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Comparision of Dexmedetomidine versus Midazolam and Fentanyl combination on post-operative psychomotor functions and recovery

To compare the effect of dexmedetomidine versus midazolam and fentanyl combination on post-operative psychomotor functions and recovery in patients after middle ear surgeries done under local anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032061
Enrollment
72
Registered
2021-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: H65-H75- Diseases of middle ear and mastoid

Interventions

Intervention1: Dexmedetomidine: dexmedetomidine, a newly developed drug being used clinically for sedation in intensive care units has shown exciting prospects. It is an Ã?±ââ?¬â??2 agonist acting o

Sponsors

BPS Govt Medical College for Women
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are willing to give written informed consent to participate in the study. 2. Patients aged between 18 and 60 years undergoing middle ear surgery done under local anesthesia. 3. Patients fit for the procedure according to Pre Anesthetic Checkup. 4. Patients who are literate at least up to 5th standard or more. 5. Patient having physical status of 1 and 2 according to American Society of Anesthesiologists

Exclusion criteria

Exclusion criteria: 1. Patients who are not willing to give written informed consent. 2. Patients having a history of any neurological or psychological disease. 3. Patients who have a history of hypersensitivity to any of the study drugs or any contraindication to any drug involved in this study. 4. Patients who are taking any medicine that affects psychomotor functions.

Design outcomes

Primary

MeasureTime frame
To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on post-operative psychomotor functions after middle ear surgeries done under local anesthesiaTimepoint: Baseline psychomotor assessment and delirium assessment will be done 30 minutes prior to the shifting of patient to operation theatre and after completion of surgery both will be assessed at 1hour, 2 hour, 4 hour and 8 hour

Secondary

MeasureTime frame
To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on anesthesia recovery in post-operative periodTimepoint: Anesthesia recovery will be assessed at every 30 minutes starting from the time of shifting of patient to post anesthesia care unit till the time patient is discharged from Post anesthesia care unit.;To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on hemodynamic parameters in post-operative periodTimepoint: Hemodynamic parameters will be checked 30 minutes prior to surgery and at every 15 minutes for first 30 minutes during the surgery and then at every 30 minutes till the end of surgery. In post-operative period, parameters will be checked at every 30 minutes till the patient is discharged from PACU;To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on post-operative pain and sedationTimepoint: Pain of the patient will be assessed every 30 minutes starting from the time of shifting of patient to post anesthesia care unit till the time patient is discharged from PACU Intra operative Sedation level will be assessed every 10 minutes.Post operative sedation will be at 1 hour, 2 hour, 4 hour and 8 hours after completion of surgery

Countries

India

Contacts

Public ContactDr Abhinav Goyal

Bhagat Phool Singh Government Medical College

garimaahuja2010@yahoo.com9992108132

Outcome results

None listed

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