To compare and identify which drug is better among dexmedetomidine and ketamine when given as intravenous drug infusion for patients undergoing ear drum surgery.

Comparison of dexmedetomidine versus ketamine intravenous infusion with local anaesthesia in patients posted for tympanoplasty procedure in a tertiary care hospital, Chengalpattu : A Randomized, Double-Blind, Clinical study. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067044

Enrollment

Registered

2024-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: H720- Central perforation of tympanic membrane

Interventions

Intervention1: Use of dexmedetomidine versus ketamine as intravenous infusion in patients undergoing tympanoplasty under local anaesthesia.: to compare the efficacy of dexmedetomidine versus ketamine

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
Compare the efficacy of drugs dexmedetomidine and ketamine when used for intravenous sedation along with local anaesthesia in patients posted for tympanoplasty.Timepoint: Compare the efficacy of drugs dexmedetomidine and ketamine when used for intravenous sedation along with local anaesthesia in patients posted for tympanoplasty, at baseline, followed by every 15 minutes till the end of surgery.	—

Secondary

Measure	Time frame
1)Assessing patients satisfaction & intraoperative pain. 2)Assessing surgeons satisfaction with the sedation technique & surgical conditions.Timepoint: 1)Assessing patients satisfaction & intraoperative pain perception 2 hours after the surgery. 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.	—

Measure

Time frame

1)Assessing patients satisfaction & intraoperative pain. 2)Assessing surgeons satisfaction with the sedation technique & surgical conditions.Timepoint: 1)Assessing patients satisfaction & intraoperative pain perception 2 hours after the surgery. 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.

—

Countries

India

Contacts

Public ContactDr B Rajesh

karpaga vinayaga institute of medical sciences and research centre

rajeshanaes15@gmail.com9789892444

Outcome results

None listed

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