| CTRI Number |
CTRI/2020/04/024931 [Registered on: 30/04/2020] Trial Registered Prospectively |
| Last Modified On: |
28/04/2020 |
| 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
|
: Comparison of the action of of Dexmedetomidine and Magnesium
Sulphate on Blood pressure and heart rate during laparoscopic surgeries.
|
|
Scientific Title of Study
|
Comparative study of the effects of Dexmedetomidine and Magnesium sulphate on hemodynamics during laparoscopic surgeries
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neethu P Antony |
| Designation |
Junior resident |
| Affiliation |
St.Johns medical college Hospital |
| Address |
Department of anesthesiology
St Johns Medical College hospital
Koramangala
Bangalore -34
Bangalore
KARNATAKA
560034
India |
| Phone |
8884636709 |
| Fax |
|
| Email |
annchristychf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surbhi Gupta |
| Designation |
Associate Professor |
| Affiliation |
St.Johns medical college |
| Address |
Department of anesthesiology
St Johns Medical College hospital
Koramangala
Bangalore -34
Bangalore
KARNATAKA
560034
India |
| Phone |
98801019361 |
| Fax |
|
| Email |
surbhi_pg@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Surbhi Gupta |
| Designation |
Associate Professor |
| Affiliation |
St.Johns medical college |
| Address |
Department of anesthesiology
St Johns Medical College hospital
Koramangala
Bangalore -34
KARNATAKA
560034
India |
| Phone |
98801019361 |
| Fax |
|
| Email |
surbhi_pg@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St.Johns medical college hospital
Koramangala
Sarjapur road. Bangalore-34 |
|
|
Primary Sponsor
|
| Name |
StJohns Medical college |
| Address |
St.JohnsMedical college
Koramangala
Bangalore-34
|
| 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 |
| Neethu P Antony |
second floor operation theatre, preoperative room. room no 1,2,4.m |
St.Johns medical college hospital
koramangala
Bangalore-34
Bangalore
KARNATAKA |
8884636709
annchristychf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,SJMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K811||Chronic cholecystitis, (3) ICD-10 Condition: N979||Female infertility, unspecified, (4) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (5) ICD-10 Condition: O||Medical and Surgical, (6) ICD-10 Condition: N139||Obstructive and reflux uropathy, unspecified, (7) ICD-10 Condition: K36||Other appendicitis, (8) ICD-10 Condition: N950||Postmenopausal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
1mcg/kg diluted in 100 ml Normal saline as slow IV 15 minutes prior to induction of anaesthesia |
| Comparator Agent |
Magnesium Sulphate |
30 mg/kg diluted in 100 ml normal saline as slow IV 15 minutes prior to induction of anaesthesia |
| Comparator Agent |
Placebo |
100 ml of normal saline 15 minutes prior to induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex undergoing elective laparoscopic surgeries,ASA I and II, Age between 20 -59 years and Patients with Mallampatti grade I or II
|
|
| ExclusionCriteria |
| Details |
• Any known allergy to the study drug
• Pregnant women
• BMI >35 kg/cm2
• Patients with pre-existing neuromuscular disease.
• Patients with anticipated difficult airway.
• More than one intubation attempt
• Baseline heart rate< 60/ minute
• Patients on beta- blockers and calcium channel blockers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of intravenous Dexmedetomidine and Magnesium sulphate on hemodynamic changes occurring during laryngoscopy, intubation and during pneumoperitoneum in laparoscopic surgeries. |
15 minutes prior to induction, at the time of induction, laryngoscopy ,1,3,5,10 minutes after intubation, at the time of pneumoperitoneum , 1,5,10, 30 minutes after pneumoperitoneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess any associated side effects like hypotension, bradycardia, dry mouth, nausea vomiting and allergic reactions. |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
28/05/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dexmedetomidine is an imidazole derivative and is highly selective alpha -2- adrenergic agonist . Alpha -2- agonist act on vascular pre-junctional terminals leading to decreased systemic noradrenaline release causing a decrease in blood pressure. it is known to attenuate the hypertensive response associated with intubation and pneumoperitoneum. Administered as a bolus dose 0.5-1 mcg/kg intravenously over 10-15 minutes. as infusion 0.1-1.5 mcg.kg/minute. it undergoes extensive biotransformation in liver and excreted through urine. there is no absolute contra indication to its use. side effects include hypotension, bradycardia, dry-mouty, hyperbilirubinimia, increased alanine transaminase and aspartate transferase. Magnesium sulphate is a physiological and pharmacological blocker of N-methyl -D-aspartate receptors in neuronal tissue. Directly blocks the release of catecholamines from adrenal gland and adrenergic nerve terminals and indirectly by negative feed mechanism. it lso acts on blood vessels leading to vasodilation and decrease vasopressin stimulated vasoconstriction.parental magnesium sulphate has been used for many years as anti arrhythmic agents , for prophylaxis against seizure in pre-eclampsia patients.in the last decades its importance in anesthetic practice has been highlighted. side effects are nausea, vomiting, hypotension, head ache, lethargy. it can also potentiate neuromuscular blocking agents thus delaying the recovery. both these drugs can attenuate the hemodynamic stress response to laryngoscopy, intubation and pneumoperitoneum in patients undergoing laparoscopic surgeries. |