| CTRI Number |
CTRI/2025/07/091092 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Medications (Dexmedetomidine and Clonidine)Given as Mist to see Which One is Better Controls Heart rate and blood pressure during Laryngoscopy and Tracheal Intubation on patients undergoing General anaesthesia procedure |
|
Scientific Title of Study
|
Evaluating The Efficacy Of
Nebulised Dexmedetomidine Vs Clonidine to Attenuate Hemodynamic Response During Laryngoscopy and Tracheal Intubation Under General Anaesthesia-A Prospective Randomised double blinded 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 |
SYLVIA N |
| Designation |
Postgraduate |
| Affiliation |
Esic Medical college and hospital |
| Address |
B-21/135V ,76 ,Vaigai street ,Nedunchalai nagar, Salem ,Tamilnadu 636005 Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078 Chennai TAMIL NADU 636005 India |
| Phone |
7299130329 |
| Fax |
|
| Email |
sylvian2626@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nataraj M S |
| Designation |
Head of the department |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078
Chennai TAMIL NADU 600078 India |
| Phone |
9886571461 |
| Fax |
|
| Email |
natarajms23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sylvia |
| Designation |
Postgraduate |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078
Chennai TAMIL NADU 600078 India |
| Phone |
7299130329 |
| Fax |
|
| Email |
Sylvian2626@gmail.com |
|
|
Source of Monetary or Material Support
|
| Esic Medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Esic Medical college and hospital |
| Address |
Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078 |
| Type of Sponsor |
Government medical college |
|
|
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 SYLVIA N |
Esic Medical college and hospital |
Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078 Chennai TAMIL NADU |
7299130329
sylvian2626@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Esic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H663||Other chronic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulised clonidine |
Clonidine 2mcg/Kg diluted in 4ml of 0.9% normal saline for 10 mins |
| Intervention |
Nebulised Dexmedetomidine |
Dexmedetomidine 2mcg/Kg diluted in 4ml of 0.9% normal saline for 10 Mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient with written informed consent
Either gender
Undergoing general anaesthesia procedure
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient allergic to drugs
Emergency surgeries
BMI more than 35
Pregnancy
Patient on beta-blockers ARB ACE Inhibitors
Anticipated difficult airway
Intubation duration more than one minute |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the hemodynamic response of dexmedetomidine Vs clonidine nebulization during laryngoscopy and tracheal intubation under general anaesthesia |
1 min,3 minutes, 5 minutes, 8 minutes, 11 minutes, 15 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Evaluate the post operative sore throat
To assess the occurrence of bradycardia & hypotension |
Postoperative sore throat 2 hours after extubation
Bradycardia, hypotension during & after nebulisation |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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
|
|
Brief Summary
|
Patients will be randomly assigned to one of two groups (A and B) using computer-generated random numbers. Group A will receive nebulisation with dexmedetomidine 2 mcg/kg in 4 ml of 0.9% normal saline. Group B will receive nebulisation with clonidine 2 mcg/kg in 4 ml of 0.9% normal saline. A qualified anaesthesiologist with 1 year of experience, uninvolved in the study, will prepare the study drugs. Allocation will be concealed using a sequential numbering system with sealed opaque envelopes, which will be opened in the pre-operative room. After allocation, baseline systolic, diastolic, and mean blood pressure, heart rate, and peripheral oxygen saturation (SpO2) will be recorded in the pre-anaesthetic room. Monitoring will continue throughout the nebulisation procedure, and vital signs will be recorded. Nebulisation will be performed using a wall-attached oxygen drive source 20 minutes before induction until the chamber empties. Any side effects like bradycardia (defined as heart rate less than 25 % of the baseline or <50/min) and hypotension (defined as systolic blood pressure less than 25 % of the baseline or <90 mm Hg) will be recorded during and after the nebulisation.
Patients will be transferred to the operating room, where standard ASA monitors will be attached. Following preoxygenation with 100% oxygen, fentanyl 2 mcg/kg will be administered intravenously. Anaesthesia will be induced with propofol titrated to loss of verbal response. Atracurium 0.5 mg/kg will be used for muscle relaxation. Direct laryngoscopy and endotracheal intubation will be performed using an appropriately sized laryngoscope and endotracheal tube. Intubation will be performed by a qualified anaesthesiologist with one year of experience. Cormack-Lehmann (CL) grading of laryngoscopy and duration of intubation will be recorded. Controlled ventilation will then be established and titrated to maintain end-tidal carbon dioxide at 30-40 mmHg. Systolic, diastolic, and mean blood pressure, heart rate, and SpO2 will be recorded during intubation and at 1, 3, 5, 8, 11, and 15-minutes post-intubation. If blood pressure increases by more than 25% from baseline, or if heart rate increases by more than 25% from baseline, esmolol 0.5 mg/kg will be administered intravenously to attenuate the hemodynamic response. Depth of anaesthesia will be maintained with sevoflurane to a minimal alveolar concentration (MAC) of 1. Intraoperative analgesics, fluids, blood products and vasopressors will be administered at the discretion of the consultant anaesthesiologist. Thirty minutes before the end of surgery, ondansetron 0.1 mg/kg will be administered intravenously. All patients will be reversed with neostigmine 0.05 mg/kg and glycopyrrolate 0.02mg/kg and extubated after meeting extubation criteria.
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