| CTRI Number |
CTRI/2024/09/073995 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Nebulised dexmedetomidine efficacy in reducing haemodynamic response to laryngoscopy and intubation. |
|
Scientific Title of Study
|
Evaluation of efficacy of nebulised dexmedetomidine in attenuation of haemodynamic response to laryngoscopy and intubation. |
| 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 Tarandeep Singh Bajwa |
| Designation |
post graduate student |
| Affiliation |
Maharishi markandeshwar medical college and hospital |
| Address |
Department of Anaesthesia,
Maharishi Markandeshwar Medical college and Hospital,Kumarhatti,solan
solan ,Himachal Pradesh
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
919876388963 |
| Fax |
|
| Email |
Taranbajwa1414@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin k Gupta |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Medical college and Hospital |
| Address |
Department of Anaesthesia,Maharishi Markandeshwar Medical College and Hospital,Kumarhatti,solan
solan,himachal Pradesh.
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9877484849 |
| Fax |
|
| Email |
sachinkg78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tarandeep Singh Bajwa |
| Designation |
post graduate student |
| Affiliation |
Maharishi markandeshwar medical college and hospital |
| Address |
Department of Anaesthesia,
Maharishi Markandeshwar Medical college and Hospital,Kumarhatti,solan
solan ,Himachal Pradesh
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
919876388963 |
| Fax |
|
| Email |
Taranbajwa1414@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar medical college and Hospital,Kumarhatti,solan,Himachal Pradesh,INDIA. PIN code-173229 |
|
|
Primary Sponsor
|
| Name |
Dr Tarandeep Singh Bajwa |
| Address |
Department of Anaesthesia,Maharishi Markandeshwar medical college and Hospital,Kumarhatti,solanHimachal Pradesh,INDIA. PIN code-173229 |
| Type of Sponsor |
Other [self] |
|
|
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 Tarandeep singh bajwa |
Maharishi Markandeshwar medical college and Hospital,Kumarhatti,solan |
o.t complex, third floor ,Department of Anaesthesia,Maharishi Markandeshwar medical college and Hospital,Kumarhatti,solan
Solan
HIMACHAL PRADESH |
9876388963
taranbajwa1414@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar medical college and hospital |
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 |
Nebulised dexmedetomidine will be given and attenuation of haemodynamic response to laryngoscopy and intubation will be recorded. |
Nebulised Dexmedetomidine will be given at a dosage of 1 mcg/kg that is to be mixed with the saline to a total volume of 5 ml and the nebulisation will be administered with nebuliser facemask for the time period of 10 min before the induction of anaesthesia in the sitting position and response will be noted at time.
Injections of midazolam (30 mcg/kg), glycopyrrolate (10 mcg/kg), and nalbuphine (0.1 mg/kg)
will be used to premedicate patients. They will also be preoxygenated for three minutes, induced
with propofol (2 mg/kg), monitored for dosage amounts until verbal response is lost, and given
vecuronium (0.1 mg/kg) as a muscle relaxant to aid in intubation.
The consultant anesthesiologist will do a direct laryngoscopy (with the proper-sized Macintosh
blade), intubate the patient using an appropriately-sized endotracheal tube, and then link them to
a ventilator 10 minutes after intubation, the critical indicators such as the heart rate , the blood
pressure (systolic , diastolic and the mean arterial pressure will be noted by the baseline vitals,
the post-nebulization (post-neb), and the post-intubation at 1, 5, and 10 minutes will be recorded
by an anaesthesia resident who is not currently participating in the project. Diclofenac 75 mg
injections will be given intraoperatively to all patients. After the surgery, the neuromuscular
blockade will be removed by injecting glycopyrrolate and neostigmine. The patient will then be
extubated if they have met the extubation requirements, and they will then be sent to the post-anesthesia care unit. |
| Comparator Agent |
Evaluation of efficacy of nebulised normal saline in attenuation of haemodynamic response to laryngoscopy and intubation. |
Normal saline 5 ml nebulisation will be administered with a nebuliser face mask for time period of 10 minute before induction of anesthesia in sitting position.Injections of midazolam (30 mcg/kg), glycopyrrolate (10 mcg/kg), and nalbuphine (0.1 mg/kg)
will be used to premedicate patients. They will also be preoxygenated for three minutes, induced
with propofol (2 mg/kg), monitored for dosage amounts until verbal response is lost, and given
vecuronium (0.1 mg/kg) as a muscle relaxant to aid in intubation.
The consultant anesthesiologist will do a direct laryngoscopy (with the proper-sized Macintosh blade), intubate the patient using an appropriately-sized endotracheal tube, and then link them to a ventilator 10 minutes after intubation, the critical indicators such as the heart rate , the blood pressure (systolic , diastolic and the mean arterial pressure will be noted by the baseline vitals, the post-nebulization (post-neb), and the post-intubation at 1, 5, and 10 minutes will be recorded
by an anaesthesia resident who is not currently participating in the project. Diclofenac 75 mg .Injections will be given intraoperatively to all patients. After the surgery, the neuromuscular
blockade will be removed by injecting glycopyrrolate and neostigmine. The patient will then be extubated if they have met the extubation requirements, and they will then be sent to the post-anesthesia care unit. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
o American Society of Anaesthesiologists class 1 and 2 patients.
o Mallampati Grading I and II.
o Undergoing elective surgery under general anaesthesia and endotracheal intubation needed.
o Patient between age 18 to 60 years. |
|
| ExclusionCriteria |
| Details |
o American Society of Anaesthesiologists class III and IV.
o Patient not consenting for the study.
o Predicted difficulty airway.
o Known allergy to dexmedetomidine
o Patient on B-blockers
o Pregnant females.
o Kidney failure
o Uncontrolled hypertensive patient
o Seizure disorders.
o Patient taking medications such as anti-depressants or anti-psychotics.
o Patients with decrease cardiac output.
o Obese patient with Body mass index of more than 30 kg/metre square.
. |
|
|
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 |
Study is to evaluate the two groups in order to assess the following
VITALS: heart rate, systolic and diastolic blood pressure, mean arterial pressure. |
Heart rate , the blood
pressure (systolic , diastolic and the mean arterial pressure will be noted by the baseline vitals, the post-nebulization (post-neb), and the post-intubation at 1, 5, and 10 minutes will be noted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study any adverse effect of drug such as bradycardia,, hypotension, coughing and sore throat. |
In postoperative ward after extubation. |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
22/09/2024 |
| 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="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
|
To evaluate the effect of nebulised dexmedetomidine in attenuation of haemodynamic response to laryngoscopy and intubation.Nebulised dexmedetomidine will be given at dosage of 1mcg/kg that is to be mixed with the saline to a total volume of 5 ml and the nebulisation will be given with the nebulisation mask for period of 10 min in sitting position before induction of anesthesia .Injection of midazolam 30 mcg/kg ,injection Glycopyrollate 20 mcg/kg,and Nalbuphine 0.1mg/kg will be given to premedicate the patient .Patient will also be pre oxygenated for 3 minutes and propofol at a dose of 2 mg/kg will be given to induce the patient and patient will be monitored for doseage amounts until verbal response is lost and given vecuronium at dose 0.1mg/kg as a muscle relaxant to help in the intubation.Consultant anaesthesiologist will do Direct laryngyoscopy with appropriate size Macintosh blade and intubate the patient using appropriate size endotracheal tube and link It to the ventilator 10 minutes after intubation , the critical indicators such as THE HEART RATE ,THE BLOOD PRESSURE{ SYSTOLIC BLOOD PRESSURE,DIASTOLIC PRESSURE,MEAN ARTERIAL PRESSURE)will be noted via the baseline vitals.Post nebulisation and post intubation at 1 minute,5 minute ,10 minute by an anesthesia resident who is not currently participating in the project.Diclofenac 75 mg injection will be given intraopertively to all patients.After surgery the neuromuscular blockade will be removed by injection glycopyrollate and neostigmine and then patient will be extubated if they have met the extubation requirement and they will then be send to the post anesthsia care unit. |