Onset Time of Thiopental Versus Propofol in the Elderly | NCT00965107

Studies
Onset Time of Thiopental Versus Propofol in the Elderly

NCT00965107

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Mar 9, 2010Estimated

Enrollment

78Estimated

Phase

Phase 4

Conditions

Induction of Anaesthesia
Age

Interventions

Thiopental
Propofol

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 24, 2009

First Submission Date that Met QC Criteria

Aug 24, 2009

First Posted Date

Aug 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2010

Last Update Posted Date

Mar 9, 2010Estimated

Name	Class
TrygFonden, Denmark	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is aimed at increasing the safety of the use of anaesthesia in an elderly population (> 60 years). Patients with decreased physiological reserve, including all elderly patients, have an increased risk of getting an erroneous induction bolus. This project will investigate how fast elderly patients (> 60 years) fall asleep during bolus induction of anaesthesia with two of the most used hypnotics, thiopental and propofol, evaluated with BIS-monitoring and clinical signs of anaesthetic depth. The hemodynamic response will also be evaluated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thiopental	Experimental	Thiopental for induction of anaesthesia.	Drug: Thiopental
Propofol	Active Comparator	Propofol for induction of anaesthesia.	Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thiopental	Drug	Thiopental given as a bolus dose of 2,5 mg/kg.	Thiopental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
"Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.		120 seconds

Secondary Outcomes

Measure	Description	Time Frame
Hemodynamical effect (bloodpressure/pulse) every 60 seconds.		120 seconds
"Onset-time" defined as the time from started induction bolus to: - Time to loss of grip.		120 seconds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective surgical patients above 60 years of age, with an indication of general anaesthesia during surgery.
Informed consent.
The patient must be legally competent.
The patient must be able to read and understand Danish.

Exclusion Criteria:

Known allergic reactions to thiopental, propofol, lidocaine or alfentanil
"Body Mass Index" (BMI) <18 and > 35.
NYHA-class > 2.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Rasmussen, MD, PHD	Rigshospitalet, Denmark	Principal Investigator
Martin K Soerensen, MD	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet		Copenhagen		2100	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D013874	Thiopental
D015742	Propofol

Ancestor Terms

ID	Term
D013858	Thiobarbiturates
D001463	Barbiturates
D011744	Pyrimidinones
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

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