| CTRI Number |
CTRI/2024/10/074669 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Magnesium Sulphate and Dexmedetomidine for Attenuating Pressor Responses During Pneumoperitoneum in Laparoscopic Surgery: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Attenuation of pressor response to pneumoperitoneum in laparoscopic surgeries, comparison between magnesium sulphate and dexmedetomidine.A randomized control study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ratan A Nalatwadmath |
| Designation |
JR 2 |
| Affiliation |
Shri devaraj urs medical college |
| Address |
Department of anaesthesia,
Shri deveraj urs medical college, Tamaka, Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9449548789 |
| Fax |
|
| Email |
ratan.n.2726@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kiran N |
| Designation |
professor |
| Affiliation |
Shri devaraj urs medical college |
| Address |
Professor,
department of anaesthesia
Shri deveraj urs medical college, Tamaka, Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9740468460 |
| Fax |
|
| Email |
Dr.nkiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ratan A Nalatwadmath |
| Designation |
JR 2 |
| Affiliation |
Shri devaraj urs medical college |
| Address |
Department of anaesthesia,
Shri deveraj urs medical college, Tamaka, Kolar
KARNATAKA
563103
India |
| Phone |
9449548789 |
| Fax |
|
| Email |
ratan.n.2726@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri devaraj urs academy of higher education and research,Tamaka, KOlar, Karanataka, India
563103 |
|
|
Primary Sponsor
|
| Name |
Shri devaraj urs medical college |
| Address |
Shri devaraj urs medical college, Tamaka, Kolar
563103 |
| 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 |
| Dr Ratan A Nalatwadmath |
Shri devaraj urs medical college |
Department of anaesthesia, Shri devaraj urs medical college, Tamaka, Kolar 563103
Kolar
KARNATAKA |
9449548789
ratan.n.2726@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri devraj urs medical college |
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 |
comparison between Magnesium sulfate vs dexmedetomidine for Pressor response in laparoscopic surgery |
Group A: Infusion of 50mg/kg of MgSo4 in 100 ml Normal Saline over 20 minutes prior to induction of Anaesthesia
Group B: Infusion of 1 mcg/kg of Dexmedetomidine in 100 ml Normal Saline over 20 minutes prior to induction of Anaesthesia |
| Intervention |
Magnesium sulfate vs. dexmedetomidine for Pressor response in laparoscopic surgery |
Group A: Infusion of 50mg/kg of MgSo4 in 100 ml Normal Saline over 20 minutes prior to induction of Anaesthesia
Group B: Infusion of 1 mcg/kg of Dexmedetomidine in 100 ml Normal Saline over 20 minutes prior to induction of Anaesthesia
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients undergoing laparoscopic surgeries under general anaesthesia.
2 ASA 1 and 2
|
|
| ExclusionCriteria |
| Details |
1 Patients with abnormal ECG, difficult airway
2 Patients with pre existing disease effecting NMJ
3 Patients with pre existing cardiac, renal, hepatic, cerebral diseases
4 Patients with seizure disorder, electrolyte abnormality
5 Patients with psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stastical analysis of the data will be performed using SPSS 20.0, descriptive statistics of SBP,DBP, MBP,and HR will be expressed using mean ± SD. Catagorical variables will be expressed as frequency and percentage. Pre and Post comparison within group will be done using Paired T test. Between the group comparison in all the parameters will be done using unpaired t test . A value 0.05 will be considered statistically significant. |
systolic blood pressure, diastolic blood pressure, mean blood pressure and heart rate are be documented at baseline, 1st min, 5th min, 10th min, 30th mins, 60th min, and at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare which drug is better suitable for laparoscopic surgeries. |
by measuring hemodynamic parameters at time intervals at baseline,1st min,5th min, 10th min, 30 mins, 60 mins |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 2 |
|
Date of First Enrollment (India)
|
14/10/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized controlled trial designed to compare the effectiveness of magnesium sulfate and dexmedetomidine in reducing the pressor response (elevated blood pressure and heart rate) that occurs during pneumoperitoneum in laparoscopic surgeries. The trial aims to determine which of these two interventions better mitigates the cardiovascular changes associated with the insufflation of gas into the abdominal cavity. Participants undergoing laparoscopic procedures will be randomly assigned to receive either magnesium sulfate or dexmedetomidine, and their pressor responses will be measured and compared to identify the more effective treatment. |