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

NCT ID: NCT02351557

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-12-31

Brief 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.

Detailed 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.

Conditions

Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Reference

Baseline cardiac index more than or equal to 2.1 liters per minute per square meter

No interventions assigned to this group

Low cardiac output

Baseline cardiac index less than 2.1 liters per minute per square meter

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Rajarajan Ganesan

Junior Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GOVERDHAN D PURI, MD,Ph.D

Role: STUDY_DIRECTOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Rajarajan Ganesan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Aveek Jayant, M.D.,D.M.

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Shyam Thingnam, M.S.

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Countries

India

References

Watt SJ, Cook LB, Ohri S, Lockwood GG. The relationship between anaesthetic uptake and cardiac output. Anaesthesia. 1996 Jan;51(1):24-8. doi: 10.1111/j.1365-2044.1996.tb07648.x.

Reference Type: BACKGROUND

PMID: 8669560 (View on PubMed)

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. doi: 10.1177/0310057X9202000104.

Reference Type: BACKGROUND

PMID: 1609936 (View on PubMed)

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. doi: 10.1046/j.1365-2044.2001.02212.x.

Reference Type: BACKGROUND

PMID: 11703234 (View on PubMed)

Other Identifiers

9151/PG-2Trg/2012

Identifier Type: -

Identifier Source: org_study_id