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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
NCT02353182 |
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Date of registration:
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26/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.
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Scientific title:
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An Open Label Pilot Study of Feasibility of a Dexmedetomidine-Remifentanil-Caudal Anaesthetic for Infant Lower Abdominal/Lower Extremity Surgery: The TREX Pilot Study |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02353182 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Singapore
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United States
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Contacts
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Name:
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Andrew J Davidson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Murdoch Childrens Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants aged 1 to 12 months (corrected age)
- ASA I or II
- Infants undergoing lower abdominal/lower extremity surgery anticipated to be > 120
minutes in duration
- Surgery requires caudal regional nerve block
Exclusion Criteria:
- ASA III or higher
- Any contraindication to caudal analgesia
- Any contraindication to an inhalational induction with sevoflurane
- Allergies to any medication in study protocol
- Planned admission to an ICU postoperatively (except level II or III neonatal ICU)
- Planned tracheal intubation postoperatively
- Mechanical ventilation postoperatively
Age minimum:
1 Month
Age maximum:
12 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Surgical Procedures, Operative
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Intervention(s)
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Drug: Ropivacaine
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Drug: Bupivacaine
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Drug: Remifentanil
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Drug: Dexmedetomidine
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Primary Outcome(s)
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Number of participants who need for intervention for light anaesthesia
[Time Frame: 120 minutes (duration of surgery)]
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Secondary Outcome(s)
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Number of participants who require rescue analgesia in PACU
[Time Frame: End of surgery until discharge from PACU (average 1-4 hours)]
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Number of participants who need for intervention for haemodynamic changes
[Time Frame: 120 minutes (duration of surgery)]
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Time to recovery after anaesthesia
[Time Frame: Time from last dressing to: eye opening, removal of airway device, first feed, and a modified Aldrete Score of 9-10 (average 30 minutes-4 hours)]
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Number of participants who have pain after anaesthesia
[Time Frame: End of surgery until discharge from PACU ( average 1-4 hours)]
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Number of participants who have respiratory complications
[Time Frame: Start of anaesthesia until discharge from PACU (average 1-4 hours)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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