Comparison of the effect of Dexmedetomidine with or without Pregabalin as before surgery in tympanoplasty under Local Anaesthesia.

A Randomized Controlled Trial to compare the effect of Dexmedetomidine with or without Pregabalin as premedication for conscious sedation in tympanoplasty under Local Anaesthesia - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073720

Enrollment

Registered

2024-09-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

None listed

Interventions

Intervention1: Dexmedetomidine with Pregabalin: one year four months Control Intervention1: Dexmedetomidine without Pregabalin: one year four months

Eligibility

Inclusion criteria

Inclusion criteria: AMERICAN SOCIETY OF ANESTHESIOLOGISTS(ASA) PHYSICAL STATUS CLASS 1 AND 2

Exclusion criteria

Exclusion criteria: 1. Patient refusal for Surgery. 2. Patient having Liver disorders. 3. Patient having Kidney disorders. 4. Patient having Cardiac and respiratory disease. 5. Patient having Morbid obesity. 6. Patient having allergy to the study drug.

Design outcomes

Primary

Measure	Time frame
Intraoperative and postoperative sedation score (by Modified Ramsay sedation score) between the two groups.Timepoint: Intraoperative vitals will be monitored after every 5 mins from the time of giving dexmedetomidine drug till 30 mins and then every 15 mins till 1 hour and then after every 30mins till 6 hours.	—

Secondary

Measure	Time frame
1.Intraoperative and postoperative analgesia (by VAS score) 2.intraoperative and postoperative hemodynamic parameters (HR, SBP, DBP, MBP). 3.intraoperative and postoperative side effects (hypotension, bradycardia, respiratory distress, nausea and vomiting).Timepoint: Intraoperative and postoperative score and vitals will be monitored after every 5 mins from the time of giving dexmedetomidine drug till 30 mins and then every 15 mins till 1 hour and then after every 30mins till 6 hours.	—

Measure

Time frame

1.Intraoperative and postoperative analgesia (by VAS score) 2.intraoperative and postoperative hemodynamic parameters (HR, SBP, DBP, MBP). 3.intraoperative and postoperative side effects (hypotension, bradycardia, respiratory distress, nausea and vomiting).Timepoint: Intraoperative and postoperative score and vitals will be monitored after every 5 mins from the time of giving dexmedetomidine drug till 30 mins and then every 15 mins till 1 hour and then after every 30mins till 6 hours.

—

Countries

India

Contacts

Public ContactDr Jyoti Sharma

Maharaja agrasen medical college

dr.jyotiumesh@gmail.com8607672844

Outcome results