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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2022
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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.)
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