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A clinical trial to study the effect of two drugs, Dexmedetomidine and Fentanyl in patients requiring ear surgery

Phase 4
Completed
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
Inclusion Criteria

Patients willing to give informed and written consent Patients belonging to ASAphysical status I and II Patients posted for planned surgery.

Exclusion Criteria

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
NameTimeMethod
Ramsay sedation scoreevery half an hourly intraoperatively | Boezaart scale-throughout surgery | Hemodynamic parameters-throughout surgery
Boezaart scaleevery half an hourly intraoperatively | Boezaart scale-throughout surgery | Hemodynamic parameters-throughout surgery
Hemodynamic parametersevery half an hourly intraoperatively | Boezaart scale-throughout surgery | Hemodynamic parameters-throughout surgery
Secondary Outcome Measures
NameTimeMethod
VAS Scoreevery 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, India
Dr Suman Shekhar Tiwari
Principal investigator
9978621648
rinkushekhar@gmail.com

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