To compare two sedative drugs for providing comfort during ear drum surgery under local anaesthesia
Not Applicable
- Conditions
- Health Condition 1: H729- Unspecified perforation of tympanic membrane
- Registration Number
- CTRI/2021/03/031974
- Lead Sponsor
- Government Of Gujarat
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedative effect <br/ ><br>Analgesic effect <br/ ><br>Hemodynamic variables (HR, MAP) <br/ ><br>Respiratory variables (RR, SpO2) <br/ ><br>Patientâ??s and surgeonâ??s satisfaction (Likert score) <br/ ><br>Recovery profile (Aldrete score) <br/ ><br>Frequency of rescue analgesic requiredTimepoint: From measuring basal hemodynamic parameters pre operatively to 15 minutes in the post operative recovery room.
- Secondary Outcome Measures
Name Time Method Perioperative complicationsTimepoint: From intravenous injection of dexmedetomidine or fentanyl preoperatively to 15 mins post operative recovery room