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

BPS Govt Medical College for Women1 site in 1 country72 target enrollmentStarted: January 4, 2021Last updated: May 4, 2022

Trial Snapshot

Phase: Phase 4
Status: Completed
Sponsor
Enrollment: 72
Locations: 1
Primary Endpoint: To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on post-operative psychomotor functions after middle ear surgeries done under local anesthesia

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

The aim of this study is 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. Thus this study will help us to choose a better sedative drug for short duration surgeries, so as to provide better sedation and analgesia to patients along with the advantage of producing lesser impairment of their psychomotor functions.

Study Design

Study Type: Interventional
Allocation: Computer generated randomization
Masking: Participant and Investigator Blinded

Eligibility Criteria

Ages: 18.00 Year(s) to 60.00 Year(s) (—)
Sex: All

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on anesthesia recovery in post-operative period(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 post-operative pain and sedation(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)
To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on hemodynamic parameters in post-operative period(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)

Investigators

Sponsor

BPS Govt Medical College for Women

Sponsor Class

Government medical college

Study Sites (1)

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