsevational study. Methods: After approval Institutional Review Board, data from anesthesia charts and electronic medical records of 14 patients with SMA type I, II and III who underwent procedural sedation,such as; the demographics data of the patients (age, gender, weight, American Society of Anesthesiologist (ASA) Physical Status), which anesthetic agent was used and their doeses, during of anesthesia, presence of scoliosis, by whom the procedure was performed etc. was reviewed. All our patients with SMA type II and III who underwent intrathecal treatment are given sedation with different combination of anesthetic agent. Due to peripheral intravenous line was placed previously, intravenous induction was performed in all of our patients For procedural sedation, anesthesiologists used different combination of midazolam, ketamine, propofol, fentanyl or remifentanyl, depending on the patient's requirement. They were oxygenated with a face mask or nasal cannula while their spontaneous breathing continues. All patients were recovered in the recovery room.

Statistical analysis: The data were analyzed by using SPSS Statistics Software (SPSS 24, Chicago, IL, USA) Descriptive statistics were used in this study. Mean and standart deviation were calculated for Age (year), Weight (kilogram), Midazolam Dose (mg/kg), Fentanyl Dose (mcg/kg), Remifentanyl Dose (mcg/kg), Propofol Dose (mg/kg), Ketamine Dose (mg/kg) and Length of Stay in Recovery Room (minute) and frequency analysis were made for the number of intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06800
        • Feyza Sever

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric patients younger than 18 years old with SMA 1,2 and 3 who were to undergo intrathecal treatment under procedural sedation in our clinic

Description

Inclusion Criteria:

  • Pediatric patients younger than 18 years old with SMA 1,2 and 3 who were to undergo intrathecal Nusinersen treatment were included in this study.

Exclusion Criteria:

  • Patients whose procedures were performed under fluoroscopic guidance in the radiology unit were excluded from the study because their procedures were performed in another hospital.
  • Patients without a diagnosis of SMA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Procedural sedation
Time Frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
The number of pediatric patients with SMA I,II and III who underwent intrathecal treatment required procedural sedation
4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Anesthetics use
Time Frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
The anesthetic agents and their doses that used during procedure
4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Age
Time Frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Age in year
4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Gender
Time Frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Gender as female/male
4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Weight
Time Frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Weight in kilograms
4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
American Society of Anesthesiologists (ASA) physical status
Time Frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
ASA score
4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Type of SMA
Time Frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
SMA I, SMA II and SMA III
4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Presence of scoliosis
Time Frame: 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)(
Yes or no
4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)(
How many times intrathecal treatment was performed for each patient
Time Frame: 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
The number of intrathecal treatments was administered for each patient over 4 years was recorded.
4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
By whom the procedure was performed
Time Frame: 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
It was recorded who performed the lumbar puncture procedure from a neurologist, neurosurgeon, or anesthesiologist.
4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Length of time spent in recovery room
Time Frame: 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Recovery time in minutes
4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-159

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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