| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
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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
- 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).
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lramya1998@gmail.com].
- 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.
- 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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