| CTRI Number |
CTRI/2025/11/096768 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of different doses of drugs in nebulised route to reduce airway responses during general anaesthesia technique . |
|
Scientific Title of Study
|
Comparison of nebulised Fentanyl and different doses of nebulised Dexmedetomidine in attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation in patients undergoing nasal surgery : A randomised double blind 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 |
DR PRIYA N |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KMC-RI Hubli |
| Address |
Karnataka medical college and research institute, Department of Anaesthesiology, room no. 206, IP division, Vidyanagar,Hubli
Dharwad KARNATAKA 580021 India |
| Phone |
8277253693 |
| Fax |
|
| Email |
priyaraani264@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR DHARMESH A LADHAD |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KMC-RI Hubli |
| Address |
Karnataka institute of medical sciences and research institute . Department of Anaesthesiology, room no.206 , IPdivision, Vidyanagar,Hubli
Dharwad KARNATAKA 580021 India |
| Phone |
9482097491 |
| Fax |
|
| Email |
ladhaddharmesh@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
DR PRIYA N |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KMC-RI Hubli |
| Address |
Karnataka medical college and research institute . Department of Anesthesiology, room no.206 , IP division, Vidyanagar, Hubli
Dharwad KARNATAKA 580021 India |
| Phone |
8277253693 |
| Fax |
|
| Email |
priyaraani264@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka medical college and research institute . Department of Anesthesiology, room no.206 , IP division, Vidyanagar, Hubli
Pin code 580021
Dharwad district
Karnataka state
India |
|
|
Primary Sponsor
|
| Name |
Karnataka medical college and research institute Vidyanagar Hubli |
| Address |
Karnataka medical college and research institute . Department of Anesthesiology, room no.206 , IP division, Vidyanagar, Hubli |
| Type of Sponsor |
Government medical college |
|
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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 PRIYA N |
Karnataka medical college and research institute |
Karnataka medical college and research institute . Department of Anesthesiology, room no.206 , IP division, Vidyanagar, Hubli Dharwad KARNATAKA |
8277253693
priyaraani264@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka medical college and research institute |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J342||Deviated nasal septum, (2) ICD-10 Condition: 8||Other Procedures, (3) ICD-10 Condition: H040||Dacryoadenitis, (4) ICD-10 Condition: J324||Chronic pansinusitis, (5) ICD-10 Condition: J330||Polyp of nasal cavity, (6) ICD-10 Condition: J343||Hypertrophy of nasal turbinates, (7) ICD-10 Condition: J339||Nasal polyp, unspecified, (8) ICD-10 Condition: J320||Chronic maxillary sinusitis, (9) ICD-10 Condition: J324||Chronic pansinusitis, (10) ICD-10 Condition: J341||Cyst and mucocele of nose and nasal sinus, (11) ICD-10 Condition: J393||Upper respiratory tract hypersensitivity reaction, site unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of different doses of drugs in nebulised form . |
IN this study we compare different drug dosages i,e nebulised fentanyl 1 mcg/kg , nebulised dexmedetomidine 1mcg/kg and nebulised dexmedetomidine 1.5 mcg/kg in patients undergoing nasal surgeries to reduce the stress responses to laryngoscopy and endotracheal intubation . |
| Intervention |
Reducing stress response to laryngoscopy and endotracheal intubation |
To compare different doses of nebulized dexmedetomidine and nebulized fentanyl in attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation in patients undergoing nasal surgeries. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
AMERICAN SOCIETY OF ANAESTHESIOLOGISTS [ASA]physical status classification I and II
Patients undergoing elective nasal surgeries under general anaesthesia
Patients giving valid informed written consent |
|
| ExclusionCriteria |
| Details |
Patients with neurological disorders , uncontrolled hypertension, uncontrolled Type 2 Diabetes mellitus,Ischemic heart disease, Chronic obstructive pulmonary disease, Bronchial asthma, Bleeding disorders, Psychiatric illness and nasal trauma .
Patients with history of allergy to opiods and local anaesthetic agents and dexmedetomidine .
Pregnant , lactating mothers.
Morbidly obese patients BMI more than 40 kg / m² |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of nebulised dexmedetomidine 1 mcg/kg ,1.5 mcg/kg and fentanyl 1 mcg/kg in attenuating hemodynamic stress response to laryngoscopy and endotracheal intubation in terms of changes in systolic blood pressure (SBP),Diastolic blood pressure (DBP),mean blood pressure (MBP)and heart rate (HR) in patients undergoing elective nasal surgeries. |
Nebulisation will be given 10min before shifting to operation theatre. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess postoperative pain using Visual Analog Scale immediately after extubation i.e 0hrand 1hr,3hr,6hr,12hr post surgery and extubation |
0hr , 1hr, 3hr, 6hr, 12hr post surgery and extubation. |
| To assess postoperative Ramsay sedation score immediately after extubation i.e 0hr and 1hr, 3hr,6hr, 12hr post surgery and extubation. |
0hr, 1hr, 3hr, 6hr, 12hr post surgery and extubation. |
|
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Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/11/2025 |
| 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 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
|
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Brief Summary
|
A prospective, randomized controlled trial will be conducted on 90 patients of ASA I and II undergoing elective nasal surgeries under general anaesthesia, between age group of 18-65 years in KIMS Hubballi. Patients will be enrolled for the study and randomly allocated into 3 groups as per computer generated table.
GROUP A (n=30): Patients who will receive nebulisation dexmedetomidine 1 ug/kg 10min before induction
GROUP B (n=30):Patients who will receive nebulisation dexmedetomidine 1.5 ug/kg 10min before induction .
GROUP C (n=30):Patients who will receive nebulization fentanyl 1ug/kg 10min before induction .
Pre-operative data will be collected prospectively for all patients undergoing nasal surgeries requiring general anaesthesia in our institution. All patients who meet the inclusion criteria, will undergo pre-anaesthetic evaluation a day prior to surgery. Height and weight of the patient will be noted. Informed valid written consent will be taken from all patients. Patients will be kept nil by mouth for solid food for 8 hours and clear liquids for 2 hours before surgery. Patients will be shifted to preoperative room on the day of surgery . Prenebulisation monitors will be connected HR ,SBP,DBP,MAP will be recorded . Preoperative anxiety will be assesed using APAIS in all the 3 groups . Patients according to the the group allocated will recieve nebulisation. The nebulization solution will be prepared by anaesthsiology resident not involved in making observations and the observer anaesthesiologist will be blinded. 10 min after the nebulisation anxiety and sedation will be assesed using RSS. Patients will be wheeled into the operation theatre and monitors will be attached (electrocardiography, non-invasive blood pressure, Oxygen saturation and heart rate) and baseline values of HR, SBP, DBP, MAP and SPO2 will be recorded.18 G IV cannula will be secured in the non-dominant upper limb of patient and Ringer lactate infusion will be started and patient will be briefed about the procedures to be performed. Patients premedicated with inj. glycopyrrolate 0.004mg/kg inj. midazolam 0.05 mg/kg and inj. Fentanyl 2mcg/kg i.v. After 3 minutes of preoxygenation, anaesthesia will be induced with Inj. Propofol 2 mg/kg i.v. and vecuronium bromide 0.1mg/kg will be given intravenously. Endotracheal intubation will be carried out after 3 minutes, with appropriate sized cuffed endotracheal tube (ETT) using Macintosh laryngoscope. Anaesthesia will be maintained with oxygen and nitrous oxide (50:50), intermittent vecuronium and sevoflurane. Minute ventilation will be adjusted to maintain normocapnia (etCO2 between 35 and 40 mmHg). During procedure HR, SBP , DBP , MAP will be recorded at 1 , 5, 10 min post intubation . All patients will receive infilteration on the nasal mucosa with 2% Lignocaine with adrenaline by the operating surgeon 15 minutes post intubation as is usually administered by the surgeons for nasal surgeries to achieve reduced blood loss and also analgesia.
At the end of the surgery, the inhalational anaesthetics used for maintenance of anaesthesia will be stopped . The HR, SBP, DBP and MAP values will be recorded. The muscle relaxation will be reversed with injection neostigmine 0.05mg/kg IV and glycopyrrolate 0.01 mg/kg .
Occurrence of any adverse events will be recorded. Hypotension is defined as fall in SBP<80 mmHg and bradycardia is defined as fall in HR<50 beats per minute. Hemodynamic fluctuations will be managed accordingly. Ondansetron (4 mg IV) will be administered on complaint of nausea and vomiting.
All patients will be administered inj paracetomol 20mg/kg post operatively TID for maintaining adequate analgesia .Patients will be assesed for post operative pain using VAS ( Visual Analog Scale) and RSS at 0,1, 3 , 6 , 12 hrs after the surgery.Any adverse events will be recorded and treated accordingly. |