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Comparison of effects of Dexmedetomidine and Midazolam in fragmented sleep related glucose changes in post operative ICU patients.

Comparison of effects of Dexmedetomidine and Midazolam in attenuating fragmented sleep related glycemic variability in post operative intensive care patients - a single blinded placebo controlled prospective randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039570
Enrollment
180
Registered
2022-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intervention is 8 hourly monitoring of CBG for all patients participating in the study.: Study patients will be randomly allocated into 3 groups: Group M and Group P and Group D using c

Sponsors

Calcutta national medical college hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient and their relatives who consented for the study 2. Adults of the age 18-55 years of age 3. Patients who got admitted in SICU, MICU following post-operative emergency surgeries. 4. Patient who received Non-invasive ventilation in form of Cpap and BiPap with better prognosis. 5. Patients who were studied within 72 hours of surgery performed.

Exclusion criteria

Exclusion criteria: 1. Patients refused to give consent 2. Known prior diabetic history, or under Oral hypoglycemics or Insulin during or before hospital stay. 3. Paediatric patients ( 4. Patients with allergy to study drugs 5. Liver dysfunction or confirmed renal impairment (CKD, DCLD) 6. Patients who had known neurological (Epilepsy, Guillian Barre syndrome etc) or endocrinological (cushings disease, addisons disease etc.) disorders prior to the study. 7. Patients who were diagnosed with sepsis according to the recent SIRS guidelines. 8. Pregnant patients and lactating mothers 9. Patients who were on opioids like tramadol, fentanyl infusion during the study period. 10. Known prior cardiac illness like A-V block, previous MI, pacemaker implantation. 11. Patient who are ventilated and have poor prognosis. 12. Patients who are on additional muscle relaxant infusion 13. Patients who require vasopressor like Noradrenaline or dopamine infusions to maintain Mean arterial pressure above 65 mm Hg 14. Patients admitted for severe burns or road traffic accidents 15. Patients with BMI >30 and severely obese patients

Design outcomes

Primary

MeasureTime frame
Glucose levels of 180 mg/dl will be considered abnormal. Incidence of hyperglycemia (will be considered as primary outcome variable. The secondary outcome variables include severity of adverse events like nausea vomiting, degree of sedation, hemodynamic variables and average duration of hospital stay.Timepoint: 8 hourly monitoring for a period of 10 days

Secondary

MeasureTime frame
The secondary outcome variables include severity of adverse events like nausea vomiting, degree of sedation, hemodynamic variables and average duration of hospital stay.Timepoint: Monitored continuously over a period of 10 days

Countries

India

Contacts

Public ContactArun Muthukumar M K

Calcutta national medical college

arunmuthukumar27@gmail.com9445544089

Outcome results

None listed

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