| CTRI Number |
CTRI/2024/02/062361 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Randomized control trial comparing three different group of drugs which can better decrease stress response to putting a tube in patients trachea for proper lung ventilation during general anaesthesia in laparoscopic surgery. |
|
Scientific Title of Study
|
A Randomized Control Trial comparing intravenous magnesium sulphate, dexmedetomidine and labetalol for attenuation of cardiovascular stress response during endotracheal intubation in laparoscopic surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANISHA RATNAM |
| Designation |
Postgraduate (MD Anaesthesiology) |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
R-204,Abode Valley, 54 kakkan street, Potheri,kattankulathur, Chengalpattu Tamil nadu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8789923313 |
| Fax |
|
| Email |
manisha.ratnam23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K KARTHIK |
| Designation |
Professor department of anaesthesiology |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
B/206,2nd floor department of anaesthesiology SRM medical college hospital and research centre kattankulathur Chengalpattu Tamil nadu.
Kancheepuram
TAMIL NADU
603211
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
karthikkrishnamoorthy1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K KARTHIK |
| Designation |
Professor department of anaesthesiology |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
B/206 2nd floor department of anaesthesiology SRM medical college hospital and research centre kattankulathur Chengalpattu Tamil nadu.
Kancheepuram
TAMIL NADU
603211
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
Karthikkrishnamoorthy1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital And Research Centre. |
|
|
Primary Sponsor
|
| Name |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
B-206, 2nd floor,department of anaesthesiology ,srm medical college hospital and research centre,kattankulathur ,Kancheepuram,Tamil nadu |
| 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 |
| DrkKarthik |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
B-206, department of anaesthesiology, srm medical college hospital and research centre
Kancheepuram
TAMIL NADU |
9884360796
Karthikkrishnamoorthy1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM INSTITUTIONAL ETHICS COMIMITTEE- STUDENTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A RANDOMIZED CONTROL TRIAL |
A RANDOMIZED CONTROL TRIAL COMPARING INTRAVENOUS MAGNESIUM SULPHATE,DEXMEDETOMIDINE AND LABETALOL FOR ATTENUATION OF CARDIOVASCULAR STRESS RESPONSE DURING ENDOTRACHEAL INTUBATION IN LAPAROSCOPIC SURGERIES |
| Comparator Agent |
Comparison between intravenous magnesium sulphate,dexmedetomidine and labetalol for attenuation of cardiovascular stress response during endotracheal intubation in laparoscopic surgery. |
Patient will be divided into four groups
Group M - 30mg/kg magnesium sulphate diluted in 100 ml normal saline via intravenous route 10min before intubation.
Group D- 1microgram/kg dexmeditomidine diluted in 100ml normal saline 10 min before intubation
Group L -Labetalol 0.15mg/kg in 100ml normal saline intravenous 10 min before
Intubation.
Group P 100ml normal saline 10 min before intubation in elective laparoscopic surgery. |
| Comparator Agent |
Comparison between intravenous magnesium sulphate,dexmedetomidine and labetalol for attenuation of cardiovascular stress response during endotracheal intubation in laparoscopic surgery. |
Patient will be divided into four groups
Group M - 30mg/kg magnesium sulphate diluted in 100 ml normal saline via intravenous route 10min before intubation.
Group D- 1microgram/kg dexmeditomidine diluted in 100ml normal saline 10 min before intubation
Group L -Labetalol 0.15mg/kg in 100ml normal saline intravenous 10 min before
Intubation.
Group P 100ml normal saline 10 min before intubation in elective laparoscopic surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)American society of anaesthesiologist grade 1 and 2 patients.
2)Patients undergoing elective laparoscopic surgeries.
|
|
| ExclusionCriteria |
| Details |
1)patients refusal
2)Heart rate<60/min
3)systolic blood pressure of <100mmhg
4)Mallampatti grading 3 and 4
5) anticipated difficult intubation.
6)patients with systemic disorders like Left ventricular failure,any degree of heart block,ischemic heart disease,aortic stenosis and bronchial asthama.
|
|
|
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 monitor change in heart rate during laryngoscopy and endotracheal intubation,and which drug is the best in blunting hemodynamic stress response during endotracheal intubation. |
T0:Base line HR,BP,Spo2
T1:After induction
T2:Before laryngoscopy
T3:Immediately after laryngoscopy and intubation
T4:2 mins after intubation
T5:5mins after intubation
T6:Before pneumoperitoneum
T7:2mins after pneumoperitoneum
T8:5mins after pneumoperitoneum
T9:10mins after pneumoperitoneum
T10 :Before intubation
T11:Immediately after extubation.
T12:5mins after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To monitor change in blood pressure during laryngoscopy and intubation.
2)Requirement of analgesic supplementation intraoperatively.
3)Level of sedation at the time of extubation |
Be will also be recorded along with heart rate.
Every 30 mins post intubation .
Level of sedation at the time of extubation will be assessed with the help of riker sedation agitation scale. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="30"
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)
|
20/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2024 |
| 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
|
This study is to compare between intravenous Magnesium Sulphate, Dexmedetomidine and Labetalol for attenuation of cardiovascular stress response during laryngoscope and endotracheal intubation in laparoscopic surgeries by monitoring change in heart rate and blood pressure. A total of 120 patients of ASA status 1 and 2 aged 18-60 years of age, of either sex undergoing elective laparoscopic surgeries under general anaesthesia requiring endotracheal intubation will be selected and then divided into 4 groups of 30 each. 1st group will be given Magnesium sulphate, 2nd group Dexmedetomidine , 3rd group Labetalol and 4th group 10 ml Normal saline to act as control. The attenuation of cardiovascular stress response will be compared among different groups. |