| CTRI Number |
CTRI/2024/02/062251 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effectiveness of Magnesium Sulfate and Dexmedetomidine in attenuating the stress response to pneumoperitoneum in Laparoscopic Cholecystectomy surgeries under General Anaesthesia |
|
Scientific Title of Study
|
Comparison of the efficacy of Magnesium Sulfate and Dexmedetomedine for attenuation of hemodynamic stress response to pneumoperitoneum in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia. |
| 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. Sesham Sonu |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Kadapa |
| Address |
Department Of Anaesthesiology
Government Medical College
Kadapa
Cuddapah
ANDHRA PRADESH
561002
India |
| Phone |
9966844503 |
| Fax |
|
| Email |
drsonu818@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sesham Sonu |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Kadapa |
| Address |
Department Of Anaesthesiology
Government Medical College
Kadapa
Cuddapah
ANDHRA PRADESH
561002
India |
| Phone |
9966844503 |
| Fax |
|
| Email |
drsonu818@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annamalai Ramamoorthy |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Kadapa |
| Address |
Department Of Anaesthesiology
Government Medical College
Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8531851625 |
| Fax |
|
| Email |
aadhavan502@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Government Medical College
kadapa
Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Sesham Sonu |
| Address |
Assistant Professor,
Department of Anaesthesioogy,
Government Medical College
kadapa
Andhra Pradesh |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Sesham Sonu |
Government Medical College |
Room No. 200
IP Block,
Department of Anaesthesiology,
Government Medical College,
Kadapa.
Cuddapah
ANDHRA PRADESH |
9966844503
drsonu818@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee,Government Medical College, Kadapa |
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 |
| Comparator Agent |
compare stress response to pneumo-peritoneum |
compare heart rate and mean arterial pressure between two groups before and after induction, before peritoneal insufflation, 5, 15,30 min after peritoneal insufflation, 5 min after peritoneal deflation |
| Intervention |
Dexmedetomidine
Magnesium sulfate |
Dexmedetomedine 1mcg/kg IV in 100ml Normal saline 15 min before induction followed by 0.2mcg/kg/hr upto peritoneal deflation.
Magnesium sulfate 40mg/kg IV in 100ml Normal saline 15 min before induction followed by 10mg/kg/hr upto peritoneal deflation. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists Physical Status 1 and 2
posted for elective laparoscopic cholecystectomy under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with known cardiac abnormalities, Uncontrolled hypertension & diabetes mellitus, Pregnancy, Morbidly obese, History of allergy to any of the study drugs |
|
|
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 |
| Stress Response to pneumoperitoneum as measured by increase in Heart Rate and Mean Arterial Blood Pressure |
Baseline, 5 minutes, 15 minutes, 30 minutes and 60 minutes after peritoneal insufflation with CO2, 5 minutes after peritoneal deflation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse effects |
intraoperative and post operative periods |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
INTRODUCTION
Laparoscopic
cholecystectomy is gaining popularity as it is cost-effective and has minimal
blood loss due to small incision, early ambulation and recovery compared to
conventional open procedure. The pneumoperitoneum is produced by administering
CO2 in the peritoneal cavity which affects cardiovascular and pulmonary physiology
and causes stress response.
AIMS AND OBJECTIVE:
The study’s primary objective is to compare hemodynamics (mean arterial pressure -
MAP and Heart Rate - HR) between two groups. The secondary objective is to compare the adverse effects between the two groups.
MATERIALS AND METHODS: Approval of the institutional ethical committee is obtained. A total
number of 60 patients aged between 30-60 years of either gender, belonging to
ASA status I, and II posted for elective laparoscopic cholecystectomy surgeries
will be randomly allocated into two equal groups using the computer-generated random
list.
EXCLUSION CRITERIA -Patients
with known cardiac abnormalities, Uncontrolled hypertension & diabetes mellitus, Pregnancy, Morbidly obese, History of allergy
to any of the study drugs.
Group D will receive Dexmedetomidine 1µg/kg in 100ml
saline over 15 mins IV before induction, followed by 0.2µ/kg/hr.
GroupM will receive Magnesium sulfate 40mg/kg IV in 100ml saline over
15mins before induction followed by 10 mg/kg/hr.
Intraoperative
hemodynamic parameters like heart rate and mean arterial blood pressure(MAP) will be monitored.Baseline parameters (P0,)
Before intubation(P1), After intubation(P2), Before peritoneal insufflation(P3),
5mins after peritoneal insufflation(P4), 15 mins after peritoneal
insufflation(P5), 30mins after peritoneal insufflation(P6). 60 mins after peritoneal
insufflation(P7), 5 mins after peritoneal deflation(P8),After
extubation(P9),After patient shifted to PACU(P10). |