Clinical Trial Results:
Effect site controlled, reaction time safeguarded, patient maintained sedation with Propofol
A) in oral surgery patients
B) in general dentistry patients
C) in colonoscopy patients
Summary
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EudraCT number |
2005-005758-39 |
Trial protocol |
GB |
Global end of trial date |
11 Feb 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Apr 2019
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First version publication date |
13 Apr 2019
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Other versions |
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Summary report(s) |
2005-005758-39 summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
9812/A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Sponsor reference: WN06AN024 | ||
Sponsors
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Sponsor organisation name |
NHS Greater Glasgow and Clyde
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Sponsor organisation address |
Clinical Research & Development, West Glasgow Ambulatory Care Hospital, Dalnair Street, Glasgow, United Kingdom, G3 8SW
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Public contact |
Dr Debra Stuart, NHS Greater Glasgow and Clyde, debra.stuart@glasgow.ac.uk
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Scientific contact |
Dr Debra Stuart, NHS Greater Glasgow and Clyde, debra.stuart@glasgow.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Apr 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Feb 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Feb 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess whether patient-maintained sedation (the patient controls his/her degree of sedation using a hand-held device) using the drug propofol is safer and more effective when using deteriorating reaction time as an added safeguard against the potential for oversedation in groups of patients undergoing dental surgery and colonoscopy.
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Protection of trial subjects |
The routine use of propofol traditionally is restricted to anaesthetists, as in high doses general anaesthesia is produced with possible loss of airway patency. Currently the safety feature is predominantly that as patients become more sedated they cannot press the patient demand button and hence cannot increase the amount of propofol they are receiving. Also the device ensures that the blood and brain concentrations have equilibrated to within 10% of each other before another successful demand for propofol can be made (usually takes approximately two minutes) and it only allows a maximum calculated brain concentration of 3 micrograms/milliliter of propofol. The device also will start to decrease the calculated brain concentration of propofol if the demand button has not been pressed for six minutes.
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Background therapy |
N/A | ||
Evidence for comparator |
N/A | ||
Actual start date of recruitment |
06 Dec 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
20
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Healthy patients (ASA physical status 1-2) receiving sedation while undergoing oral surgery recruited via NHS clinics in the United Kingdom | ||||||
Pre-assignment
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Screening details |
Inclusion Criteria ASA I-II (healthy or only mild systemic illness) undergoing planned dental surgery or colonoscopy; Age 18-65yrs Exclusion Criteria ASA III or above; Outwith age group above; Contraindication to Propofol; History of epilepsy; History of substance abuse; Major Psychiatric illness; Pregnancy or breastfeeding; Unable to consent | ||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
n/a
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Arms
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Arm title
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Oral Surgery | ||||||
Arm description |
oral surgery patients | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Propofol
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Investigational medicinal product code |
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Other name |
Diprivan
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
1% = 10mg/ml. Target Controlled Infusion (50ml prefilled syringe)
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Baseline characteristics reporting groups
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Reporting group title |
Oral Surgery
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Reporting group description |
oral surgery patients | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Oral Surgery
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Reporting group description |
oral surgery patients |
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End point title |
Minimal sedation level [1] | ||||||||||||||||
End point description |
Observer's Assessment of Alertness Sedation score
Range: 1 (unresponsive) to 5 (fully awake)
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End point type |
Primary
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End point timeframe |
Treatment period
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Pilot single group, prospective, phase IV study; no formal statistical analysis performed. Descriptive statistics only reported. |
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No statistical analyses for this end point |
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End point title |
Time for sedation | ||||||||
End point description |
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End point type |
Post-hoc
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End point timeframe |
Treatment period
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No statistical analyses for this end point |
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End point title |
Maximum propofol effect-site concentration | ||||||||
End point description |
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End point type |
Post-hoc
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End point timeframe |
Treatment period
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No statistical analyses for this end point |
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End point title |
Lowest oxygen saturation | ||||||||
End point description |
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End point type |
Post-hoc
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End point timeframe |
Treatment period
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Initiation of sedation to discharge following the surgical procedure.
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
17
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Reporting groups
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Reporting group title |
Participant group
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events were reported, confirmed by the PI to the CI on 22/08/2007 |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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20 Aug 2008 |
Change of Chief Investigator |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/24044388 |