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NCT04598061: RACHI_dex
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
trial testing Dexmedetomidine IV in Newborns in 210 participants. Status unknown.
1 October 2023
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 210 |
| Start date | 1 October 2020 |
| Primary completion | 1 October 2023 |
| Estimated completion | 28 November 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Dexmedetomidine IV — full drug profile →
Conditions studied
- Newborns — all drugs for Newborns →
- Infant — all drugs for Infant →
- Spinal Anesthesia — all drugs for Spinal Anesthesia →
Sponsor
University Hospital, Montpellier
Who can join
Eligibility, any sex, with Newborns or Infant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
* Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia. * Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure. * The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery * Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist. * Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner. * The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04598061
- Europe PMC full search
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Related trials
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Trials testing the same drug.
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Other recruiting trials for Newborns
Currently open trials in the same condition.
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Other University Hospital, Montpellier trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04598061 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 22 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04598061.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing