| CTRI Number |
CTRI/2021/04/032855 [Registered on: 15/04/2021] Trial Registered Prospectively |
| Last Modified On: |
14/04/2021 |
| 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
|
The effect of drug dexmedetomidine nebulization on circulatory parameters due to laryngoscopy and intubation in patients during general anaesthesia |
|
Scientific Title of Study
|
The effect of preoperative dexmedetomidine nebulization on the haemodynamic response to laryngoscopy and intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apurva Rathour |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care , Block D Level 5, Government Medical College and Hospital , Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
6284916781 |
| Fax |
|
| Email |
apurva.rt9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakesh K Anand |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital , Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, GMCH Chandigarh
Block D , Level 5
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakesh K Anand |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital , Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, GMCH Chandigarh
Block D , Level 5
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, GMCH , Chandigarh |
| 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 Apurva Rathour |
Government Medical College and Hospital , Chandigarh |
Department of Anaesthesia and Intensive Care , Block D , Level 5
Chandigarh
CHANDIGARH |
6284916781
apurva.rt9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS CORE COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T885||Other complications of anesthesia, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine drug |
Dexmedetomidine 50 mcg (mixed with saline to a volume of 5ml) nebulization to group D (study group) will be administered using a nebuliser face mask with a continuous flow of oxygen at 8 L/min for 15 to 20 mins before induction of anaesthesia in supine position with head propped up (30-45) degree. |
| Comparator Agent |
Normal saline |
The control group (group C) will receive nebulization with 0.9 % normal saline (5 ml) for 15 to 20 mins before induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologist(ASA) physical status I and II.
2. Age group between 18 to 60 years. |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airway (Airway Difficulty Score>8).
2. Patients with a body mass index (BMI)>35kg/m2
3. Patients with uncontrolled hypertension.
4. Patients with known allergy to study drug.
6. Pregnant patients. |
|
|
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 |
| The primary aim will be to evaluate the effects on the heart rate and blood pressure response in adult patients. |
The time points will be the baseline parameters, before nebulization, after nebulization, 1 min after intubation, 5 min after intubation, 10 min after intubation and 2 hrs postop |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary aims will be to evaluate the postoperative pain and sore throat. |
The secondary aims will be evaluated 2 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
19/04/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Till date, numerous drugs and various routes have been tried to attenuate his stress response such as opioids, vasodilators, beta-blockers, calcium channel blockers, intravenous lignocaine, topical sprays, volatile agents, alpha 2 agonists but none of the agents proved to be ideal. Dexmedetomidine, a selective alpha 2 adrenoceptor agonist. is short acting and has sedative, hypnotic, anxiolytic, analgesic, anti-sialagogue, sympatholytic properties and promotes cardiac, respiratory and neurological stability. It’s pleiotropic effects have led to its increasing use in the perioperative period. Dexmedetomidine has the potential to produce bradycardia and hypotension when administered as a bolus. In a way to overcome this problem, nebulization route was chosen. Moreover, nebulized dexmedetomidine has a bioavailability of 65% through the nasal mucosa and 82% through the buccal mucosa.. Nebulised drug administration may be preferred over intranasal administration, as it avoids transient nasal irritation, cough, vocal cord irritation or laryngospasm. However, limited number of studies are available on the usefulness of the dexmedetomidine drug nebulization on the haemodynamic response to laryngoscopy and intubation. Thus, the primary aim of this study will be to evaluate the effect of preoperative dexmedetomidine nebulization on the heart rate and blood pressure response to laryngoscopy and intubation in adult patients. The secondary aim is to evaluate time to extubation and a 2 hour incidence of postoperative pain and sore throat. |