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The relation between HbA1c level before surgery with complications during and after surgery in type 2 diabetic patients

Completed
Conditions
Diabetes mellitus,
Registration Number
CTRI/2020/12/030012
Lead Sponsor
Dhananj Shivganesh BR
Brief Summary

This study is a prospective observational pilot study conducted on type 2 diabetic patients to see the correlation of preoperative HbA1c level with intraoperative complications like hypo and hyperglycaemic episodes, hemodynamic derangements, and postoperative complications like hypo and hyperglycaemic episodes, kidney injury, ischemic cardiac changes, ketoacidosis, infections in immediate postoperative period. Secondary aim is to find the correlation of preoperative HbA1c level with number of days to discharge in type 2 diabetic patients. 

After informed consent, 60 patients (30 in each group) aged 18 years and above, with diabetes scheduled for surgery having preoperative fasting blood sugar within normal limits will be categorised into each of the two above mentioned groups for prospective study. Preoperative baseline vitals will be noted and will be monitored during intraoperative period for highest and lowest heartrate, non-invasive blood pressure, mean arterial pressure and blood sugar levels hourly to assess hemodynamic instabilities and hypoglycaemic episodes. In the postoperative period, daily maximum and minimum blood glucose, serum and urine ketone body, ECG, total leukocyte count, temperature, renal function tests, assessment for surgical site infection will be done to look for kidney injury, episodes of ketoacidosis, ischemic changes in the heart, impaired glucose control, infectious complications. The wound status to assess for surgical site infection in the immediate postoperative period will be scored using Southampton scoring system(on the day of discharge or maximum up to 7th day, considering day 1 as the day of surgery. In the setting of discharge of patient within 7 days, patient will be enquired for symptoms of surgical site infection via telephonic survey based on CDC guidelines). Management of the complications that occur, will follow standard practice and no interference will be made to the same. Data will be entered in Microsoft Excel as a master chart and will be calculated in both absolute numbers, percentage scale as required for further analysis.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
Inclusion Criteria

Age 18 to 60 years BMI more than 18.5kg/m2 Known case of type 2 Diabetes Mellitus HbA1c levels available in preoperative period within 7 days Fasting blood sugar within normal value once during the 7 days of preoperative period.

Exclusion Criteria

Patient not willing for consent Known case of hypertension Heart failure/history of myocardial infarction, Arrhythmias Pregnant women Known case of immunodeficient diseases Known case of renal failure History of thyroid disorders.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Intraoperative complications like Hypo and Hyperglycaemic episodes, Hemodynamic derangementsIntraoperative complications will be monitored during surgery. | Post operative complications will be monitored for 7 days postoperative period
Postoperative complications like Hypo and Hyperglycaemic episodes, Kidney injury, Ischemic cardiac changes, Ketoacidosis in type 2 Diabetic patients, Infections in the immediate postoperative periodIntraoperative complications will be monitored during surgery. | Post operative complications will be monitored for 7 days postoperative period
Secondary Outcome Measures
NameTimeMethod
Number of days of hospital stayon day of discharge

Trial Locations

Locations (1)

AIIMS - Raipur

🇮🇳

Raipur, CHHATTISGARH, India

AIIMS - Raipur
🇮🇳Raipur, CHHATTISGARH, India
Dhananj Shivganesh BR
Principal investigator
8156901603
brdsg1995@gmail.com

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