| CTRI Number |
CTRI/2020/09/027772 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
04/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON BETWEEN DEXMEDETOMIDINE AND MAGNESIUM SULPHATE ON STRESS RESPONSE IN LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA. |
|
Scientific Title of Study
|
COMPARISON OF DEXMEDETOMIDINE AND MAGNESIUM SULPHATE ON STRESS RESPONSE IN ADULT PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivam Jaisawal |
| Designation |
PG Resident |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesiology, ABVIMS and Dr. RML Hospital.
New Delhi
DELHI
110001
India |
| Phone |
7873657121 |
| Fax |
|
| Email |
shivamjaiswal88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar Nagpal |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesiology, ABVIMS and Dr. RML Hospital.
New Delhi
DELHI
110001
India |
| Phone |
9968304240 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam Jaisawal |
| Designation |
PG Resident |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesiology, ABVIMS and Dr. RML Hospital.
New Delhi
DELHI
110001
India |
| Phone |
7873657121 |
| Fax |
|
| Email |
shivamjaiswal88@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. RML Hospital |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Ram
Manohar Lohia Hospital, Type III, Connaught Place, New Delhi,
Delhi, India-110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivam Jaisawal |
ABVIMS and Dr RML Hospital |
3rd floor, Department of Anaesthesiology, PGIMER building
New Delhi
DELHI |
7873657121
shivamjaiswal88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E898||Other postprocedural endocrine andmetabolic complications and disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Patient will be brought to the operation theatre, dexmedetomidine 1 µg/kg (2 ml diluted in 48 ml normal saline to make total 50 ml) will be given over 15 minutes through infusion pump. After 15 minutes of test drug injection general anaesthesia will be induced. |
| Comparator Agent |
Magnesium sulphate |
Patient will be brought to the operation theatre, magnesium sulphate 50 mg/kg diluted to make 50 ml with normal saline will be given over 15 minutes through infusion pump. After 15 minutes of test drug injection general anaesthesia will be induced. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I patients posted for elective laparoscopic cholecystectomy under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Hypermagnesaemia.
2. A known allergy to magnesium sulphate.
3. Any degree of heart block
4. Hypertensive or diabetic patients.
5. Acute cholecystitis.
6. Hemodynamically unstable patients
7. Pregnancy
8. BMI > 30 kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Biochemical markers of stress response (CORTISOL, TSH, INSULIN, TNF alpha, CRP and BLOOD SUGAR) |
1) baseline sample at 8 AM
2) intra operative- 20 minutes after pneumoperitoneum
3) 4 hours after reversal of anaesthesia
4) 24 hours after reversal of anaesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic response to pneumoperitoneum (HR, MAP, RR, SpO2) |
Preoperative, 1 minute, 5 minutes and 20 minutes after creating pneumoperitoneum. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2020 |
| 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="1"
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)?
Response - NO
|
|
Brief Summary
|
This Randomized, Comparative study between dexmedetomidine and magnesium sulphate on stress response will be conducted in the Department of Anaesthesiology, ABVIMS and Dr RML hospital, New Delhi-110001.The study will include 60 adult patients (30 in each group) undergoing laparoscopic cholecystectomy under general anaesthesia. The primary outcome of this study is to measure biochemical markers of stress response in venous sample at specified intervals. The secondary outcome will be hemodynamic response to pneumoperitoneum seen at specified time intervals. |