The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.

Surgical Procedures, Operative Clinical Trial

Official title:

An Open Label Pilot Study of Feasibility of a Dexmedetomidine-Remifentanil-Caudal Anaesthetic for Infant Lower Abdominal/Lower Extremity Surgery: The TREX Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353182
• Other study ID #: 35014
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2015
• Last updated: October 24, 2016
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these findings are relevant to humans but the issue has become a major concern. Recent data have found that monkeys exposed to anaesthesia as infants grow up to have slower learning than those not exposed.

The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.

Description:

Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these findings are relevant to humans but the issue has become a major concern. Recent data have found that monkeys exposed to anaesthesia as infants grow up to have slower learning than those not exposed.

The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.

An alternative anaesthetic regimen comprises a dexmedetomidine-based anaesthetic, augmented with an opioid (remifentanil) and a regional nerve block (such as a caudal).

This open label prospective single arm pilot study will enrol 60 infants aged 1-12 months scheduled for lower limb, urologic, or lower abdominal surgery. After sevoflurane induction, the infants will have a caudal anaesthetic and intravenous dexmedetomidine and remifentanil.

The outcome will be need for intervention for light anaesthesia, intervention for haemodynamic changes and rate of abandoning the protocol. Recovery times will also be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 12 Months

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Procedures, Operative

Intervention

Drug:
• Dexmedetomidine
Loading dose:1 mcg/kg over 10 minutes. Infusion: Start 1-1.5 mcg/kg/hr. Titrate up or down within 50% of starting doses as needed.
• Remifentanil
Loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2-0.5 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed.
• Bupivacaine
Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)
• Ropivacaine
Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Parkville	Victoria
Singapore	KK Women's and Children's Hospital	Singapore
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (16)

Lead Sponsor

Collaborator

Murdoch Childrens Research Institute

Boston Children’s Hospital, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Gaslini Children's Hospital, KK Women's and Children's Hospital, Oregon Health and Science University, Princess Margaret Hospital for Children, Starship Children's Health, Sydney Children's Network, Texas Children's Hospital, The Cleveland Clinic, The Royal Children's Hospital Melbourne, UMC Utrecht, University Hospital, Geneva, University of Texas Southwestern Medical Center

Countries where clinical trial is conducted

United States,  Australia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who need for intervention for light anaesthesia	Rescue treatment for light anaesthesia will be given if hypertension MAP > 80 mmHg (confirmed with repeated measure) and/or patient movement.	120 minutes (duration of surgery)	Yes
Secondary	Number of participants who need for intervention for haemodynamic changes	Rescue treatment for mild Hypotension will be given if MAP is between 40 mmHg and <50 mmHg (confirmed with repeated measure); Moderate Hypotension will be defined as MAP <40 mmHg; Mild bradycardia will be defined as HR <100 bpm for over one minute; Significant bradycardia will be defined as <70 bpm over one minute	120 minutes (duration of surgery)	Yes
Secondary	Time to recovery after anaesthesia		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)	No
Secondary	Number of participants who have respiratory complications	Any episode of coughing, oxygen desaturation <90%, breath holding > 15 seconds	Start of anaesthesia until discharge from PACU (average 1-4 hours)	Yes
Secondary	Number of participants who have pain after anaesthesia	FLACC (Face, Legs, Activity, Cry, Consolability) scale. The scale is scored in a range of 0-10 with 0 representing no pain.	End of surgery until discharge from PACU ( average 1-4 hours)	No
Secondary	Number of participants who require rescue analgesia in PACU	Analgesia: morphine 0.025-0.05 mg/kg IV for analgesia; repeat 20 minutes. Analgesia thereafter as per local protocol	End of surgery until discharge from PACU (average 1-4 hours)	No