A study to compare effects of two drugs dexmeditomidine and fentanyl on blood pressure, pulse and recovery from general anesthesia in patients undergoing Ear Nose or throat surgery.

Recruiting

• Conditions: ASA Class 1&2 patients scheduled for elective ENT surgeries.

• Registration Number: CTRI/2015/07/006053
• Lead Sponsor: Dr Rohit Kaushikbhai Patel

Brief Summary

This study is a randomized, double blind, parallel group, active control trial comparing dexmedetomidine with fantanyl as an anesthetic adjuvants in patients undergoing ENT surgery. The study will be conducted to compare the sympatholytic effects and intraoperative hemodynamics and recovery parameters of dexmedetomidine with fentanyl. Both group will receive study drug bolus infusion (Dexmed group 1microgram/kg, Fentanyl group 2microgram/kg)(over 10 minutes followed by maintenance dose (Dexmed group 0.6microgram/kg/hr, Fentanyl group 1microgram/kg/hr)infusion. Patient will be induced with injection propofol 2-3 mg/kg i.v and rocuronium 0.9 mg/kg I.v. Patient will be maintain on oxygen, nitrous oxide, vecuronium intermittently and propofol infusion(75microgram/kg/min). The hemodynamic parameters and recovery variables Will be recorded at specific time interval.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-31
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• A) ASA class 1&2 scheduled for elective surgeries.
• B) age between 18 & 60 years.
• C) no history of alcohol or drug abuse.
• D) not received any opioid analgesic or alpha 2 agonist 24 hours prior to surgery.

Exclusion Criteria

• A)history of allergy to alpha agonist or sulpha drug.
• B)pregnant, lactating mothers and morbidly obese patients.
• C)heart block.
• D)presence of clinically significant neurologic, cardiac,renal,hepatic,gastrointestinal endocrine disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Study and compare the effects of dexmedetomidine with fentanyl for	Heamodynamics parameters observed intraoperatively and recovery variables during extubation.
1) The sympatholytic effects & intraoperative hemodynamics.	Heamodynamics parameters observed intraoperatively and recovery variables during extubation.
2) Reduction in intraoperative propofol requirement.	Heamodynamics parameters observed intraoperatively and recovery variables during extubation.
3) The recovery variables.	Heamodynamics parameters observed intraoperatively and recovery variables during extubation.

Secondary Outcome Measures

Name	Time	Method
To compare analgesic sparing effects and postoperative nausea and vomiting of dexmedetomidine with fentanyl.	Secondary outcome observed after extubation for one hour.

Trial Locations

Locations (1)

New Civil Hospital Surat; 🇮🇳 Surat, GUJARAT, India

New Civil Hospital Surat

🇮🇳Surat, GUJARAT, India

Dr Rohit Kaushikbhai Patel

Principal investigator

7383672450

dr.rohitpatel2403@gmail.com