Procedural Sedation for Pediatric Patients With Spinal Muscular Atrophy

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291962
• Other study ID #: 2019-159
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: January 31, 2022

Study information

• Verified date: March 2022
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anesthesia
• Atrophy
• Child, Only
• Muscular Atrophy
• Muscular Atrophy, Spinal

Intervention

Other:
• Retrospective observational study
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.

Locations

Country	Name	City	State
Turkey	Feyza Sever	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

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.)