Clinical trial NCT02351557: Pharmacokinetic Study of Effect of Cardiac Output on the Uptake of Isoflurane
Official title: Effect of Cardiac Output on Uptake of Isoflurane
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2015-01-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective, open cardiac procedures under general endotracheal anesthesia with cardiopulmonary bypass

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.

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

Primary outcomes:
measure: Uptake of isoflurane in milliliter of vapor per minute
timeFrame: Every minute from 1 to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: GOVERDHAN D PURI, MD,Ph.D
role: STUDY_DIRECTOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Rajarajan Ganesan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Aveek Jayant, M.D.,D.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Shyam Thingnam, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1177/0310057X9202000104.
citation: 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.