To compare and identify which drug is better among dexmedetomidine and ketamine when given as intravenous drug infusion for patients undergoing ear drum surgery.
Phase 3
Completed
- Conditions
- Health Condition 1: H720- Central perforation of tympanic membrane
- Registration Number
- CTRI/2024/05/067044
- Lead Sponsor
- Dr M Vivekanandh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1) Patients belonging to ASA grade ? or II.
2) Patients weighing between 40-80 kgs.
3) Patients whose Height is between 140- 180 cm
Exclusion Criteria
1) Emergency surgeries.
2) Pregnant or breast-feeding patients.
3) Patients with significant arrhythmia or high degree atrioventricular nodal block.
4) Patients with significant hepatic, endocrinal or renal dysfunction.
5) Patients with Psychiatric or emotional disorder.
6) Patients with BMI greater than 30 kg/m².
7) Patients allergic to study drugs or anaesthetic medications utilized in the protocol.
8) Patients who had difficulty in communication (due to language problem or
deafness).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the efficacy of drugs dexmedetomidine and <br/ ><br>ketamine when used for intravenous sedation along with local anaesthesia <br/ ><br>in patients posted for tympanoplasty.Timepoint: Compare the efficacy of drugs dexmedetomidine and <br/ ><br>ketamine when used for intravenous sedation along with local anaesthesia <br/ ><br>in patients posted for tympanoplasty, at baseline, followed by every 15 minutes till the end of surgery.
- Secondary Outcome Measures
Name Time Method 1)Assessing patients satisfaction & intraoperative pain. <br/ ><br>2)Assessing surgeons satisfaction with the sedation technique & surgical conditions.Timepoint: 1)Assessing patients satisfaction & intraoperative pain perception 2 hours after the surgery. <br/ ><br>2)Assessing surgeons satisfaction with the sedation technique & surgical conditions at at baseline, 30 minutes & 60 minutes into the surgery & at the end of the surgery.