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NCT03791879
Caudal Dexmedetomidine Analgesia in Pediatrics .
NA trial testing Caudal dexamedatomidine analgesia in 164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block in 164 participants. Completed in 15 October 2020.
1 October 2020
Quick facts
| Lead sponsor | Mansoura University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 164 |
| Start date | 1 January 2019 |
| Primary completion | 1 October 2020 |
| Estimated completion | 15 October 2020 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Caudal dexamedatomidine analgesia — full drug profile →
Conditions studied
- 164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block — all drugs for 164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block →
Sponsor
Mansoura University
Who can join
Adults 1 to 8, male only, with 164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine \>1 µg/kg could not add more analgesic \& stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression). The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects\& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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 NCT03791879 (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 Mansoura University
- Last refreshed: 1 March 2021
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