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CTRI Number  CTRI/2025/10/096451 [Registered on: 24/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing the efficacy of intranasal, nebulized, and intravenous routes of dexmedetomidine for blunting hemodynamic response to laryngoscopy and tracheal intubation in elective intracranial surgeries - A prospective, randomized, single blind clinical study. 
Scientific Title of Study   Comparison of efficacy of intranasal nebulized and intravenous routes of dexmedetomidine for blunting hemodynamic response to laryngoscopy and tracheal intubation in elective intracranial surgeries. A prospective randomized single-blind 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 Ramya L 
Designation  Post Graduate - Junior Resident 
Affiliation  AIIMS, RAIPUR 
Address  Department of Anesthesiology, AIIMS Raipur Raipur, CHHATTISGARH, India Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  6380207096  
Fax    
Email  lramya1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Monica Malhotra 
Designation  Professor 
Affiliation  AIMS, RAIPUR 
Address  Department of Anesthesiology, AIIMS Raipur Raipur CHHATTISGARH India Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8518881714  
Fax    
Email  monicakhetrapal@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monica Malhotra 
Designation  Professor 
Affiliation  AIMS, RAIPUR 
Address  Department of Anesthesiology, AIIMS Raipur Raipur CHHATTISGARH India Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8518881714  
Fax    
Email  monicakhetrapal@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Tatibandh, GE Road, Raipur, Chhattisgarh, India 492099 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 
Ramya L  AIIMS , RAIPUR  Department of Anaesthesiology, Neurosurgery OT, Superspeciality OT Complex 4th Floor, B block Raipur CHATTISGARH
Raipur
CHHATTISGARH 
6380207096

lramya1998@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: D496||Neoplasm of unspecified behavior of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intranasal Dexmedetomidine  Intranasal dexmedetomidine at dose of 1mcg/kg using nasal atomizer given 30 mins before induction 
Intervention  Intravenous dexmedetomidine  Intravenous dexmedetomidine 1 mcg/kg given 30 mins before induction 
Intervention  Nebulized dexmedetomidine  Nebulized dexmedetomidine 1 mcg/kg given 30 mins before induction 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patients of either gender
2)Age 18 to 65 years
3)ASA class I and II
4)Patients with GCS 12 to 15 
 
ExclusionCriteria 
Details  1)Patient refusal
2)Patients with anticipated difficult airway
3)Patients with hypertension or respiratory disorders or hepatic dysfunction or renal dysfunction
4)Patients undergoing emergency surgery
5)Pregnant patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the hemodynamic response between the intranasal, nebulized, and intravenous dexmedetomidine as premedication for blunting laryngoscopy and tracheal intubation response.  Till 15 minutes after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the sedation score
To compare the adverse effects of dexmedetomidine administration via three routes 
Till 15 minutes after intubation 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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)   10/11/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [lramya1998@gmail.com].

  6. For how long will this data be available start date provided 30-07-2027 and end date provided 11-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Laryngoscopy and tracheal intubation are common procedures that often elicit significant hemodynamic responses, including hypertension, tachycardia, arrhythmias, and an increase in intracranial pressure. This observation is supported by the finding that hemodynamic responses to tracheal intubation are associated with an increase in plasma catecholamine concentrations. Although the mechanisms underlying these responses are not completely understood, they have been attributed to a reflex sympathetic discharge caused by stimulation of the upper respiratory tract, mainly the supraglottic region, by the laryngoscope blade, along with the tracheal tube placement and cuff inflation.These effects must be reduced as much as possible, especially in high-risk patients, such as those with coronary artery disease, asthma, elevated intracranial pressure, or a cerebral aneurysm. To avoid such changes in intracranial pressure and hemodynamic parameters, various drugs are used for the attenuation of the laryngoscopic response; one such drug is Dexmedetomidine. It has also been found to be effective in attenuating the increase in ICP associated with laparoscopic surgeries. Dexmedetomidine, a highly selective alpha-2 receptor agonist, has sedative, amnestic, and analgesic-sparing effects without causing respiratory depression. It also possesses a sympatholytic effect, which can reduce the stress response to laryngoscopy and intubation. Intravenous administration is the most common and extensively studied route for Dexmedetomidine. However, intravenous administration may cause bradycardia and hypotension. Therefore, it is essential to investigate alternative routes of administration. Nebulized dexmedetomidine may be an alternative to intravenous administration because drug deposition following nebulization occurs over the nasal, buccal, as well as respiratory mucosa, resulting in better systemic absorption. Dexmedetomidine is rather rapidly and efficiently absorbed after intranasal administration; therefore, it has been used as a premedication for intravenous deep sedation in pediatric dental treatment. Intranasal administration is more convenient because it is innocuous, odorless, and requires no intravenous infusion. Furthermore, intranasal administration of a substance allows it to cross the blood-brain barrier and reach the central nervous system directly. Because of the increased vascularity of the nasal mucosa, medications can gain rapid access to the venous blood of the systemic circulation, thereby bypassing first-pass metabolism in the liver. Randomized controlled trials comparing the efficacy and side effects of all three administration routes—intranasal, nebulized, and intravenous dexmedetomidine—in attenuating the hemodynamic response to laryngoscopy and tracheal intubation specifically during elective intracranial surgeries are currently unavailable. This study was therefore designed to address this critical gap, aiming to optimize anesthetic techniques, improve perioperative outcomes, and enhance patient safety during airway manipulation in neurosurgical contexts.


 
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