| CTRI Number |
CTRI/2019/11/022158 [Registered on: 26/11/2019] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effects of Magnesium sulphate and low dose of Dexmedetomidine on haemodynamic responses to laryngoscopy and intubation |
|
Scientific Title of Study
|
Comparison of effects of Magnesium sulphate and low dose of Dexmedetomidine on haemodynamic responses 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 |
Dr Mahendra Kumar |
| Designation |
Director Professor |
| Affiliation |
UCMS and GTB hospital |
| Address |
Department of Anaesthesiology, Critical Care and Pain Medicine
UCMS and GTB hospital, Dilshad Garden,Delhi.
North East
DELHI
110095
India |
| Phone |
9868399709 |
| Fax |
|
| Email |
mahendramohit@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahendra Kumar |
| Designation |
Director Professor |
| Affiliation |
UCMS and GTB hospital |
| Address |
Department of Anaesthesiology, Critical Care and Pain Medicine
UCMS and GTB hospital, Dilshad Garden,Delhi.
North East
DELHI
110095
India |
| Phone |
9868399709 |
| Fax |
|
| Email |
mahendramohit@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kusum |
| Designation |
Postgraduate Student |
| Affiliation |
UCMS and GTB hospital |
| Address |
Department of Anaesthesiology, Critical Care and Pain Medicine
UCMS and GTB hospital, Dilshad Garden, Delhi
North East
DELHI
110095
India |
| Phone |
9354069382 |
| Fax |
|
| Email |
mamacsinghkusum92@gmail.com |
|
|
Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
UCMS and GTB hospital |
| Address |
Dilshad Garden, Delhi-110095 |
| 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 |
| Kusum |
UCMS and GTB Hospital |
Department of Anaesthesia and Critical Care and Pain Medicine/ OT block/4th,5th,6th,7th floor
North East
DELHI |
9354069382
mamacsinghkusum92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-HR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
0.25microgm/kg dexmedetomidine diluted to 100 ml of 0.9% Normal saline will be given Over a period of 10min before induction of anaesthesia |
| Comparator Agent |
Magnesium sulphate |
Magnesium will be given in dose of 50mg/kg diluted to 100 ml of 0.9% Normal saline will be given over a period 10 min before induction of anaesthesia. |
| Intervention |
Study drug will be administered before induction of anaesthesia |
study drug will be diluted to 100 ml on 0.9% normal saline and will be administered intravenously Over a period of 10 min before induction of anaesthesia |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing elective surgery under
general anaesthesia and requiring
laryngoscopy and endotracheal intubation
Patient belonging to ASA grade I and II
Patient with Mallampati grade I and II
Patient of either gender
Patient of age group 18-60 yrs
|
|
| ExclusionCriteria |
| Details |
Patient not willing to participate in the study
Patient with the history of difficult intubation
Patient with anticipated difficult airway
Patient having BMI>30kg/m2
Patient having history of cardiovascular, cerebral, renal, hepatic, bronchial, endocrine disease or psychiatric disorder
Patient on anti-hypertensive, hypnotic or narcotic drugs
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Difference in SBP following laryngoscopy and intubation in the two groups |
Preoperative (base line values) i.e. before infusion of study drug
During medication at 5min, 10min
Pre-induction of anaesthesia
Just before laryngoscopy and intubation
Post intubation at 1 min, 3min, 5min, 7min and 10min
Then every 5 min till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the heart rate between two groups following laryngoscopy and intubation
To compare Diastolic and Mean blood pressure between two groups
To compare post-operative pain by Numerical Rating score in two groups
To compare post-operative sedation score in two groups
|
Preoperative (base line values) i.e. before infusion of study drug
During medication at 5min, 10min
Pre-induction of anaesthesia
Just before laryngoscopy and intubation
Post intubation at 1 min, 3min, 5min, 7min and 10min
Then every 5 min till the end of surgery
|
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/11/2019 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
this study is purposed to find a suitable drug ( with minimum adverse effects) that can minimise the stress resposes like rise in blood pressure and heart rate during laryngoscopy and intubation in patients planned for surgical intervention under general anaesthesia. laryngoscopy and intubation can be fatal in patients with cardiovascular and cerebral diseases therefore this study will be focused first on ASA grade I and II patients so that it can further be studied on critically ill patients. It can be helpful in decreasing the mortality associated with the simple procedures like laryngoscopy and intubation.
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