FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075661 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 21/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dexmedetomidine vs Magnesium sulfate in blood pressure and heart rate control in patients undergoing laparoscopic surgery for gall bladder removal 
Scientific Title of Study   Effect of Magnesium sulfate and Dexmedetomidine on hemodynamic perturbations,anesthetic requirements and recovery profile in adult patients undergoing Laparoscopic cholecystectomy-A prospective double blind randomized 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  Dr Neha Basheer P 
Designation  Junior Resident 
Affiliation  All India Institute Of Medical Sciences,Bhopal 
Address  Department of Anesthesia and critical care,3rd floor hospital building,AIIMS Bhopal,Saket Nagar Bhopal Madhya Pradesh 462020 India
Rani laxmibai ladies hostel,pg, aiims bhopal Bhopal Madhya Pradesh 462020 India
Bhopal
MADHYA PRADESH
462020
India 
Phone  9061334787  
Fax    
Email  nehabasheerp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S R A N Bhushanam Padala 
Designation  Assistant Professor 
Affiliation  All India Institute Of Medical Science,Bhopal 
Address  Department of Anesthesia and critical care,3rd floor hospital building,AIIMS Bhopal,Saket Nagar Bhopal Madhya Pradesh 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S R A N Bhushanam Padala 
Designation  Assistant Professor 
Affiliation  All India Institute Of Medical Science,Bhopal 
Address  Department of Anesthesia and critical care,3rd floor hospital building,AIIMS Bhopal,Saket Nagar Bhopal Madhya Pradesh 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala72@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences Bhopal(Non funded) Saket Nagar, Bhopal, Madhya Pradesh, India Pincode 462020  
 
Primary Sponsor  
Name  Dr S R A N Bhushanam Padala 
Address  Department of Anesthesiology and Critical Care AIIMS Bhopal Saket Nagar, Bhopal, Madhya Pradesh, India Pincode 462020  
Type of Sponsor  Other [Guide(Assistant Professor)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neha Basheer P  AIIMS Bhopal  Department of Anesthesology and Critical Care 3rd floor and Department of General Surgery 2nd floor,Hospital building AIIMS Saket Nagar,Bhopal Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH 
9061334787

nehabasheerp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhopal Instittutional Human Ethics Committee-Student Research(IHEC-SR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous Dexmedetomidine  Group D-Dexmedetomidine 1ml(200microgram) and 19 ml 0.9% normal saline(10microgram dexmedetomidine/1ml)given as o.4ml/kg/hr for 15 minutes as bolus followed by 0.03ml/kg/hr infusion 
Intervention  Intravenous Magnesium Sulfate  Group M-Magnesium sulfate 12ml(6000mg) and 8ml 0.9% normal saline(300mg/1ml) given as 0.4ml/kg/hr for 15 minutes as bolus followed by 0.03ml/kg/hr infusion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age:18-65 years
2.ASA Physical status 1 and 2 
 
ExclusionCriteria 
Details  1.Patients with hypermagnesemia
2.Patients with heart blocks or arrythmias
3.Patients allergic to study drugs and addicted to narcotics
4.Patients with chronic liver/renal/cardiovascular diseases
5.Patients who are on beta blockers
6.Surgeries which lasts for more than 4 hours
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of Magnesium sulfate and Dexmedetomidine on hemodynamic perturbations following pneumoperitoneum during laparoscopic cholecystectomy  T4-Before pneumoperitoneum
T5-1 min after pneumoperitoneum
T6-5 min after pneumoperitoneum
T7-15 min after pneumoperitoneum
T8-30 min after pneumoperitoneum
T9-After release of pneumperitoneum 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of magnesium sulfate and dexmedetomidine on hemodynamic perturbations following laryngoscopy and intubation  T0-Base line
T1-Before induction
T2-1 min after intubation
T3-5 min after intubation 
To compare the effect of study drugs on intraoperative anesthetic requirement(propofol and fentanyl)  Throughout intraoperative period 
To compare the effect of study drugs on postoperative recovery profile (extubation,eye opening and recovery times and NRS  T10-1 min after extubation
T11-15 min after extubation
T12-60 min after extubation
Extubation time
Eye opening time
Recovery time
NRS score-15 min post extubation
NRS score-60 min post extubation 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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 4 
Date of First Enrollment (India)   28/10/2024 
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="6"
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  

Laparoscopic surgery is one of the most essential diagnostic and therapeutic techniques in today’s surgical world.It has become the gold standard surgery for cholelithiasis. Philippe Mouret performed the first successful cholecystectomy in 1987. Laparoscopic cholecystectomy has numerous advantages over conventional cholecystectomy.This includes decreased tissue trauma, shorter hospital stay, earlier ambulation, a smaller scar, and less compromised postoperative respiratory and GI systems.However, there are significant hazards linked with it also. In laparoscopic cholecystectomy procedures, CO2 is used to produce pneumoperitoneum mostly.There is a risk of significant hemodynamic changes during laparoscopic cholecystectomy due to laryngoscopy, endotracheal intubation, the creation of pneumoperitoneum, systemic absorption of co2, and the steep head-up (reverse Trendelenburg) position, which is characterized by an abrupt increase in arterial pressure, systemic vascular resistance, and decreased cardiac output.This will create a difficult circumstance for a practicing anesthesiologist. Adequate regulation of the sympathetic response is required to reduce perioperative morbidity and improve patient outcomes.The goal of anesthetic management in laparoscopic procedures is to reduce pneumperitoneum-induced hemodynamic responses while also providing acceptable depth and pain control, with the ultimate goal of minimizing stress response and allowing for early discharge. For these reasons, general anesthesia with tracheal intubation is the preferred anesthetic approach. Like laryngoscopy, the pneumoperitoneum response is mediated by sympathetic overactivity.Many medications, including opioids, vasodilators, beta blockers, nitroglycerin, and midazolam, have been tested throughout the years to suppress the sympathetic response specific to laparoscopic procedures.They all have different levels of advantages and downsides.Previous randomised control trials using dexmedetomidine and magnesium sulfate have yielded excellent results at varying doses. Dexmedetomidine, the active dextro isomer of medetomidine, is a highly selective alpha 2 adrenoreceptor agonist when compared to the alpha 1 receptor (1620:1).This may result in higher  sedative effects while avoiding the negative cardiovascular effects associated with alpha 1 receptor stimulation.It possesses effective analgesic, sedative, hypnotic, anxiolytic, and sympatholytic properties without causing severe respiratory depression. It is used for icu sedation, procedural sedation (awake fibreoptic intubation, colonoscopy, bronchoscopy, and so on), premedication, as a supplement to general anesthesia, intrathecally, and regionally.It can also be utilized to keep hemodynamics stable during a laparoscopic cholecystectomy.The stimulation of alpha2 receptors in the locus ceruleus of the pons lowers central sympathetic output while increasing inhibitory neuronal activity.It accomplishes this by blocking the release of catecholamines.Dexmedetomidine is administered intravenously and produces effects in <5 minutes, peak in 15 minutes. The duration is around 60-120 minutes. Magnesium is essential for a variety of physiological functions.Among the various actions of magnesium, blocking the N-methyl-D-aspartate (NMDA) receptor and calcium channel plays a significant role in anesthesia.The normal range for magnesium in plasma is 0.7-1.1 mmol/L (1.4-2.2 mEq/L). Magnesium sulphate delivered IV would also be effective in reducing unfavorable hemodynamic reactions since magnesium has the potential to block catecholamine production from both the adrenal gland and the adrenergic nerve terminal.It also acts on blood vessels in order to dilate them and reduce vasopressin-mediated constriction, and has direct myocardial depressant actions . The present study was undertaken with the objective of comparing the effectiveness of dexmedetomidine (10mcg/ml ,0.1ml/kg for 15 min followed by 0.03ml/kg/hr infusion)on hemodynamic perturbations ,anesthetic requirements and recovery profile in adult patients undergoing laparoscopic cholecystectomy with that of magnesium sulfate(300mg/ml,0.1ml/kg for 15 min followed by 0.03ml/kg/hr infusion). Many studies have been conducted with varying doses of dexmedetomidine to find it’s effectiveness in reducing hemodynamic stress responses in laparoscopic cholecystectomy as well as other surgeries. But magnesium sulfate is a less explored drug in this regard.To the best of our knowledge there are not any published article comparing dexmedetomidine and magnesium sulfate infusions for reducing hemodynamic prturbations in laparoscopic cholecystectomy. 

 

 
Close