Anesthesia Clinical Trial
Official title:
Procedural Sedation for Pediatric Patients With Spinal Muscular Atrophy Undergoing Intrathecal Treatment
NCT number | NCT05291962 |
Other study ID # | 2019-159 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | January 31, 2022 |
Verified date | March 2022 |
Source | Ankara City Hospital Bilkent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Feyza Sever | Ankara | Çankaya |
Lead Sponsor | Collaborator |
---|---|
Ankara City Hospital Bilkent |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural sedation | 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.) | |
Primary | Anesthetics use | 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.) | |
Primary | Age | Age in year | 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.) | |
Primary | Gender | Gender as female/male | 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.) | |
Primary | Weight | Weight in kilograms | 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.) | |
Primary | American Society of Anesthesiologists (ASA) physical status | ASA score | 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.) | |
Primary | Type of SMA | SMA I, SMA II and SMA III | 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.) | |
Secondary | Presence of scoliosis | Yes or no | 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)( | |
Secondary | How many times intrathecal treatment was performed for each patient | 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.) | |
Secondary | By whom the procedure was performed | 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.) | |
Secondary | Length of time spent in recovery room | Recovery time in minutes | 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.) |
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