FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/063248 [Registered on: 28/02/2024] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Magnesium sulphate vs Dexmedetomedine for Blood Pressure control in laparoscopic cholecystectomy. 
Scientific Title of Study   Intravenous Magnesium Sulphate versus intravenous Dexmedetomidine for the attenuation of the hemodynamic effects of pneumoperitoneum in laparoscopic cholecystectomy. 
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 Rohini Varadraj Bhat Pai 
Designation  Associate Professor 
Affiliation  Goa Medical College 
Address  Department of Anesthesiology Goa Medical College Bambolim

North Goa
GOA
403202
India 
Phone  7741866436  
Fax    
Email  docpai@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rohini Varadraj Bhat Pai 
Designation  Associate Professor 
Affiliation  Goa Medical College 
Address  Department of Anesthesiology Goa Medical College Bambolim

North Goa
GOA
403202
India 
Phone  7741866436  
Fax    
Email  docpai@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rohini Varadraj Bhat Pai 
Designation  Associate Professor 
Affiliation  Goa Medical College 
Address  Department of Anesthesiology Goa Medical College Bambolim

North Goa
GOA
403202
India 
Phone  7741866436  
Fax    
Email  docpai@rediffmail.com  
 
Source of Monetary or Material Support  
Goa Medical College 
 
Primary Sponsor  
Name  Goa Medical College 
Address  Goa Medical College Bambolim Goa 403202 
Type of Sponsor  Government medical college 
 
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 Abhinandan Chougale  Goa Medical College  Lower Operation Theatre Goa Medical College Bambolim
North Goa
GOA 
8123979577

chougaleabhinandan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GOA MEDICAL COLLEGE INSTITUITIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: K808||Other cholelithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group D  Dexmedetomidine 1μg/kg in 100 ml normal saline over 10 minutes Group D will receive dexmedetomidine maintenance infusion at rate of 0.5 μg/kg/hr 
Intervention  Group M  Magnesium sulphate 40 mg/kg or a maximum dose of 2 g in 100 mL over 10 min. Group M will receive magnesium sulphate infusion at rate of 15 μg/kg/hr. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)ASA class I or II assigned for laparoscopic cholecystectomy 
 
ExclusionCriteria 
Details  1)difficult airway
2)body mass index ( BMI) > 35 kg/m2
3) pre-existing disease affecting the neuromuscular junction or muscles, seizure disorder, cardiac, diseases, renal or liver impairment, hypermagnesaemia, acute cholecystitis 4)allergy to any of the used drugs
5) patients in whom laparoscopic approach is changed to open approach  
 
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 
hemodyanamic stabilty  Premedication / any infusion
Post intubation
5 min
10 min
During pneumoperiteum
5 min after
15 min
30 min
60 min
90 min
120 min
150 min
180 min
210 min
Pre extubation
Post extubation
 
 
Secondary Outcome  
Outcome  TimePoints 
1)INTRAOP NO. OF MUSCLE RELAXANTS TOPUPS
2)TIME TAKEN TO EXPERIENCE PAIN
3)SIGNIFICANT INTRAOP EVENTS
 
Premedication / any infusion
Post intubation
5 min
10 min
During pneumoperiteum
5 min after
15 min
30 min
60 min
90 min
120 min
150 min
180 min
210 min
Pre extubation
Post extubation
POSTOPERATIVE
0 min
10 min
30 min (shiftout)

 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/04/2024 
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="0"
Months="6"
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  

We aim to study  the effect  of intravenous dexmedetomidine and intravenous magnesium sulphate infusions on haemodynamic profile ,  sedation score  and duration of post operative analgesia in patients undergoing  laparoscopic cholecystectomy. 

Patients will be randomly allocated into 2 groups using sealed envelope technique based on a computer generated random number table  which will be as follows: Group D will receive dexmedetomidine infusion and group M will receive intravenous infusion of magnesium sulphate.

After securing a wide bore intravenous cannula and  initiating standard ASA monitoring ( electrocardiography, non invasive blood pressure monitoring, pulse oximetry)  the baseline data (T0) including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), and heart rate (HR) will be  monitored and recorded . Ringer Lactate will be started at the rate of 10ml/kg/hour. The  patients will be premedicated with midazolam 0.05 mg/kg, intravenous fentanyl 2 μg/kg, intravenous glycopyrrolate 0.01mg/kg and intravenous ondansetron 0.1 mg/kg . The study drugs will be given as follows:

Group D: Dexmedetomidine 1μg/kg  in 100 ml  normal saline over 10 minutes

 Group M: Magnesium sulphate  40 mg/kg  or a maximum dose of 2 g in 100 mL over 10 min.

Induction will be done using propofol 2 mg/kg followed by atracurium (0.5mg/kg) to facilitate tracheal intubation. Tracheal intubation will be done by an experienced  anaesthesia personnel . It will be performed after TOF is 0 with a 7.0  mm and  8.0 mm internal diameter (ID) endotracheal tube in female and male patients respectively.

Group D will receive  dexmedetomidine maintenance infusion at rate of 0.5 μg/kg/hr and  Group M will receive magnesium sulphate infusion at rate of 15 μg/kg/hr.

 The pneumoperitoneum will be performed using non-humidified and non-heated CO2, with the intra-abdominal pressure maintained around 10 -14 mmHg.

 Patients will be ventilated to maintain normocapnia.  All patients will receive fentanyl  1  μg/kg hourly and the muscle relaxant top up will be given when the TOF ratio is1/ 4 or more.The sevoflurane will be maintained at 4% with oxygen in air 1:1 . If the pulse rate or systolic blood pressure or mean arterial pressure increase to more than 20% baseline values then an additional dose of fentanyl 1 μg/kg will be administered. The total fentanyl and atracurium consumed will be recorded. The sevoflurane consumption rate  will be calculated as per the following formula :

Ml of liquid anaesthetic /hour = 3.3 X dial concentration ( V/V%) X fresh gas flow ( litres /min)

Port site local infiltration with 10 ml 0.25% bupivacaine will be given at the end of surgery.

Heart rate (HR), systolic blood pressure (SBP) and mean arterial blood pressure (MAP) will be recorded at baseline before loading dose; after anaesthetic induction, immediately post intubation, during and after 5 minutes of pneumoperitoneum insufflation and then at 15, 30, 60, 90, 120 min (every half hourly till surgery end); and postoperatively at end of surgery, post-extubation, and at 10 and 30 min after extubation.

The sevoflurane will be stopped just after the last suture. The time for extubation from stopping the sevoflurane to removal of the ETT will be recorded. 

The sedation score will be assessed according to the Ramsay Sedation Score immediately postoperatively and at 10 and 30 minutes in the PACU.

The pain score will be assessed as per the Visual Analogue Scale (VAS) on a scale of 0-10 till the VAS is 4 or more than 4. Intravenous paracetamol 1 gram and additional dose of fentanyl (if needed) will be given as rescue analgesics.

All intraoperative and postoperative complications will be recorded.

Categorical variables will be analyzed using chi-square  test. Continuous variables will be analyzed using unpaired Student’s t-test or univariate two-group repeated measures “mixed-design” analysis of variance (ANOVA) with post hoc Dunnett’s test as appropriate. Nominal and nonnormally distributed variables will be analyzed using Mann-Whitney U test.

A p value < 0.05 will be considered as significant. Statistical analyses will be performed by computerized statistical software (SPSS, version 21; SPSS, Chicago, Ill).

 
Close