Evaluation of propofol TCI anaesthesia in infants age 6m-3y. - Propofol TCI in infants

Phase 1

• Conditions: Children undergoing general anaesthesia; MedDRA version: 9.1 Level: LLT Classification code 10021722 Term: Induction and maintenance anaesthesia

• Registration Number: EUCTR2008-005086-55-GB
• Lead Sponsor: HS Greater Glasgow & Clyde and University of Glasgow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Healthy male and female children aged 6m-3y (inclusive)
Weight 7-16kg
Elective surgery of expected duration > /=30 minutes
ASA Grade 1 or 2
Written informed consent from parent
Child suitable for intravenous induction and maintenance of anaesthesia with propofol
Children with no contraindication to application of local anaesthetic cream or gel to the cannulation site for intravenous induction

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Age < 6m or >3y (>36m)
Weight < 7kg or >/=17kg
Children undergoing urgent or emergency surgical procedures
Expected duration of surgery < 30 minutes
ASA Grade 3-5
No written informed consent from parent
Children with difficult venous access
Children who need or wish inhalational induction
Children who will need intermittent positive pressure ventilation along with the use of muscle relaxant
Patients who need sedative premedication
Propofol contraindicated (allergy to propofol or its formula components)
Local anaesthetic cream or gel contraindicated

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified