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

Phase 4

Completed

• Conditions: Surgical Procedures, Operative
• Interventions: Drug: Dexmedetomidine; Drug: Remifentanil; Drug: Bupivacaine; Drug: Ropivacaine

• Registration Number: NCT02353182
• Lead Sponsor: Murdoch Childrens Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-02-02
• Study Start: 2015-05
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active open label single arm	Remifentanil	Dexmedetomidine- remifentanil- caudal based anaesthetic for lower abdominal/lower extremity surgery. Dexmedetomidine (Precedex): loading dose: 1 mcg/kg over 10 minutes. Infusion: Start 1 mcg/kg/hr; titrate up or down within 50% of starting doses as needed Remifentanil (Ultiva): loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed Caudal- Bupivacaine (Marcaine) 0.175%-0.25% or Ropivacaine (Naropin) 0.2% with dose at discretion of anaesthetist
Active open label single arm	Bupivacaine	Dexmedetomidine- remifentanil- caudal based anaesthetic for lower abdominal/lower extremity surgery. Dexmedetomidine (Precedex): loading dose: 1 mcg/kg over 10 minutes. Infusion: Start 1 mcg/kg/hr; titrate up or down within 50% of starting doses as needed Remifentanil (Ultiva): loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed Caudal- Bupivacaine (Marcaine) 0.175%-0.25% or Ropivacaine (Naropin) 0.2% with dose at discretion of anaesthetist
Active open label single arm	Dexmedetomidine	Dexmedetomidine- remifentanil- caudal based anaesthetic for lower abdominal/lower extremity surgery. Dexmedetomidine (Precedex): loading dose: 1 mcg/kg over 10 minutes. Infusion: Start 1 mcg/kg/hr; titrate up or down within 50% of starting doses as needed Remifentanil (Ultiva): loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed Caudal- Bupivacaine (Marcaine) 0.175%-0.25% or Ropivacaine (Naropin) 0.2% with dose at discretion of anaesthetist
Active open label single arm	Ropivacaine	Dexmedetomidine- remifentanil- caudal based anaesthetic for lower abdominal/lower extremity surgery. Dexmedetomidine (Precedex): loading dose: 1 mcg/kg over 10 minutes. Infusion: Start 1 mcg/kg/hr; titrate up or down within 50% of starting doses as needed Remifentanil (Ultiva): loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed Caudal- Bupivacaine (Marcaine) 0.175%-0.25% or Ropivacaine (Naropin) 0.2% with dose at discretion of anaesthetist

Primary Outcome Measures

Name	Time	Method
Number of participants who need for intervention for light anaesthesia	120 minutes (duration of surgery)	Rescue treatment for light anaesthesia will be given if hypertension MAP \> 80 mmHg (confirmed with repeated measure) and/or patient movement.

Secondary Outcome Measures

Name	Time	Method
Number of participants who have pain after anaesthesia	End of surgery until discharge from PACU ( average 1-4 hours)	FLACC (Face, Legs, Activity, Cry, Consolability) scale. The scale is scored in a range of 0-10 with 0 representing no pain.
Number of participants who have respiratory complications	Start of anaesthesia until discharge from PACU (average 1-4 hours)	Any episode of coughing, oxygen desaturation \<90%, breath holding \> 15 seconds
Number of participants who require rescue analgesia in PACU	End of surgery until discharge from PACU (average 1-4 hours)	Analgesia: morphine 0.025-0.05 mg/kg IV for analgesia; repeat 20 minutes. Analgesia thereafter as per local protocol
Number of participants who need for intervention for haemodynamic changes	120 minutes (duration of surgery)	1. Rescue treatment for mild Hypotension will be given if MAP is between 40 mmHg and \<50 mmHg (confirmed with repeated measure); 2. Moderate Hypotension will be defined as MAP \<40 mmHg; 3. Mild bradycardia will be defined as HR \<100 bpm for over one minute; 4. Significant bradycardia will be defined as \<70 bpm over one minute
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)

Trial Locations

Locations (6)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Royal Children's Hospital; 🇦🇺 Parkville, Victoria, Australia

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States