| CTRI Number |
CTRI/2024/03/063949 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of effect of nebulized dexmeditomidine on attenuating the hemodynamic response to intubation during entropy targeted anaesthesia. |
|
Scientific Title of Study
|
EVALUATION OF EFFECT OF NEBULISED DEXMEDETOMIDINE ON ATTENUATING THE HEMODYNAMIC RESPONSE TO INTUBATION DURING ENTROPY TARGETED ANAESTHESIA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivangi Sharma |
| Designation |
Anaesthesia Resident |
| Affiliation |
MM Institute of Medical Science and Research, Mullana, Ambala |
| Address |
Department of Anaesthesia, MM Institute of Medical Science and Research
MM(DU) CAMPUS, MULLANA, AMBALA, HARYANA.
Ambala
HARYANA
133207
India |
| Phone |
8506010663 |
| Fax |
|
| Email |
shivisharma97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakesh Kumar Anand |
| Designation |
Professor |
| Affiliation |
MM Institute of Medical Science and Research, Mullana, Ambala |
| Address |
Department of Anaesthesia, MM Institute of Medical Science and Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakesh Kumar Anand |
| Designation |
Professor |
| Affiliation |
MM Institute of Medical Science and Research, Mullana, Ambala |
| Address |
Department of Anaesthesia, MM Institute of Medical Science and Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, MM Institute of Medical Science and Research, Mullana, Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthsia |
| Address |
MM Institute of Medical Science and Research, Mullana, Ambala, Haryana |
| Type of Sponsor |
Private 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 Shivangi Sharma |
MM Institute of Medical Science and Research, Mullana, Ambala, Haryana |
Maharishi Markandeshwar Institute of Medical Science and Research, Mullana, Ambala, Haryana
Ambala
HARYANA |
8506010663
shivisharma97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MMIMSR, Mullana, Ambala, Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To study the effects of premedication with nebulised dexmedetomidine on blunting the haemodynamic response to laryngoscopy and tracheal intubation. |
Group C: Patient will be administered
Comparator agent: 5ml of normal saline
Route: via nebulization
Duration: for 5 minutes,
Time point: 10 minutes prior to induction of anaesthesia. |
| Intervention |
To study the effects of premedication with nebulised dexmedetomidine on blunting the haemodynamic response to laryngoscopy and tracheal intubation. |
Group D: Patient will be administered
Drug: Dexmedetomidine
Dose: 1μ/ kg body weight in 5ml normal saline
Route: nebulization
Duration: for 5 minutes
Time point: 10 minutes prior to induction of anaesthesia.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA 1 and 2 undergoing general surgery under general anaesthesia requiring tracheal intubation. |
|
| ExclusionCriteria |
| Details |
1) patients with body mass index more than 35 kg per meter square
2) patients with increased risk of aspiration of gastric contents
3) patients with airway difficulty score more than 8
4) patients with upper respiratory tract infection
5) patients with hepatic or renal insufficiency
6) patients with history of smoking or exposure to household smoke
7) patients taking medications which affect heart rate or blood pressure
8) 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 |
| Hemodynamic (heart rate, Blood pressure) response to laryngoscopy and tracheal intubation |
Hemodynamic (heart rate, Blood pressure) before nebulization (baseline), after nebulization, immediately after intubation, 1 minute after intubation, 5 minutes after intubation, 10 minutes after intubation, and at the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The dose requirement of propofol for induction of anaesthesia to achieve target entropy |
prior to and during induction of anaesthesia |
| incidence of postoperative sore throat. |
at the end of surgery and 30 minutes after the end of surgery |
|
|
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 4 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| 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="0"
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
|
Laryngoscopy and intubation are painful stimuli and can
cause unpredictable, transient, and variable haemodynamic changes. This
response happens within 30 seconds after intubation and lasts for about 10 min.
The consequences of laryngoscopy and intubation can include precipitation of
ischaemia, cerebrovascular stroke, increase in intracranial pressure,
arrhythmias, pulmonary oedema in the vulnerable patients. The efficacy of
dexmedetomidine in reducing the response to laryngoscopy and tracheal
intubation will be evaluated during this study.
Dexmedetomidine is a selective alpha 2 adrenoceptor agonist.
It has analgesic, hypnotic, sedative,
anxiolytic, , sympatholytic, and anti-sialagogue properties and promotes
cardiac, respiratory, and, neurological stability. Dexmedetomidine has the
potential to cause unwanted side effects like bradycardia and hypotension when
administered as an intravenous bolus.
Dexmedetomidine has additional benefit of reducing the dose
of anaesthetic used, which will also be evaluated during this study. The
anaesthetic sparing effect of dexmedetomidine has been studied via the
intravenous route in various studies.
This study aims to evaluate the effectiveness and safety of
nebulised dexmedetomidine premedication in attenuating the haemodynamic stress
response during laryngoscopy and tracheal intubation. The propofol sparing
effect of dexmedetomidine and its effect on postoperative sore throat will also
be studied during induction. |