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Comparison of a newer sedative drug (Dexmedetomidine)with other sedative agents (Midazolam and Fentanyl)for Retina surgery

A comparative evaluation of 2 different loading doses of Dexmedetomidine and Midazolam - Fentanyl combination for sedation in Vitreo Retinal surgery under peribulbar block

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/11/005181
Enrollment
60
Registered
2014-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa Health Condition 2: null- patients coming for Vitreo Retinal surgery

Interventions

Intervention1: Dexmedetomidine: Group B: 0.5micrograms/Kg IV loading dose over 10mins Group C: 0.25micrograms/Kg IV loading dose over 10mins on infusion pump Both groups are on titrated maintenance d

Sponsors

Nethradham Super Speciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA Grade I â?? III Vitrectomy under Local anaesthesia and intravenous sedation

Exclusion criteria

Exclusion criteria: Baseline heart rate less than 60 / min Age more than 70 years Severe left ventricular dysfunction (EF Hypovolemia with systolic blood pressure less than 90mmhg Mobitz type 2 and 3rd degree heart block Severe cardiac disease (valve stenosis/regurgitation). Chronic renal failure and hepatic impairment.

Design outcomes

Primary

MeasureTime frame
Level of sedation - Ramsay Sedation Scale was higher with 0.5 micrograms/kg loading dose of Dexmedetomidine.Timepoint: every 5 minutes

Secondary

MeasureTime frame
Bradycardia and hypotension noted with higher dose of DexmedetomidineTimepoint: every 5 minutes

Countries

India

Contacts

Public ContactDr Suman Shree Ramaswamy

Nethradhama Super Speciality Eye Hospital

ceo@nethradhama.org9845043831

Outcome results

None listed

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