| 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
|
|
|
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
|
|
|
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.
|