Onset Time of Thiopental Versus Propofol in the Elderly

Age Clinical Trial

Official title:

Onset Time of Thiopental Versus Propofol in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965107
• Other study ID #: 1A-AGE/ONSET
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2009
• Last updated: March 8, 2010
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: February 2010
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age
• Induction of Anaesthesia

Intervention

Drug:
• Thiopental
Thiopental given as a bolus dose of 2,5 mg/kg.
• Propofol
Propofol given as a bolus dose of 1 mg/kg.

Locations

Country	Name	City	State
Denmark	Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet	Copenhagen
Denmark	Department of Anesthesia, Juliane Marie Center, Copenhagen University Hospital Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.		120 seconds	Yes
Secondary	Hemodynamical effect (bloodpressure/pulse) every 60 seconds.		120 seconds	Yes
Secondary	"Onset-time" defined as the time from started induction bolus to: - Time to loss of grip.		120 seconds	Yes
Secondary	"Onset-time" defined as the time from started induction bolus to: - Time to eye closure.		120 seconds	Yes
Secondary	"Onset-time" defined as the time from started induction bolus to: - Time to ciliary reflex cessation.		120 seconds	Yes