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

Not yet recruiting

• Conditions: Deviated nasal septum,

• Registration Number: CTRI/2025/03/082660
• Lead Sponsor: DR BHARGAVI C S

Brief Summary

Controlled hypotension is reducing baseline mean arterial pressure(MAP) by 30% or maintaining MAP at 60-70 mmHg. FESS is generally used for the treatment of nasal polyposis, recurrent acute rhinosinusitis, leakage of cerebrospinal fluid, fungal infections, foreign objects in nasal cavity, mucocele periorbital abscess, epistaxis and tumors.



Major complications have been reported for FESS under general anaesthesia resulting from impaired visibility due to excessive bleeding . Serious complications associated with this procedure during perioperative period like orbital cellulitis, optic nerve injuries, meningitis whose incidence increase with excessive bleeding during surgery. Excessive bleeding is the most common limitation during the procedure which hinders the visibility of operative field which can be reduced by controlled hypotension.



Controlled hypotension after induction of general anaesthesia is commonly used in FESS which can be achieved by various pharmacological agents like inhalational anaesthetics, beta-adrenoceptor blocker, opioids, alpha 2 adrenergic agonists and magnesium sulfate can be used for controlled hypotension during general anaesthesia



Dexmedetomidine is a potent a 2 agonist. It has as sedative, anaesthetic, analgesic sparing effects, sympatholytic as well as vasoconstrictive effects.Central nervous system activation of post synaptic receptors by dexmedetomidine leads to inhibition of sympathetic activity, which decreases blood pressure and heart rate.Dexmedetomidine augments hypotensive action and reduces intraoperative bleeding.



Remifentanil hydrochloride is a short acting µ-opioid receptor agonist with analgesic. Effect equal to fentanyl. Remifentanil has been demonstrated to achieve a bloodless operative field without need for additional potent hypotensive agentsThis effect is mediated by its ability to lower heart rate,cardiac output and blood pressure

There are limited studies comparing remifentanil and dexmedetomidine in use for controlled hypotension. In this study, we propose to compare the efficacy of remifentanil and dexmedetomidine for controlled hypotensive anaesthesia in FESS

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-25
• Last Update Posted: 2025-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.surgeon 6 point scale	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
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	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
0= no bleeding	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
1=slight bleeding with no suctioning of blood required	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
2=slight bleeding with occasional suctioning required,surgical field not threatened	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
3=slight bleeding with frequent suctioning required,threatens the surgical field after suction is removed	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
4=moderate bleeding with frequent suctioning required,threatens the surgical field directly after suction is removed	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
5=severe bleeding with constant suction is required and bleeding that appears faster than can be removed by suction with surgical field severely threatened	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 Outcome Measures

Name	Time	Method
The hemodynamic variability in patients upon starting infusion of these study agents	0seconds,5,10,15,20,25,30,45,60,75,90minutes

Trial Locations

Locations (1)

McGANN TEACHING DISTRICT HOSPITAL; 🇮🇳 Shimoga, KARNATAKA, India

McGANN TEACHING DISTRICT HOSPITAL

🇮🇳Shimoga, KARNATAKA, India

DR BHARGAVI C S

Principal investigator

07899288725

drbhargavics@gmail.com