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CTRI Number  CTRI/2026/01/100398 [Registered on: 06/01/2026] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   “Effect of Dexmedetomidine which is a group of drug commonly used in anesthesia practice,before the surgery through nebulisation route of administration in addition to standard treatment on visibility of surgical field and haemodynamic stability during the surgery  
Scientific Title of Study   “Effect of preoperative dexmedetomidine nebulisation as an adjunct to adrenaline nasal packing on surgical field quality and haemodynamic stability during transsphenoidal resection of pituitary adenoma: A prospective randomised double-blinded 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  Dr Muhammed Thoufeeq T  
Designation  Junior Resident  
Affiliation  AIIMS RAIPUR  
Address  room number 401 superspeciality OT complex Department of Anesthesia AIIMS Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  8592014453  
Fax    
Email  thoufeeqt1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Muhammed Thoufeeq T  
Designation  Junior Resident  
Affiliation  AIIMS RAIPUR  
Address  Room number 401 superspeciality OT complex Department of Anesthesia AIIMS Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  8592014453  
Fax    
Email  thoufeeqt1999@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Muhammed Thoufeeq T  
Designation  Junior Resident  
Affiliation  AIIMS RAIPUR  
Address  Room number 401 Superspeciality OT complex Department of Anesthesia AIIMS Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  8592014453  
Fax    
Email  thoufeeqt1999@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur 492001 chhattisgarh India 
 
Primary Sponsor  
Name  AIIMS RAIPUR 
Address  IEC,Room number 1803,new admin building AIIMS Raipur 492001,Chhattisgarh India 
Type of Sponsor  Government medical college 
 
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 Monica malhotra  AIIMS RAIPUR   Room number 401,Department of Anesthesia Superspeciality OT complex
Raipur
CHHATTISGARH 
8518881714

monicakhetrapal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,AIIMS RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ASA Physical Status I&II 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nebulised dexmedetomidine as an premedication   Nebulised dexmedetomidine(1 microgram per kilogram of body weight) will be given as a premedication in addition to adrenaline nasal packing in patients undergoing transsphenoidal resection pituitary adenoma  
Comparator Agent  Normal saline nebulisation   Normal saline(5 ml) nebulisation will be given as a premedication inaddition to adrenaline nasal packing in patients undergoing transsphenoidal resection of pituitary adenoma  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age: 18 to 65 years
BMI up to 30 kg/m2
ASA Physical Status I, II.
Scheduled for elective transsphenoidal pituitary surgery
 
 
ExclusionCriteria 
Details  GCS less than 12 and elevated ICP
History of known dexmedetomidine allergy
Patients with significant cardiovascular and respiratory disease
Patients coming for emergency surgery, pregnant patients.
Individuals with Cushing syndrome and Acromegaly

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of nebulised dexmedetomidine on surgical field quality in patients undergoing transsphenoidal resection of pituitary adenoma using Formmer’s surgical field score (scored by a single operating neurosurgeon at defined time points).
 
To assess the efficacy of nebulised dexmedetomidine on surgical field quality in patients undergoing transsphenoidal resection of pituitary adenoma using Formmer’s surgical field score (scored by a single operating neurosurgeon at defined time points).At the end of the surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of nebulised dexmedetomidine on haemodynamic response in patients undergoing transsphenoidal resection of pituitary adenoma
 
baseline,post nebulisation,Anesthesia induction,Intubation,Pre endoscopic insertion,Endoscopic insertion,Pre Adrenaline pack,Adrenaline Pack,Mucosal resection,Sphenoid drilling,Extubation,1 hour post extubation 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 2 
Date of First Enrollment (India)   22/01/2026 
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 Yet Recruiting 
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   Randomised trials for the efficacy of inhalational dexmedetomidine on intraoperative haemodynamic and surgical field quality in patients undergoing transsphenoidal resection of pituitary adenoma are currently very limited. Hence this study has been designed.
Dexmedetomidine has been widely studied in many surgical settings with possible benefits in lowering anaesthetic requirements, improving perioperative haemodynamic stability, and improving postoperative outcomes. This study aims to shed light on its potential as an adjuvant agent in anaesthesia for the specific surgical population and the efficacy of the inhalational route of administration of dexmedetomidine. 
Nebulized dexmedetomidine is a well-tolerated alternative to intravenous administration, with promising results in attenuating the haemodynamic stress response during airway manipulation and improving patient comfort. However, there is a paucity of data regarding its impact on surgical field conditions and intraoperative haemodynamics in the context of neurosurgical procedures, especially endonasal transsphenoidal pituitary surgeries where minimal bleeding and stable conditions are critical.
This study is designed to evaluate whether the addition of nebulised dexmedetomidine to standard adrenaline nasal packing enhances surgical field visibility and provide better haemodynamic control, thus offering a potential safer and more effective anaesthetic strategy for this patient population.


 
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