Anesthesia with dexmedetomidine for surgery in newborn babies. Does it work?

Phase 1

Conditions: The state of anesthesia intraoperatively and pain postoperatively
Therapeutic area: Body processes [G] - Physical Phenomena [G01]

Registration Number: EUCTR2016-004264-19-SE

Lead Sponsor: ppsala County Council

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Neonate admitted to the neonatal intensive care unit
2. Neonate scheduled for abdominal or thoracic surgery requiring anesthesia
3. Plan for delayed extubation in the neonatal intensive care unit with morphine as analgesia
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Planned extubation in the operating room
2. Hemodynamic instability requiring inotropes preoperatively
3. Body weight < 2 kg
4. Patient gestational age <37 weeks or > 44 weeks
5. On-going treatment with alpha-2-agonist, or such treatment discontinued within 12 hours from the start of the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the feasibility of using dexmedetomidine as an alternative to sevoflurane together with high dose fentanyl for neonatal anesthesia;Secondary Objective: 1. To evaluate the indicence of adverse events related to dexmedetomidine infusion in neonatal surgeyr.<br>2. To evaluate if dexmedetomidine has opioid-sparing effects if continued after surgery in neonates.;Primary end point(s): The primary endpoint is completion of the anesthesia and surgery without the use of rescue anesthesia with sevoflurane or propofol and without the occurrence of serious adverse events.;Timepoint(s) of evaluation of this end point: At the end of the anesthetic, at handover to the NICU team.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence of adverse events:<br>changes in blood pressure > 20% from baseline, incidence of heart rate < 100 bpm. <br>2. Postoperative opioid consumption during postoperative day 0, 1 and 2, respectively, compared with matched historical controls.<br>;Timepoint(s) of evaluation of this end point: 48 hours after handover to NICU team