| CTRI Number |
CTRI/2018/04/012985 [Registered on: 03/04/2018] Trial Registered Prospectively |
| Last Modified On: |
02/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Dexmedetomidine with Magnesium Sulphate for preventing the increase in blood pressure and heart rate that occur at the time of endotracheal tube insertion in adult patients |
|
Scientific Title of Study
|
Comparison of infusion Dexmedetomidine with Magnesium Sulphate for attenuation of the haemodynamic response during endotracheal intubation in adult patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikita Choudhary |
| Designation |
Post Graduate |
| Affiliation |
Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesiology and Intensive Care,
Ground Floor, Main OT Building, Vardhman Mahavir
Medial College and Safdarjung Hospital New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9891122144 |
| Fax |
|
| Email |
choudhary.20nikita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajpal Singh |
| Designation |
Professor, Department of Anaesthesia & Intensive Care |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Anaesthesiology and Intensive Care,
Ground Floor, Main OT Building, Vardhman Mahavir
Medial College and Safdarjung Hospital New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9911858311 |
| Fax |
|
| Email |
doctorrajpal04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Choudhary |
| Designation |
Post Graduate |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Anaesthesiology and Intensive Care,
Ground Floor, Main OT Building, Vardhman Mahavir
Medial College and Safdarjung Hospital New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9891122144 |
| Fax |
|
| Email |
choudhary.20nikita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi
110029 India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi |
| Address |
Department of Anaesthesiology and Intensive care, Ground floor,
Main OT building, Vardhman Mahavir Medical College and
Safdarjung Hospital. New Delhi-110029 |
| 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 Nikita Choudhary |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
Department of Aaesthesiology and Intensive Care,
Ground Floor, Main OT Building,Safdarjung Hospital New Delhi
New Delhi
DELHI |
9891122144
choudhary.20nikita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
AGE 18-60YEARS OF EITHER SEX, ASA GRADE I AND II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group in which no study drug is given before induction of general anaesthesia & endotracheal intubation. |
just before induction of anaesthesia 50 ml of normal saline over 10 minutes is given to patients. No study drug given in this group. Haemodynamic parameters are noted. Then induction of anaesthesia is to be done with injection fentanyl 2ucg/kg, injection propofol 1.5mg/kg, injection vecuronium 0.12mg/kg. Then IPPV to be done for 4 minutes with nitrous oxide & oxygen 50:50. Then endotracheal intubation done with direct laryngoscopy, bilateral air entry check & tube fix. Now haemodynamic parameters are to be note till 10min after intubation. |
| Intervention |
Dexmedetomidine infusion before induction of anaesthesia for attenuation of endotracheal intubation response |
Just before induction of anaesthesia dexmedetomidine (1 ucg/kg)in 50ml of NS over 10 minutes is given to patient.Haemodynamic parameters are noted. Then induction of anaesthesia is to be done with injection fentanyl 2ucg/kg, injection propofol 1.5mg/kg, injection vecuronium 0.12mg/kg. Then IPPV to done for 4 minutes with nitrous oxide & oxygen 50:50. Then endotracheal intubation done with direct laryngoscopy, bilateral air entry check & tube fix. Now haemodynamic parameters are to be note till 10min after intubation. |
| Intervention |
Magnesium sulphate infusion before induction of general anaesthesia for attenuation of endotracheal intubation response |
Just before induction of anaesthesia magnesium sulphate 50mg/kg in 50 ml of normal saline over 10min is given to patients. Haemodynamic parameters are noted. Then induction of anaesthesia is to be done with injection fentanyl 2ucg/kg, injection propofol 1.5mg/kg, injection vecuronium 0.12mg/kg. Then IPPV to done for 4 minutes with nitrous oxide & oxygen 50:50. Then endotracheal intubation done with direct laryngoscopy, bilateral air entry check & tube fix. Now haemodynamic parameters are to be note till 10min after intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I & II patients with mallampatti grades I & II |
|
| ExclusionCriteria |
| Details |
1)Allergy to study medication
2)Difficult airway or Intubation time more than 20 seconds or more than one attempt
3)Hypertensive,Cardiac,Hepatic,Renal,Endocrine,Psychiatric disease & Morbid obesity
4) Pregnant & Nursing women |
|
|
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 |
| To compare the efficacy of infusion Dexmedetomidine with magnesium sulphate on haemodynamic parameters (HR & BP) during endotracheal intubation in adult patients |
At the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of dexmedetomidine & magnesium sulphate on:
1)Sedation
2)Requirement of neuromuscular blocking agent
3) Recovery characteristics
|
At the time of intubation, during the surgery, and
post operative period |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
10/04/2018 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1) To compare the efficacy of infusion Dexmedetomidine with magnesium sulphate on haemodynamic parameters during endotracheal intubation in adult patients 2) To study the effect of dexmedetomidine & magnesium sulphate infusion on post operative sedation, requirement of neuromuscular blocking agent & recovery characteristics.
Hypothesis- Dexmedetomidine infusion before induction will attenuate haemodynamic response to tracheal intubation better than magnesium sulphate infusion. |