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To compare two sedative drugs for providing comfort during ear drum surgery under local anaesthesia

A study of dexmedetomidine versus fentanyl for monitored anaesthesia care during tympanoplasty in adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031974
Enrollment
120
Registered
2021-03-15
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: H729- Unspecified perforation of tympanic membrane

Interventions

Intervention1: Intravenous injection Dexmedetomidine or Fentanyl for monitored anesthesia care: Patient will receive intravenous loading dose of 1mcg/kg followed by 0.4mcg/kg/hr infusion of either de

Sponsors

Government Of Gujarat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Informed written consent for participation in study 2. Age: 18 - 40 years 3. Patients of either gender 4. ASA physical status I and II (ASA-American society of anaesthesiologist) 5. Elective tympanoplasty under local anaesthesia 6. Adequate fasting period-Nil by mouth 6 hours for solids and 4 hours for fluid

Exclusion criteria

Exclusion criteria: 1. Patient refusing consent 2. Anticipated difficult airway 3. BMI >25 4. Alcohol or drug addiction 5. Neuropsychiatric disease 6. History of drug allergy including allergy to local anaesthetic 7. Patient taking sedatives, analgesics or any other agent having a cardiac, respiratory and gastrointestinal effects 8. Antenatal and lactating females 9. Active upper respiratory tract infection /lower respiratory tract infection

Design outcomes

Primary

MeasureTime frame
Sedative effect Analgesic effect Hemodynamic variables (HR, MAP) Respiratory variables (RR, SpO2) Patientâ??s and surgeonâ??s satisfaction (Likert score) Recovery profile (Aldrete score) Frequency of rescue analgesic requiredTimepoint: From measuring basal hemodynamic parameters pre operatively to 15 minutes in the post operative recovery room.

Secondary

MeasureTime frame
Perioperative complicationsTimepoint: From intravenous injection of dexmedetomidine or fentanyl preoperatively to 15 mins post operative recovery room

Countries

India

Contacts

Public ContactDr Dipshikha Tripathi

B.J.MEDICAL.COLLEGE

drtripathi1961@yahoo.co.in9428408718

Outcome results

None listed

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