DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Onset Time of Thiopental Versus Propofol in the Elderly

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Induction of Anaesthesia; Age

Intervention: Thiopental (Drug); Propofol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Lars Rasmussen, MD, PHD, Principal Investigator, Affiliation: Rigshospitalet, Denmark
Martin K Soerensen, MD, Principal Investigator, Affiliation: Rigshospitalet, Denmark

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.

Clinical Details

Official title: Onset Time of Thiopental Versus Propofol in the Elderly

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

Primary outcome: "Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.

Secondary outcome:

Hemodynamical effect (bloodpressure/pulse) every 60 seconds.

"Onset-time" defined as the time from started induction bolus to: - Time to loss of grip.

"Onset-time" defined as the time from started induction bolus to: - Time to eye closure.

"Onset-time" defined as the time from started induction bolus to: - Time to ciliary reflex cessation.

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, Copenhagen 2100, Denmark

Department of Anesthesia, Juliane Marie Center, Copenhagen University Hospital Rigshospitalet, Copenhagen 2100, Denmark

Additional Information

Starting date: September 2009
Last updated: March 8, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017