VALIDATION OF AN EFFECT-SITE TARGETED PROPOFOL INFUSION FOR ANAESTHESIA IN CHILDREN - EFFECT SITE TARGETED PROPOFOL FOR ANAESTHESIA IN CHILDRE

Phase 1

• Conditions: Children undergoing general anaesthesia; MedDRA version: 14.0 Level: PT Classification code 10021723 Term: Induction and maintenance of anaesthesia System Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2009-014568-21-GB
• Lead Sponsor: HS Greater Glasgow & Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

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

Inclusion Criteria

ASA 1 and 2 healthy male and female children aged 1 to 12 years (inclusive)
Weight 6 – 60 kg
Elective surgery suitable for general anaesthesia with regional blockade, for example herniotomy, ligation of patent processus vaginalis, testicular fixation and hypospadias repair, or minimally stimulating procedures not requiring opiate supplementation, such as endoscopy and radiological investigation or intervention.
Surgery or procedure of expected duration of at least 30 minutes
Written parental consent, or child’s consent if competent, for inclusion
Child appropriate for intravenous induction and maintenance of anaesthesia with propofol
Agreement to undergo intravenous induction of anaesthesia
No contraindication to application of topical local anaesthesia prior to cannulation
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

•Parental refusal, or refusal of child if competent
•Allergy to propofol, or any constituent of propofol
•Sensitivity to adhesive agents, as used in the BIS measurement strip
•Refusal of intravenous induction
•Need for sedative premedication
•Inadequate topical analgesia for intravenous cannulation
•Inability to site intravenous cannula within two attempts

Study & Design

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