World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12616001395426
Date of registration: 07/10/2016
Prospective Registration: Yes
Primary sponsor: safdarjung hospital
Public title: The changes in serum potassium and blood sugar levels during heart surgery
Scientific title: Trend of changes in the intraoperative blood glucose and serum potassium levels of adult patients undergoing Off-Pump Coronary Artery Bypass surgeries
Date of first enrolment: 14/10/2016
Target sample size: 36
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12616001395426.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Non-randomised trial;  
Phase: 
Countries of recruitment
India
Contacts
Name: A/Prof kapil gupta   
Address:  Associate professor, department of anesthesia vardhaman mahavir medical college & safdarjung hospital, Ring Road,New delhi, Delhi, India- 110029 India
Telephone: +91-9811859019
Email: kapgup11@yahoo.co.in
Affiliation: 
Name: A/Prof kapil gupta   
Address:  Associate professor, department of anesthesia vardhaman mahavir medical college & safdarjung hospital, Ring Road,New delhi, Delhi, India- 110029 India
Telephone: +91-9811859019
Email: kapgup11@yahoo.co.in
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Patients of either sex, undergoing CABG
Exclusion criteria: Any liver/ renal abnormality

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Anaesthesiology - Other anaesthesiology
Cardiovascular - Coronary heart disease
heart surgery;
heart surgery
Intervention(s)
36 adult patients of either sex undergoing elective off pump coronary bypass surgery (OPCAB) in Safdarjung hospital, New Delhi, India will be enrolled in this study. In the operation theatre, Etomidate/ Morphine ( 0.1 mg/kg) / Fentanyl (2 ug/kg) / vecuronium bromide (0.1mg/kg)/Oxygen/ Air will be used to induce anesthesia. Anesthesia will be maintained using oxygen/ air/ isoflurane and topups of vecuronium and morphine. Arterial blood gas analysis will be done by the staff anesthesiologist at predetermined intra-operative time points to measure levels of blood glucose and serum potassium as primary variables. Base excess, pH and HCO3? will be recorded as secondary variables. The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min at 30 min ( T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft ( T6) and end of surgery (T7). Insulin infusion will be started according to the sliding scale, whenever blood glucose will be higher than 200 mg/dl. Potassium Chloride 5 ml will be supplemented whenever serum potassium will be lower than 4mEq/l.
Primary Outcome(s)
blood sugar levels will be measured intraoperatively at regular intervals[The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ---at 30 min ( T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7). ]
serum potassium levels will be measured intraoperatively at regular intervals[The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ---at 30 min ( T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7). ]
Secondary Outcome(s)
serum base excess levels will be measured intraoperatively[The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ----at 30 min (T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7). ]
serum HCO3 variation with time will be measured intraoperatively[The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ----at 30 min (T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7). ]
serum pH variation with time will be measured intraoperatively [The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ----at 30 min (T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7). ]
Secondary ID(s)
none
Source(s) of Monetary Support
safdarjung hospital
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
vardhaman mahavir medical college & safdarjung hospital ethics committee
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history