| CTRI Number |
CTRI/2018/07/014901 [Registered on: 17/07/2018] Trial Registered Prospectively |
| Last Modified On: |
13/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON BETWEEN TWO DRUGS TO CHECK THE EFFECTIVENESS ON HEMODYNAMIC PARAMETERS |
|
Scientific Title of Study
|
A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY OF INTRAVENOUS DEXEMEDETOMIDINE VERSUS MAGNESIUM SULPHATE [MgSO4] AS AN ADJUNCT DURING ANAESTHESIA FOR LAPROSCOPIC CHOLECYSTECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shailee shah |
| Designation |
3 RD YEAR RESIDENT,ANESTHESIA |
| Affiliation |
SSG HOSPITAL,VADODARA |
| Address |
DEPARTMENT OF ANESTHESIA,SSG HOSPITAL,VADODARA
ROOM NO.58,NRMO HOSTEL,JAIL ROAD ,VADODARA
Vadodara
GUJARAT
390020
India |
| Phone |
9737458589 |
| Fax |
|
| Email |
dr.shahshailee16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEVYANI DESAI |
| Designation |
ASSOCIATE PROFESSOR,ANESTHESIA |
| Affiliation |
SSG HOSPITAL,VADODARA |
| Address |
DEPARTMENT OF ANESTHESIA,SSG HOSPITAL,VADODARA
DEPARTMENT OF ANESTHESIA,SSG HOSPITAL,,VADODARA
Vadodara
GUJARAT
390020
India |
| Phone |
9909983168 |
| Fax |
|
| Email |
devyani.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shailee shah |
| Designation |
3 RD YEAR RESIDENT,ANESTHESIA |
| Affiliation |
SSG HOSPITAL,VADODARA |
| Address |
DEPARTMENT OF ANESTHESIA,SSG HOSPITAL,VADODARA
ROOM NO.58,NRMO HOSTEL,JAIL ROAD ,VADODARA
Vadodara
GUJARAT
390020
India |
| Phone |
9737458589 |
| Fax |
|
| Email |
dr.shahshailee16@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SSG HOSPITAL VADODARA |
| Address |
DEPARTMENT OF ANAESTHESIA
SSG HOSPITAL VADODARA |
| 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 |
| SHAILEE SHAH |
SSG HOSPITAL ,VADODARA |
C1,C2,C3,C4,D1,D2,D3,D4 SURGICAL WARD ,NEW SURGICAL BLOCK ,SSG HOSPITAL VADODARA
Vadodara
GUJARAT |
9737458589
dr.shahshailee16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Human Research, Medical College Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ATTENUATION DURING ANESTHESIA IN LAPROSCOPIC CHOLECYSTECTOMY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INJ DEXMEDETOMIDINE
|
Inj Dexmedetomidine 1mcg/kg over 15 min in 20 ml NS intravenously
|
| Intervention |
Inj magnesium sulphate |
Inj magnesium sulphate 40mg/kg over 15 min in 20 ml NS intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Age Group 18 -65years
2 ASA status I & II
3 Male / female
Patients posted for laparoscopic cholecystectomy
|
|
| ExclusionCriteria |
| Details |
• Anticipated difficult airway and obesity
• Patient having allergy to study drug
• Patient with systemic diseases like severe hypertension, cardiovascular, respiratory, neurological, psychological, hepatic, renal disease (diagnosed by clinical judgments and investigations) and on medication of above mentioned diseases
• Patients with heart rate <60 beats/mi
• Pregnant or lactating females
• Patients who refuse to give consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It will be expected that both drugs will be effectively able to attenuate hemodynamic stress response during anaesthesia for laparoscopic cholecystectomy with CO2 pneumoperitoneum |
1. Baseline
2. Before and after infusion
3. Before and after intubation
4. Before and after Pneumoperitoneum
5. After release of Pneumoperitoneum
6. After Extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1Amount of induction agent used
2Post-operative sedation –Ramsay sedation score
• Post-operative Analgesia-Visual analogue scale |
1min,15min,30min,60min,120min |
|
|
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 |
|
Date of First Enrollment (India)
|
25/07/2018 |
| 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="10"
Days="30" |
|
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
|
70 patients of ASA status 1 and 2 ,aged between 18 to 65 years ,of either sex ,scheduled for laparoscopic cholecystectomy were randomized in 2 groups (group D and group M)in a single blind fashion ,to receive either dexmedetomidine1mcg/kg,magnesium sulphate 40mg/kg in normal saline iv respectively .Total volume of the study drug was adjusted to 20 ml and administered over 15 mins before induction .Aesthesia was induced with propofol till loss of eyelid reflex followed by inj succinylcholine 2mg/kg. Laryngoscopy and intubation were done with appropriate size mac intosh blade and endotracheal tube .Hemodynamic parameters of patients including HR,SBP,RPP,MAP,SPO2,ETCO2,ECG were recorded at different time interval as below
1 baseline
2 before ad after infusion
3 after intubation
4 after pneumoperitoneum
5 after release of pneumoperitoneum
6 after extubation. Post operative sedation and analgesia were assessed.
|