Clinical trial NCT05291962: Procedural Sedation for Pediatric Patients With Spinal Muscular Atrophy
Official title: Procedural Sedation for Pediatric Patients With Spinal Muscular Atrophy Undergoing Intrathecal Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Atrophy, Spinal
Child, Only
Anesthesia
Keywords: Spinal muscular atrophy
Procedural sedation
Children
Intratechal treatment
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 14
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedural sedation
timeFrame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
measure: Anesthetics use
timeFrame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
measure: Age
timeFrame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
measure: Gender
timeFrame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
measure: Weight
timeFrame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
measure: American Society of Anesthesiologists (ASA) physical status
timeFrame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
measure: Type of SMA
timeFrame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Secondary outcomes:
measure: Presence of scoliosis
timeFrame: 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)(
measure: How many times intrathecal treatment was performed for each patient
timeFrame: 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
measure: By whom the procedure was performed
timeFrame: 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
measure: Length of time spent in recovery room
timeFrame: 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Feyza Sever
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Feyza Sever
role: PRINCIPAL_INVESTIGATOR
References: