| CTRI Number |
CTRI/2025/08/092504 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in patients undergoing laparoscopic surgery to compare the effects of Dexmedetomidine and Magnesium Sulfate on vital signs. |
|
Scientific Title of Study
|
A Comparative study of Adjunct Dexmedetomidine and Magnesium sulphate on Hemodynamic response during Laproscopic Surgery under General Anaesthesia: An Academic Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritika Ranjan |
| Designation |
Post Graduate Trainee |
| Affiliation |
Asansol District Hospital |
| Address |
Asansol District Hospital
Department of Anaesthesiology
S B Gorai Road Asansol
Barddhaman
WEST BENGAL
713301
India |
| Phone |
7779821925 |
| Fax |
|
| Email |
r.ritikaranjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhab Chandra Mandal |
| Designation |
Senior Consultant, Department of Anaesthesia |
| Affiliation |
Asansol District Hospital |
| Address |
Asansol District Hospital
Department of Anaesthesiology
S B Gorai Road Asansol
Barddhaman
WEST BENGAL
713301
India |
| Phone |
|
| Fax |
|
| Email |
mcmandal80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika Ranjan |
| Designation |
Post Graduate Trainee |
| Affiliation |
Asansol District Hospital |
| Address |
Asansol District Hospital
Department of Anaesthesiology
S B Gorai Road Asansol
Barddhaman
WEST BENGAL
713301
India |
| Phone |
7779821925 |
| Fax |
|
| Email |
r.ritikaranjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Asansol District Hospital, S B Gorai Road, West Bengal-713301, India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Asansol District Hospital, S B Gorai road, West Bengal-713301, India |
| Type of Sponsor |
Other [Government District Hospital] |
|
|
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 |
| Ritika Ranjan |
Asansol District Hospital |
S B Gorai Road, Department Of Anaesthesiology. Superspeciality Building, OT complex, 4th floor.
Barddhaman
WEST BENGAL |
7779821925
r.ritikaranjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INSTITUTE OF HEALTH & FAMILY WELFARE, GOVERNMENT OF WEST BENGAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Dose:Loading dose of 1 µg/kg followed by maintenance infusion of 0.5 µg/kg/hr
Frequency: Single administration on the day of surgery.
Route of Administration: Intravenous (IV)
Total Duration: From induction of anaesthesia until the end of surgery. |
| Comparator Agent |
Magnesium Sulfate |
Dose: Loading dose of 30 mg/kg followed by maintenance infusion of 10 mg/kg/hr
Frequency: Single administration on the day of surgery
Route of Administration: Intravenous (IV)
Total Duration: From induction of anaesthesia until the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients schedule for elective laparoscopic surgery.
ASA I and II. |
|
| ExclusionCriteria |
| Details |
Patient refusal, Patients undergo emergency surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compared to magnesium sulphate, dexmedetomidine demonstrates superior efficacy in stabilizing hemodynamic parameters during pneumoperitoneum in laparoscopic procedures under general anaesthesia. |
Baseline – Before administration of study drug (after IV line placement, before induction).
After loading dose – 10 minutes after drug administration, before induction.
At intubation.
5 minutes after intubation.
At creation of pneumoperitoneum.
Every 15 minutes intraoperatively.
At extubation.
Postoperatively at 5,15, minutes in PACU (Post Anaesthesia Care Unit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Less Heart rate, Blood pressure & Mean arterial pressure variability with dexmedetomidine during critical intraoperative periods. |
Baseline – Before administration of study drug (after IV line placement, before induction).
After loading dose – 10 minutes after drug administration, before induction.
At intubation.
5 minutes after intubation.
At creation of pneumoperitoneum.
Every 15 minutes intraoperatively.
At extubation.
Postoperatively at 5,15, minutes in PACU (Post Anaesthesia Care Unit) |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
18/08/2025 |
| 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 Yet Recruiting |
| 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
|
Aim of this study is to identify the relative efficacy of Dexmedetomidine and Magnesium Sulfate on attenuation of hemodynamic responses in laparoscopic Surgery under General Anaesthesia. This study is a Double blinded Randomised controlled rial study to be conducted in the Department of Anaesthesiology at Asansol District Hospital over a period of 12 months. 102 patients were randomly allotted in 2 groups of 18-60 years, with ASA physical groups I and II posted for laparoscopic surgery under General Anaesthesia.
|