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NCT Number: NCT05291962

Procedural Sedation for Pediatric Patients With Spinal Muscular Atrophy

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.

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Key information

Conditions

Muscular Atrophy, Spinal Anesthesia Central Nervous System Diseases Child, Only Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Feyza Sever

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective observational study

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. Age

    Time frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)

    Age in year

  4. Gender

    Time frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)

    Gender as female/male

  5. Weight

    Time frame: 4 years (The data of the patients were retrospectively analyzed between July 2017 and December 2021.)

    Weight in kilograms

  6. 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

  7. 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

Secondary outcomes

  1. Presence of scoliosis

    Time frame: 4 years The data of the patients were retrospectively analyzed between July 2017 and December 2021.)(

    Yes or no

  2. 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.

  3. 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. 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

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2022
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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