| CTRI Number |
CTRI/2025/03/082660 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare two drugs dexmedetomidine and remifentanil in achieving controlled hypotension in functional endoscopic sinus surgery |
|
Scientific Title of Study
|
COMPARISON BETWEEN REMIFENTANIL AND DEXMEDETOMIDINE FOR CONTROLLED HYPOTENSIVE ANAESTHESIA IN FUNCTIONAL ENDOSCOPIC SINUS SURGERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BHARGAVI C S |
| Designation |
Postgraduate student |
| Affiliation |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of anaesthesiology , major OT complex,3rd floor,McGANN District teaching hospital , shimoga institute of medical sciences
Shimoga
KARNATAKA
577201
India |
| Phone |
07899288725 |
| Fax |
|
| Email |
drbhargavics@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KUMAR AB |
| Designation |
Associate professor |
| Affiliation |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology , major OT complex,3rd floor, McGann District teaching hospital , Shimoga institute of medical sciences
Shimoga
KARNATAKA
577201
India |
| Phone |
08861958933 |
| Fax |
|
| Email |
kumarab_bmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR KUMAR AB |
| Designation |
Associate professor |
| Affiliation |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology , major OT complex,3rd floor, McGann District teaching hospital , Shimoga institute of medical sciences
Shimoga
KARNATAKA
577201
India |
| Phone |
08861958933 |
| Fax |
|
| Email |
kumarab_bmc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| McGANN TEACHING DISTRICT HOSPITAL SHIVAMOGA KARNATAKA INDIA 577201 |
|
|
Primary Sponsor
|
| Name |
DR BHARGAVI C S |
| Address |
Department of anaesthesiology , major OT complex,3rd floor,McGANN District teaching hospital , shimoga institute of medical sciences karnataka india 577201 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR BHARGAVI C S |
McGANN TEACHING DISTRICT HOSPITAL |
Department of anaesthesiology , major OT complex,3rd floor,McGANN District teaching hospital , shimoga institute of medical sciences
Shimoga
KARNATAKA |
07899288725
drbhargavics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J342||Deviated nasal septum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DEXMEDETOMIDINE
|
GROUP D will receive bolus dose of 0.5mcg/kg followed by infusion of 02-0.2mcg/kg/hour
|
| Intervention |
REMIFENTANIL |
GROUP R will receive bolus dose of 1mcg/kg followed by infusion of 0.2-0.4mcg/kg/minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
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
|
| Outcome |
TimePoints |
| The hemodynamic variability in patients upon starting infusion of these study agents |
0seconds,5,10,15,20,25,30,45,60,75,90minutes |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 ยต-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 |