A study conducted in a tertiary care hospital comparing the sedative effects of Dexmedetomidine and Propofol infusion during middle ear operations.

Comparison on sedative effect of Dexmedetomidine and Propofol infusion in patients undergoing middle ear surgeries in a tertiary care hospital. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055887

Enrollment

Registered

2023-07-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: H758- Other specified disorders of middle ear and mastoid in diseases classified elsewhere

Interventions

Intervention1: Dexmedetomidine infusion: Dexmedetomidine infusion is given at a loading dose of 1 mcg/ kg IV over 10 mins followed by a maintenance dose of 0.4 mcg/ kg/ hr via iv route. Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age: 18 -60 years. 2.Sex: both male and female. 3.ASA grade I and II. 4.Patients undergoing middle ear surgeries in a tertiary care hospital.

Exclusion criteria

Exclusion criteria: 1.Pregnant or Lactating females. 2.Known drug allergies. 3. Active upper respiratory infection. 4.Psychological Disorders. 5. Patients with respiratory dysfunction/ Patients with OSA. 6.Obese patients.

Design outcomes

Primary

Measure	Time frame
To determine whether Dexmedetomidine or Propofol is more effective in providing sedation for middle ear surgeries. Adequate sedation would be defined as Ramsay Sedation Score 4- asleep but with brisk response to light glabelar tap or loud auditory stimulus.Timepoint: Comparing the time required to achieve adequate sedation for middle ear surgeries in two groups of participants at baseline 0mins, 10mins & 20mins.	—

Measure

Time frame

To determine whether Dexmedetomidine or Propofol is more effective in providing sedation for middle ear surgeries. Adequate sedation would be defined as Ramsay Sedation Score 4- asleep but with brisk response to light glabelar tap or loud auditory stimulus.Timepoint: Comparing the time required to achieve adequate sedation for middle ear surgeries in two groups of participants at baseline 0mins, 10mins & 20mins.

—

Secondary

Measure	Time frame
To compare the side effects of Dexmedetomidine & Propofol in terms of their impact on haemodynamic stability,respiratory function and pain management.Timepoint: Heart rate (HR), mean arterial pressure (MAP), respiratory rate (RR), oxygen saturation (SpO2), and expired CO2 (Et CO2) were recorded every 10 mins throughout the surgery & in the immediate postoperative period (at 10 and 20 min).	—

Countries

India

Contacts

Public ContactDr Rupankar Nath

Silchar Medical College and Hospital

rupankarnath05@gmail.com9401294057

Outcome results

None listed

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