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The use of the Compass-31 score for diagnosing the severity of nervous system dysfunction which controls the heartbeat and blood pressure and fluctuations in blood pressure and heart rate during surgery and the well-being after surgery in patients who have type 2 diabetes mellitus.

The utility of the Compass-31 questionnaire to predict the severity of autonomic dysfunction, thereby the intraoperative haemodynamic fluctuations and postoperative outcome in patients with type 2 diabetes mellitus undergoing surgery - A prospective observational cohort study. - UC31Q

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061971
Enrollment
110
Registered
2024-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Control Intervention1: nil: nil

Sponsors

DR RIYA LAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 or above with Type -2 diabetes mellitus undergoing surgery under anesthesia

Exclusion criteria

Exclusion criteria: 1.Patients with cardiac diseases such as valvular heart disease, arrhythmia, and congestive heart failure have low EF less than 40 percent. 2.Type 1 diabetes mellitus 3.Inherited autonomic dysfunction 4.History of recent stroke 5.Stage IV and V chronic Kidney Disease 6.Patients undergoing major surgery with an expected duration of less than 8 hours or rapid blood loss or major fluid shifts anticipated will be excluded

Design outcomes

Primary

MeasureTime frame
To assess the utility of the COMPASS 31 questionnaire as a screening tool for predicting the severity of autonomic dysfunction ,correlation between Compass-31 and Ewings battery of testing and intraoperative haemodynamic fluctuations in patients with type 2 diabetes mellitus undergoing surgery under anaesthesiaTimepoint: 24 hours

Secondary

MeasureTime frame
1.To assess the correlation between the severity of autonomic dysfunctions with the duration of the disease. 2.To assess the correlation between the severity of autonomic dysfunction and the levels of glycaemic control. 3.Correlation between the autonomic dysfunction and the incidence of perioperative renal dysfunction , rise in serum creatinine more than 0.3 mg per dl or 1.5 times above the baseline at 24 hrs cardiac dysfunction ,elevation of cardiac Troponin more than 2 SD at 12 to 24 hours after surgery. 4.Duration of hospital stay. 5.28 days mortality after surgery. Timepoint: 28 days

Countries

India

Contacts

Public ContactDr RIYA LAL

CHRISTIAN MEDICAL COLLEGE, VELLORE

ramamani@cmcvellore.ac.in9443753184

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026