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CTRI Number  CTRI/2024/10/075785 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of intranasal versus intravenous dexmedetomidine efficacy to control bleeding in endoscopic sinus surgery 
Scientific Title of Study   Comparison of intranasal versus intravenous dexmedetomidine efficacy in quality of surgical field visualization in functional endoscopic sinus surgery a prospective randomized controlled clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dasari Subha Priyanka 
Designation  Junior Resident  
Affiliation  All India institute of medical sciences, Raipur 
Address  A Block operation theatre, Department of anesthesia, AIIMS Raipur,tatibandh raipur Chhattisgarh 492099

Raipur
CHHATTISGARH
492099
India 
Phone  9100308942  
Fax    
Email  priyankadasari200@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Sinha  
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Raipur 
Address  A Block Operation Theatre, 4th Floor Department of Anaesthesia, AIIMS Raipur, Tatiband Raipur Chhattisgarh 492099
AIIMS Raipur, Tatiband Raipur Chhattisgarh 492099
Raipur
CHHATTISGARH
492099
India 
Phone  9818113061  
Fax    
Email  drmamta12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dasari Subha Priyanka 
Designation  Junior Resident  
Affiliation  All India institute of medical sciences, Raipur 
Address  A Block operation theatre, Department of anesthesia, AIIMS Raipur, tatibandh raipur Chhattisgarh 492099

Raipur
CHHATTISGARH
492099
India 
Phone  9100308942  
Fax    
Email  priyankadasari200@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical sciences , Raipur , 492 099 , chhatisgarh 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dasari Subha Priyanka  AIIMS RAIPUR  A Block operation theatre, Department of anesthesia, AIIMS RAIPUR,tatiband raipur Chhattisgarh 492099
Raipur
CHHATTISGARH 		 9100308942

priyankadasari200@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J329||Chronic sinusitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparison of intranasal versus intravenous dexmedetomidine efficacy in quality of surgical field visualization in functional endoscopic sinus surgery: a prospective, randomized controlled clinical study  In the pre-operative area, participants in Group IN will be administered intranasal undiluted dexmedetomidine at a dose of 1mcg/kg using nasal atomizer 10 min before induction while Group IV will receive intranasal normal saline 0.5 mL .Both groups will be shifted to the operating room and undergo standard monitoring. General anesthesia will be administered to all patients. After induction, intravenous dexmedetomidine infusion 1mcg/kg will be given to Group IV, diluted in 10ml of saline solution over a 10 minute duration. while Group IN will receive 10ml saline solution . Maintenance of anesthesia will be done with oxygen and propofol infusion at the rate of 50-150mcg/kg/min with additional fentanyl given if needed. Mean arterial blood pressure will be maintained around 60-70mmHg, and neuromuscular blockade will be maintained as well. Total duration of procedure is 2 hrs. 
Comparator Agent  intranasal vs intravenous dexmedetomidine  In the pre-operative area, participants in Group IN will be administered intranasal undiluted dexmedetomidine, while Group IV will receive intranasal normal saline. Both groups will be shifted to the operating room and undergo standard monitoring. General anesthesia will be administered to all patients. After induction, intravenous dexmedetomidine infusion will be given to Group IV, while Group IN will receive saline solution. Maintenance of anesthesia will be done with oxygen and propofol infusion, with additional fentanyl given if needed. Mean arterial blood pressure will be maintained within a certain range, and neuromuscular blockade will be maintained as well. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 18 to 65 years, BMI 18 to 35kg/m2,
American Society of Anaesthesiologists (ASA) physical status I, II.
 
 
ExclusionCriteria 
Details  Patients Refusal for consent, History of any specific drug allergy, BMI more than 35kg/m2, Patients with ischemic and congestive heart disease, arrhythmia, Patients with uncontrolled hypertension, diabetes mellitus, Chronic obstructive pulmonary disease, Hepatic and renal dysfunction,Patients with Juvenile nasopharyngeal angiofibroma, recurrent epistaxis,Patients with a history of nasal allergy or requiring revisional nasal surgery
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intranasal administration of dexmedetomidine leads to better quality of surgical field and hemodynamic parameters than intravenous administration of dexmedetomidine in functional endoscopic sinus surgery   total case time is 2hrs
patients vital parameters recorded at every 10 min interval till the end of surgery and also visibility of the operative field will be assessed by the surgeon according to the Fromme and Boezaart scale. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 4 
Date of First Enrollment (India)   06/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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  

Title -  “Comparison of intranasal versus intravenous dexmedetomidine efficacy in quality of surgical field visualization in functional endoscopic sinus surgery: a prospective, randomized controlled clinical study”                          

                                                                -  Dr. Dasari Subha Priyanka

 

OBJECTIVES:

Primary Objective:

1.To assess the quality of surgical field visualization in intravenous and intranasal administration of dexmedetomidine in functional endoscopic sinus surgery.

Secondary objectives:

1.To assess the effect on intraoperative hemodynamics.

2.To assess the effect on emergence time.

3.To study incidence of adverse effects like hypotension, bradycardia, shivering and postoperative nausea vomiting.


JUSTIFICATION:

Randomized trials directly comparing the efficacy of intranasal and intravenous dexmedetomidine in enhancing the quality of the surgical field and hemodynamic parameters during functional endoscopic sinus surgery are currently not available. Hence, this study has been designed.

 

METHODOLOGY:

1. Study design: A prospective Randomized control, double blind clinical study.

2. Study duration: The study would be conducted over a period of one and half years after obtaining approval.

3. Study setting: Operation room AIIMS Raipur.

4 .Study population: Patients scheduled for elective functional endoscopic sinus surgery under general anaesthesia.

5. Sample size -  Calculated sample size – 80

Case – 40 , Control – 40

6. Plan of work –

Two randomly divided groups – who will be undergoing elective functional endoscopic sinus surgery

Group IN – who will receive intranasal dexmedetomidine

Group IV – who will receive IV dexmedetomidine

Neither the person administering the medication nor the patients will be informed of their group assignment during the course of the study.

 

·       Data will be collected - Demographic parameters: Age, gender, ASA physical status, duration of surgery,

·      HR, BP(MAP), RR, SPO2.

 

Intraop Baseline BP, Spo2 ,HR will be measured following every 10 min this parameters will be recorded in both the groups .

The visibility of the operative field will be assessed by the surgeon according to the scale proposed by the Fromme and Boezaart in which the amount of bleed will be measured in scores .

 

All information will be collected in Excel sheet and analysed in  SPSS-21.

Expected outcome: Intranasal administration of dexmedetomidine leads to better quality of surgical field and hemodynamic parameters than intravenous administration of dexmedetomidine in functional endoscopic sinus surgery.

 

 

 
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