| CTRI Number |
CTRI/2025/07/092104 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
"Effect of a nasal sedative named dexmedetomidine on eye nerve pressure in adults undergoing throat surgery with a viewing scope"
|
|
Scientific Title of Study
|
Effect of intranasal Dexmedetomidine on optic nerve sheath diameter (ONSD) during suspension laryngoscopy in adult patients undergoing airway surgery: A randomised, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit kumar |
| Designation |
Junior Resident |
| Affiliation |
All india Institute of medical science,Ansari nagar East, New Delhi, 110029 |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room no:5011,5th floor, Academic block
All india Institute of medical science,Ansari nagar East, New Delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
9304524807 |
| Fax |
|
| Email |
rohitjnv14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room no:5011,5th floor, Academic block
All india Institute of medical science,Ansari nagar East, New Delhi, 110029
South
DELHI
110029
India |
| Phone |
8055087505 |
| Fax |
|
| Email |
amit2007kr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room no:5011,5th floor, Academic block
All india Institute of medical science,Ansari nagar East, New Delhi, 110029
South
DELHI
110029
India |
| Phone |
8055087505 |
| Fax |
|
| Email |
amit2007kr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
AIIMS, New Delhi, Ansari Nagar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rohit kumar |
All india Institute of medical science,Ansari nagar East, New Delhi, 110029 |
Room no:4,Porta cabin, Teaching block,Department of Anaesthesiology,Pain Medicine and critical care
New Delhi
DELHI |
09304524807
rohitjnv14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J387||Other diseases of larynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal dexmedetomidine |
Intranasal dexmedetomidine at 1mcg/kg using atomizer 30 min before shifting to Operating room |
| Comparator Agent |
Placebo |
Intranasal normal saline using atomiser 30 min before shifting to operating room |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18–60 years
ASA physical status I ,II and III
Scheduled for elective suspension laryngoscopy for airway surgery under GA
Patient giving written informed consent
|
|
| ExclusionCriteria |
| Details |
Eye diseases (Diabetic Retinopathy, Glaucoma, Retinal Detachment etc.)
History of elevated ICP (pseudotumor cerebri, hydrocephalus, Ventriculo-peritoneal shunt)
Known allergy to Dexmedetomidine
Severe cardiovascular or neurological disease
Pregnancy
Patient taking a methyldopa / clonidine/ other alpha 2 agonist
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Optic nerve sheath diameter (measured via ultrasound) |
T0- Pre-operative
T1- Pre-intubation (Post induction of anaesthesia)
T2- Just before removal of suspension laryngoscope
T3- pre-extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PRESSOR RESPONSE |
Before induction (Baseline)
Every minute post induction till suspension laryngoscopy removal
|
| Cough response |
at extubation |
| Level of sedation |
Pre induction
Post extubation 30 min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2025 |
| 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
|
This randomized, placebo-controlled trial aims to evaluate the effect of intranasal Dexmedetomidine on optic nerve sheath diameter (ONSD)—an indirect marker of intracranial pressure—during suspension laryngoscopy in adult patients undergoing elective airway surgery under general anesthesia.
Participants: 60 adults aged 18–60 years, classified as ASA I–III, scheduled for elective airway surgery, and who have provided informed consent. Exclusions include eye diseases, history of raised intracranial pressure, certain medications, severe systemic disease, pregnancy, and known allergy to Dexmedetomidine.
Design: Participants will be randomly assigned to receive either intranasal Dexmedetomidine (1 mcg/kg) or normal saline spray 30 minutes before surgery. The trial is triple-blind—neither the patients, investigators, nor data analysts will know group assignments.
Outcomes:
Primary Outcome: Optic nerve sheath diameter (ONSD) at four key time points using ultrasound.
Secondary Outcomes: Blood pressure responses, sedation level, and cough response during extubation.
Analysis: Statistical methods include t-tests, chi-square tests, and repeated measures ANOVA, with significance set at p<0.05.
Ethics & Timeline: Ethical clearance and clinical trial registration will be obtained. The study will run over 18 months, with 12 months for recruitment and 6 months for follow-up and data analysis.
Expected Impact: The study will help determine whether intranasal Dexmedetomidine effectively controls increases in intracranial pressure and cardiovascular responses during airway surgery, potentially improving anesthetic safety and patient comfort. |