Anaesthesia with dexmedetomidine and fentanyl for surgery in newborn babies

Phase 2

Completed

• Conditions: Anaesthesia; Surgery

• Registration Number: ISRCTN11031435
• Lead Sponsor: ppsala County Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-10
• Last Update Posted: 19 March 2018
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

1. Extubation planned in the operation theatre
2. Haemodynamic instability requiring inotropic support
3. Weight < 2 kg.
4. Gestational age < 37 weeks or > 44 weeks
5. Treatment with alpha-2-agonist within 12 hours before surgery

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Incidence of adverse events is assessed 24 hours after the end of surgery<br>2. Postoperative opioid consumption is assessed 24 hours after the end of surgery<br>3. Postoperative pain is assessed using N-PASS four-hourly until 24 hours after the end of surgery