| CTRI Number |
CTRI/2024/08/072702 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial of comparison between dexmedetomidine and magnesium sulphate given by nebulisation to patients in reducing body response following larygoscopy and intubation response. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF NEBULISED DEXMEDETOMIDINE AND NEBULISED MAGNESIUM SULPHATE ON ATTENUATION OF PRESSOR RESPONSE FOLLOWING 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 Krishna A Sivan |
| Designation |
DNB Resident, Department of Anaesthesiology |
| Affiliation |
Hindu Rao Hospital and North DMC medical college |
| Address |
Department of Anaesthesiology and Perioperative medicine,Hindu Rao Hospital and North DMC medical college, Gandhi Square, Malka ganj, Delhi
Central
DELHI
110007
India |
| Phone |
7907280569 |
| Fax |
|
| Email |
krishnaasivan9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Aggarwal |
| Designation |
CMO(SAG), Department of Anaesthesiology |
| Affiliation |
Hindu Rao Hospital and North DMC medical college |
| Address |
Department of Anaesthesiology and Perioperative medicine,Hindu Rao Hospital and North DMC medical college, Gandhi Square, Malka ganj, Delhi
Central
DELHI
110007
India |
| Phone |
7982024475 |
| Fax |
|
| Email |
Megha91082@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Aggarwal |
| Designation |
CMO(SAG), Department of Anaesthesiology |
| Affiliation |
Hindu Rao Hospital and North DMC medical college |
| Address |
Department of Anaesthesiology and Perioperative medicine, Hindu Rao Hospital and North DMC medical college, Gandhi Square, Malka ganj, Delhi
Central
DELHI
110007
India |
| Phone |
7982024475 |
| Fax |
|
| Email |
Megha91082@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DNB fund,Hindu Rao Hospital and North DMC medical college,Gandhi Square,Malka Ganj,Delhi,110007, India |
|
|
Primary Sponsor
|
| Name |
Hindu Rao Hospital and North dmc medical college DNB fund |
| Address |
Hindu rao hospital and north DMC medical college,Gandhi Square, Malka Ganj, Delhi, 110007 |
| 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 Krishna A Sivan |
Hindu Rao Hospital |
Department of anaesthesiology, Critical care and Perioperative medicine,
Hindu Rao Hospital and North DMC medical college, Gandhi Square, Malka ganj, Delhi, 110007
Central
DELHI |
7907280569
krishnaasivan9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,North DMC Medical college and Hindu Rao 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 |
Nebulisation with dexmedetomidine |
Dexmedetonidine is an alpha 2 agonist which provides sedation, sympatholysis, analgesia, opioid and anaesthetic sparing effect.Trial to assess the attenuation of pressor response following laryngoscopy and intubation by nebulisation with dexmedetomidine.Nebulisation with dexmedetomidine at a dose of 1mcg/kg commencing 30 min before the patient is shifted to OT.Nebulisation will be done in shifting position with a nebulisation face mask and a continuous flow of 100% oxygen at 6L/min till the entire volume is dispersed amd there is no further mist on tapping the chamber. |
| Comparator Agent |
Nebulisation wuth magnesium sulphate. |
Magnesium sulphate is an antagonist of the NDMA receptors and prevents central sensitization of the peripherally inflicted nociceptive stimuli. Trial to assess the attenuation of pressor response following laryngoscopy and intubation by nebulisation with magnesium sulphate.Nebulisation with magnesium sulphate at a dose of 30mg/kg commencing 30 min before the patient is shifted to OT.Nebulisation will be done in shifting position with a nebulisation face mask and a continuous flow of 100% oxygen at 6L/min till the entire volume is dispersed and there is no further mist on tapping the chamber. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient weighing between 50-80 kilograms.
Patients belonging to ASA Grade I and Grade II.
Patients undergoing elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients of uncontrolled hypertension, ischemic heart disease, AV blocks, arrhythmoas, ventricular dysfunction.
Patients wuth hepatic and renal dysfunction.
Patients of anticipated difficult airway.
Patients allergic to the stidy drug.
Patient unwilling to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic paramater- Heart rate, following intubation in either groups |
10 mins post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare other hemodynamic paramters - Systolic blood pressure, Diastolic blood pressure and mean arterial pressure in either groups. |
10 mins post intubation |
| To compare the occurrence and severity of postoperative sore throat in either group. |
Within one hour in recovery area |
| To compare the total dose of propofol required for intubation in either group. |
2-3 mins before intubation |
| To compare postoperative sedation in either group |
Within one hour in recovery room |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="2"
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
|
This is prospective interventional double blind randomized comparative study of the effect of nebulised dexmedetomidine and magnesium sulphate on attenuation of pressor response following laryngoscopy and intubation that will be conducted under Department of Anaesthesiology, Critical Care and Perioperative medicine, Hindu Rao hospital and associated NDMC, Delhi, India. The primary outcome is the comparison of heart rate following intubation in either group within 10 mins post intubation. The secondary outcome is the comparison of other hemodynamic paramters - Systolic blood pressure, Diastolic blood pressure and mean arterial pressure in either groups within 10 mins post intubation, and to compare the occurrence and severity of postoperative sore throat ineither group ;to compare total dose of propofol required for intubation in either group and to compare postoperative sedation in either group |