A clinical trial to study the effect of two drugs, Dexmedetomidine and Fentanyl in patients requiring ear surgery
- Conditions
- Patients undergoing tympanoplasty surgery
- Registration Number
- CTRI/2018/01/011126
- Lead Sponsor
- Dhiraj general hospital
- Brief Summary
This study is a randomised, double blind, parallel group trial comparing the safety and efficacy of Dexmedetomidine 1 microgram/kg over 10 minutes i.v infusion as loading dose and maintenance dose as 0.5 microgram/kg/hour and Fentanyl 1 microgram/kg i.v as loading dose and maintenance dose as 0.5 microgram/kg/hour in ASAPS I and II patients undergoing elective tympanoplsty surgery that was conducted in single centre in india. Primary outcome measures were Ramsay sedation score, VAS score, Boezaart score and hemodynamic parameters.The purpose of this study is to compare fentanyl ; most commonly used opioid based analgesic with dexmedetomidine which is a novel drug commonly used for Monitered anaesthesia care now a days.In our study Ramsay sedation scale remained significantly higher in fentanyl group compared to dexmedetomidine group,the scale remained between 2-4 in all the patients during surgery which was adequate for the procedure to be performed.Analgesic effect of dexmedetomidine and fentanyl were comparable till 90 minutes in our study but after that analgesia provided by dexmedetomidine was better compared to fentanyl. Similar effects were found by the previous study, which was explained by the opioid sparing analgesic effect of dexmedetomidine. Although MAP remained stable in both groups, significant fall in heart rate was seen after 60 min in dexmedetomidine receiving patients compared to fentanyl receiving patients which can be explained by alpha 2 agonistic effect of dexmedetomidine. No clinically significant change in hemodynamic parameters were recorded during the study. Surgeon’s satisfaction in terms of Boezaart’s score was better in dexmedetomidine group compared to fentanyl group. Previous studies also found better surgical field with dexmedetomidine and they attributed this to hypotensive effect and quality of analgesia provided by dexmedetomidine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Patients willing to give informed and written consent Patients belonging to ASAphysical status I and II Patients posted for planned surgery.
Patients with severely compromising respiratory/cardiac/renal and hepatic dysfunction Morbidly Obese patients Pregnant and lactating women Patient with anticipated difficult airway.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ramsay sedation score every half an hourly intraoperatively | Boezaart scale-throughout surgery | Hemodynamic parameters-throughout surgery Boezaart scale every half an hourly intraoperatively | Boezaart scale-throughout surgery | Hemodynamic parameters-throughout surgery Hemodynamic parameters every half an hourly intraoperatively | Boezaart scale-throughout surgery | Hemodynamic parameters-throughout surgery
- Secondary Outcome Measures
Name Time Method VAS Score every half an hourly postoperatively till VAS score is more than 4
Trial Locations
- Locations (1)
Dhiraj general hospital
🇮🇳Vadodara, GUJARAT, India
Dhiraj general hospital🇮🇳Vadodara, GUJARAT, IndiaDr Suman Shekhar TiwariPrincipal investigator9978621648rinkushekhar@gmail.com