| CTRI Number |
CTRI/2025/10/095513 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of nasal Dexmedetomidine spray on blood pressure and heart rate during endotracheal tube removal in gallbladder surgery in patients with high blood pressure |
|
Scientific Title of Study
|
Effect of intranasal Dexmedetomidine on hemodynamic responses during tracheal extubation in hypertensive patients undergoing laparoscopic cholecystectomy: A Randomized 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 |
Kartik Saini |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, Room no. 5011, 5th floor, Academic Block, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
9467817253 |
| Fax |
|
| Email |
ks.kartik98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudhansu Sekhar Nayak |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, Room no. 5011, 5th floor, Academic Block, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
8874756836 |
| Fax |
|
| Email |
nayak.sudhansusekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kartik Saini |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, Room no. 5011, 5th floor, Academic Block, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
9467817253 |
| Fax |
|
| Email |
ks.kartik98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences ,New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, Room no. 5011, 5th floor, Academic Block, All India Institute of Medical Sciences, Ansari Nagar East,New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesiology Pain Medicine and Critical Care |
All India Institute of Medical Sciences, Ansari Nagar East, New Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kartik Saini |
All India Institute of Medical Sciences, New Delhi |
Operation Theatre number 2,3,4,5,6,7,8,9,10,11,12, Surgical Block.
Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi 110029
South
DELHI |
9467817253
ks.kartik98@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
This group will receive intranasal(through nose) dexmedetomidine of total dose of 1 microgram per kg body weight(1 µg/kg) only once 30 minutes before extubation. Duration of this intervention will be few seconds but drug effect will remain up to 1 to 2 hours. Total calculated dose will be diluted to 2ml with normal saline and 1ml in each nostril will be sprayed by intranasal mucosal atomization device.
|
| Comparator Agent |
Normal Saline |
This group will receive intranasal normal saline 2 ml (1ml in each nostril will be sprayed by intranasal mucosal atomization device). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with controlled hypertension on anti hypertensive medications.
2. Patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
3. Patients falling under ASA- II,III category. |
|
| ExclusionCriteria |
| Details |
1. Patients allergic to dexmedetomidine.
2. Patients having severe cardiac conduction abnormalities.
3. Patients on chronic sedatives or opioid use.
4. Patients having nasal pathology preventing intranasal drug delivery
5. Patients with heart rate less than 60 beats per minute. |
|
|
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 |
| Changes in mean blood pressure from baseline at the time of extubation |
0, 1, 2, 3, 5, 10,15 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in heart rate(HR), systolic blood pressure(SBP) and diastolic blood pressure( DBP) from baseline at the time and after extubation |
0, 1, 2, 3, 5, 10,15 minutes after extubation |
| Sedation Score (Ramsay Sedation Score) |
15, 30, 60 minutes after extubation |
| Visual Analogue Scale (VAS) pain score |
15, 30, 60 minutes after extubation |
| Incidence of adverse events ( for example bradycardia, hypotension, nausea, vomiting, delayed emergence) |
2 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
|
Endotracheal extubation causes transient hemodynamic changes leading to increase in blood pressure and heart rate (HR) due to increase in sympathoadrenergic activity caused by epipharyngeal and laryngopharyngeal stimulation. Hypertensive patients undergoing surgical procedures like laparoscopic cholecystectomy are at amplified risk for adverse hemodynamic events during peri extubation period, making them ideal candidates for evaluating the efficacy of a sedative-sympatholytic agent like intranasal dexmedetomidine. While previous research has explored the intravenous use of dexmedetomidine to modulate extubation responses, literature on the intranasal route, particularly in hypertensive patients, remains sparse. This study is required to investigate the effectiveness of intranasal dexmedetomidine in attenuating hemodynamic responses during tracheal extubation in hypertensive patients undergoing laparoscopic cholecystectomy. By evaluating the efficacy and safety of intranasal dexmedetomidine, this study can inform clinical practice, optimize perioperative care, and potentially improve patient outcomes. The findings of this study can contribute to the development of evidence-based guidelines for managing hypertensive patients undergoing laparoscopic cholecystectomy, ultimately enhancing patient safety and reducing morbidity.
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