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Comparison of efficacy in terms of sedation, analgesia, discharge from post anesthesia care unit, of dexmedetomidine with the efficacy of combination of midazolam fentanyl for middle ear surgeries (MESs) under local anesthesia

Comparison of dexmedetomidine with combination of midazolam fentanyl for middle ear surgeries (MESs) under monitored anesthesia care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023155
Enrollment
80
Registered
2020-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: H72- Perforation of tympanic membrane Health Condition 2: H70- Mastoiditis and related conditions

Interventions

Intervention1: Dexmedetomidine: Administration of dexmedetomidine in loading dose of 1 microgram/kg and infusion dose of 0.3 - 0.7 microgram/kg/hr intravenous to patients undergoing middle ear surgeri

Sponsors

Department of anesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American society of anesthesiologists grade 1 and 2. Patients posted for middle ear surgeries.

Exclusion criteria

Exclusion criteria: Patients unwillingness/ refusal. Patients with known sensitivity to local anesthetic drug lignocaine. Patients with impaired mentation, significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease. Pregnant or lactating women Morbid obesity (BMI > 40 kg/m2). Patients on any analgesics or sedatives.

Design outcomes

Primary

MeasureTime frame
Sedation. Analgesia. Hemodynamic stability Discharge from Post Anesthesia care unit.Timepoint: Time to achieve Ramsay Sedation Score 3 Time of surgery 3 hrs Time of giving rescue sedative and analgesic. Time from discharge frommPACU—

Secondary

MeasureTime frame
To compare surgeon and patient satisfaction Any side effectsTimepoint: 7 point likert scale—

Countries

India

Contacts

Public ContactDr Priyanka

Bhagat phool singh government medical college

sarv.mlb007@gmail.com9728800122

Outcome results

None listed

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