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A clinical trial to compare two drugs dexmedetomidine and remifentanil in achieving controlled hypotension in functional endoscopic sinus surgery

COMPARISON BETWEEN REMIFENTANIL AND DEXMEDETOMIDINE FOR CONTROLLED HYPOTENSIVE ANAESTHESIA IN FUNCTIONAL ENDOSCOPIC SINUS SURGERY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082660
Enrollment
64
Registered
2025-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: J342- Deviated nasal septum

Interventions

Intervention1: REMIFENTANIL: GROUP R will receive bolus dose of 1mcg/kg followed by infusion of 0.2-0.4mcg/kg/minute Control Intervention1: DEXMEDETOMIDINE : GROUP D will receive bolus dose of 0.5mcg

Sponsors

DR BHARGAVI C S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to participate in the study 2. Patients undergoing functional endoscopic sinus surgery 3.age group of 18-60 of either sex 4. American society of Anaethesiologist (ASA) physical status I and II

Exclusion criteria

Exclusion criteria: 1.History of allergy to any drugs 2.patients with cardiovascular disease, cerebrovascular insufficiency poorly controlled arterial hypertension,coagulation disorders 3.history of substance abuse

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of dexmedetomidine and remifentanil infusion in achieving controlled hypotension in Functional endoscopic sinus surgery (FESS) patients and obtaining bloodless operative field assessed by 1.surgeon 6 point scale 0= no bleeding 1=slight bleeding with no suctioning of blood required 2=slight bleeding with occasional suctioning required,surgical field not threatened 3=slight bleeding with frequent suctioning required,threatens the surgical field after suction is removed 4=moderate bleeding with frequent suctioning required,threatens the surgical field directly after suction is removed 5=severe bleeding with constant suction is required and bleeding that appears faster than can be removed by suction with surgical field severely threatenedTimepoint: To compare the efficacy of dexmedetomidine and remifentanil infusion in achieving controlled hypotension in Functional endoscopic sinus surgery (FESS) patients and obtaining bloodless operative field assessed by 1.surgeon 6 point scale 0= no bleeding 1=slight bleeding with no suctioning of blood required 2=slight bleeding with occasional suctioning required,surgical field not threatened 3=slight bleeding with frequent suctioning required,threatens the surgical field after suction is removed 4=moderate bleeding with frequent suctioning required,threatens the surgical field directly after suction is removed 5=severe bleeding with constant suction is required and bleeding that appears faster than can be removed by suction with surgical field severely threatened—

Secondary

MeasureTime frame
The hemodynamic variability in patients upon starting infusion of these study agentsTimepoint: 0seconds,5,10,15,20,25,30,45,60,75,90minutes—

Countries

India

Contacts

Public ContactDR KUMAR AB

SHIMOGA INSTITUTE OF MEDICAL SCIENCES

kumarab_bmc@yahoo.co.in08861958933

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026