Pharmacokinetic Study of Effect of Cardiac Output on the Uptake of Isoflurane

Anesthesia Clinical Trial

Official title:

Effect of Cardiac Output on Uptake of Isoflurane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351557
• Other study ID #: 9151/PG-2Trg/2012
• Status: Completed
• Phase: N/A
• First received: January 16, 2015
• Last updated: February 1, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study examines the effect of blood flow through the lungs and the body on the consumption and hence requirement of the anesthetic agent isoflurane.

Description:

The effect of cardiac output on the uptake of isoflurane is yet to be quantified. This study aims to obtain a quantifiable relationship between isoflurane uptake and cardiac output. The study patients will be cardiac patients in whom anesthesia is induced with fentanyl , propofol and maintained on isoflurane . The baseline cardiac index from the pulmonary artery catheter as displayed on the continuous cardiac output monitor will be used to classify the patients into two groups with cardiac index of 2.1 liters per minute per square meter as the differentiating criteria. No change in the anesthesia protocol will be done for the two groups.The study is designed such that all vascular catheterisations and the dose of isoflurane administered is as per prevailing institutional protocols and that no other intervention particular or unique to the study is done. As such the data that the study will use is also routinely acquired during the procedure but not systematically stored, which is what the study will do. This, we suggest, makes the study an observational study.The continuous cardiac output data and the inspired and expired concentration of isoflurane as displayed on the monitor will be recorded online. Data will be collected from the start of isoflurane till 30 minutes or till the surgeon starts cannulating the great vessels. The data so obtained will be analysed in two groups based on the baseline cardiac index using Statistical Package for the Social Sciences (SPSS) for difference in uptake between the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Presence of valve stenosis / valvular regurgitant lesion/ coronary artery disease with Ejection fraction >40%

• Posted for open cardiac surgery under general endotracheal anesthesia

Exclusion Criteria:

• Shunt lesion

• Allergy to propofol

• Psychotropic drug use

• Preinduction hemodynamic instability

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (3)

Kennedy RR, Baker AB. The effect of cardiac output changes on end-expired volatile anaesthetic concentrations--a theoretical study. Anaesthesia. 2001 Nov;56(11):1034-40. — View Citation

Myles PS, Storer R, Millar C. Haemodynamic effects and uptake of enflurane in patients undergoing cardiac surgery: good versus poor myocardial function. Anaesth Intensive Care. 1992 Feb;20(1):21-7. — View Citation

Watt SJ, Cook LB, Ohri S, Lockwood GG. The relationship between anaesthetic uptake and cardiac output. Anaesthesia. 1996 Jan;51(1):24-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of isoflurane in milliliter of vapor per minute		Every minute from 1 to 30 minutes	No