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Anaesthesia with dexmedetomidine and fentanyl for surgery in newborn babies

Anaesthesia with dexmedetomidine and fentanyl for neonatal surgery: A pilot study

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11031435
Enrollment
12
Registered
2017-01-10
Start date
2017-03-01
Completion date
Unknown
Last updated
2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia Surgery Anaesthesia

Interventions

In the first stage of the study, a control group of four patients are subjected to standard anaesthesia monitoring + NIRS and CFM). The anaesthesia is routine anaesthesia based on fentanyl 10 microgra

Sponsors

Uppsala County Council
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Admitted to neonatal intensive care unit 2. Scheduled for major abdominal or thoracic surgery requiring anaesthesia with high dose fentanyl (30 micrograms/kg) 3. Delayed extubation is planned, permitting the use of high dose fentanyl 4. Gestational age 39-44 weeks 5. Aged up to one month old

Exclusion criteria

Exclusion criteria: 1. Extubation planned in the operation theatre 2. Haemodynamic instability requiring inotropic support 3. Weight 44 weeks 5. Treatment with alpha-2-agonist within 12 hours before surgery

Design outcomes

Primary

MeasureTime frame
Rate of completion of anaesthesia without the addition of rescue anaesthetics (propofol or sevoflurane) and with hemodynamic stability is assessed at the end of the surgery when the patient is handed over to the ICU team.

Secondary

MeasureTime frame
1. Incidence of adverse events is assessed 24 hours after the end of surgery 2. Postoperative opioid consumption is assessed 24 hours after the end of surgery 3. Postoperative pain is assessed using N-PASS four-hourly until 24 hours after the end of surgery

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026