| 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
|
|
|
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
|
|
|
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. |