Anaesthesia with dexmedetomidine and fentanyl for surgery in newborn babies

• Register: ISRCTN
• Last refreshed on: 19 March 2018
• Main ID: ISRCTN11031435
• Date of registration: 10/01/2017
• Prospective Registration: Yes
• Primary sponsor: Uppsala County Council
• Public title: Anaesthesia with dexmedetomidine and fentanyl for surgery in newborn babies
• Scientific title: Anaesthesia with dexmedetomidine and fentanyl for neonatal surgery: A pilot study
• Date of first enrolment: 01/03/2017
• Target sample size: 12
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11031435
• Study type: Observational
• Study design: Interventional non-randomised pilot study (Treatment)
• Phase: Phase II

Countries of recruitment

Sweden

Contacts

• Name: Peter Frykholm

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Anaesthesia
Surgery
Anaesthesia

Intervention(s)

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 microgram/kg and atracurium 0.5 mg/kg at induction, with repeat doses at the start of surgery and if indicated due to a long procedure, and sevoflurane up to 1%.

In the second stage, four patients receive anaesthesia with a low dose of dexmedetomidine initially replacing sevoflurane. At induction, dexmedetomidine 0.4 microgr/kg bolus, then 0.6 microgr/kg/h maintenance with a possibility to titrate to max 1 micrograms/kg/h. Sevoflurane is given only as a "rescue" medication, if the anaesthesia is judged to be inadequate.

After completion of the second stage, an interim analysis is performed. If there were no serious adverse events (hypotension or bradycardia needing intervention with adrenaline or hypoglycaemia needing repeated interventions with glucose administration), and at least two anaesthetics could be completed without sevoflurane, the study is continued with the third stage.

In the third stage, four patients receive the same protocol as in stage two but with a higher dexmedetomidine dose of: bolus 0.7 microgr/kg, maintenance 1 microgr/kg/h, with possible titration up to 2 microgr/kg/h.

Incidence of adverse events is monitored for 24 hours after surgery in all participants.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

NEODEX2

2016-004264-19

Source(s) of Monetary Support

Uppsala County Council

Ethics review

Status:
Approval date:
Contact:

Uppsala IRB, 05/04/2017, ref: Dnr 2017/012

Results

• Results available: Yes
• Date Completed: 31/03/2018