Procedural Sedation for Pediatric Patients With Spinal Muscular Atrophy

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05291962
Study type	Observational
Source	Ankara City Hospital Bilkent
Contact
Status	Completed
Phase
Start date	January 1, 2022
Completion date	January 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04279054` - Decreased Neuraxial Morphine After Cesarean Delivery	Early Phase 1
Active, not recruiting	`NCT04580030` - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed	`NCT03640442` - Modified Ramped Position for Intubation of Obese Females.	N/A
Recruiting	`NCT04099693` - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated	`NCT02481999` - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed	`NCT04235894` - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting	`NCT05525104` - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).	N/A
Recruiting	`NCT05024084` - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth	Phase 4
Completed	`NCT04204785` - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions	N/A
Completed	`NCT03277872` - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope	N/A
Terminated	`NCT03940651` - Cardiac and Renal Biomarkers in Arthroplasty Surgery	Phase 4
Terminated	`NCT02529696` - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Terminated	`NCT03704285` - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting	`NCT05259787` - EP Intravenous Anesthesia in Hysteroscopy	Phase 4
Completed	`NCT02894996` - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?	N/A
Completed	`NCT05386082` - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated	`NCT03567928` - Laryngeal Mask in Upper Gastrointestinal Procedures	N/A
Recruiting	`NCT06074471` - Motor Sparing Supraclavicular Block	N/A
Completed	`NCT04163848` - CARbon Impact of aNesthesic Gas

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.