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CTRI Number  CTRI/2022/09/045193 [Registered on: 02/09/2022] Trial Registered Prospectively
Last Modified On: 31/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of Intravenous Midazolam and Dexmedetomidine when given before operation in Laproscopic cholecystectomy with CNS monitoring with Propofol for induction of Anaesthesia. 
Scientific Title of Study   comparison of intravenous midazolam and dexmedetomidine as premedication in laproscopic cholecystectomy in bispectral index guided propofol induction of anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Habiba Atif 
Designation  Pg 1st year Anaesthesia 
Affiliation  School of Medical Sciences and Research ,Sharda University 
Address  Department of Anaesthesiology , School of Medical Sciences and Research, Plot no.32,34, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8127472129  
Fax    
Email  atif.habiba@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manish Kumar Agarwal 
Designation  Associate Professor 
Affiliation  School of Medical Sciences and Research ,Sharda University 
Address  Department of Anaesthesiology , school of medical sciences and research ,plot no.32,34 , knowledge park 3 , greater noida , gautam buddha nagar

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9838706199  
Fax    
Email  dr.manishagarwal09@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Habiba Atif 
Designation  Pg 1st year Anaesthesia 
Affiliation  School of Medical Sciences and Research ,Sharda University 
Address  Department of Anaesthesiology , school of medical sciences and research ,plot no.32,34 , knowledge park 3 , greater noida , gautam buddha nagar

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8127472129  
Fax    
Email  atif.habiba@gmail.com  
 
Source of Monetary or Material Support  
School of Medical Sciences and Research , Sharda University 
 
Primary Sponsor  
Name  Sharda Hospital 
Address  Plot no. 32,34 ,knowledge park 3, greater noida 
Type of Sponsor  Private 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 habiba Atif  Sharda Hospital , school of medical sciences and research  Department of Anaesthesiology , 2nd floor , B block , sharda hospital , greater noida
Gautam Buddha Nagar
UTTAR PRADESH 
8127472129

atif.habiba@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine  once the patient consents they will be allocated to a group and inj dexmedetomidine 1.5ug/kg diluted to make a volume of 5 ml ,injected 20 mins prior to surgery then standard anaesthesia will be given with infusion propofol 30mg/kg /h until BIS is stabilized at 48+/- 2 and remained stable for that. once the desired BIS value is reached propofol infusion will be switched and total dose of propofol will be noted. 
Comparator Agent  midazolam  once the patient consents they will be allocated to a group and inj midazolam 50 ug/kg diluted to make a volume of 5 ml ,injected 20 mins prior to surgery then standard anaesthesia will be given with infusion propofol 30mg/kg /h until BIS is stabilized at 48+/- 2 and remained stable for that. once the desired BIS value is reached propofol infusion will be switched and total dose of propofol will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient scheduled for elective laproscopic cholecystectomy
2. age 18-60 years
3. both genders
4. ASA grade 1 and 2 
 
ExclusionCriteria 
Details  1. Patients refusal to participate in study
2. Morbid obesity BMI >30
3. History of sleep apnoea
4. Pharmacological therapy - Benzodiazipines, opoids , antipsychotics
5. anticipated difficult intubation
6. Sinus bradycardia or bundle branch block on ECG
7. Pregnant females
8. coagulopathy or bleeding diathesis
9. history of hypertension , diabetes mellitus, thyroid disease.
10. history of CNS , cardiovascular and renal diesease 
 
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 
To compare the induction dose of propofol , in the three groups , midazolam , dexmedetomidine and the control group  We will monitor Heart Rate, Blood Pressure, Oxygen saturation ,Bispectral Index Value at -
Preoperative period
Preinduction period
Preintubation .
At The Time of intubation.
Post intubation every minute till 10 minutes then
every 10 minute till the end of surgery
then we will monitor the outcome with modified Aldrete score post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the haemodynamic changes between different groups during intubation.
2. To compare the recovery profile between different groups.
3. To observe the post anaesthetic complications if any. 
1 hour 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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   N/A 
Date of First Enrollment (India)   10/09/2022 
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="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet Published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 

Surgery and anaesthesia is a stressful condition and are associated with stimulation of neuroendocrinal pathway, producing various hemodynamic effects, which may be harmful for the patient. Methods to decrease these effects include maintaining an adequate depth of anaesthesia to prevent these hemodynamic effects, or to give some pharmacological preparation to the patients, which will modify the response of anaesthetic drugs

 

Premedication is a part of pre-anaesthesia preparation which aims to prepare patients both physically and mentally for anaesthetic procedures. The main goal of pre-treatment is to eliminate anxiety. There are several classes of drugs used for the purposes of premedication, including sedatives, alpha-2 adrenergic agonists, anticholinergics, narcotics, antihistamines, antacids, and H2 antagonists 

 

Included in the sedative group are barbiturates, benzodiazepines, and butyrophenones. Midazolam belongs to benzodiazepine group, which is water soluble. It is short acting, widely used as an anxiolytic, sedative, and anaesthetic adjuvant, and has numerous advantages, such as a short elimination half-life, a significant anterograde amnesia, mild respiratory depression, and a relief of anxiety 

 

Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist and possesses the potential benefit of sedation, sympatholysis, analgesia, and cardiovascular stability, Its hemodynamic effects are predictable and dose dependent. Dexmeditomidine, at clinically effective dosages, does not depress respiration, and therefore does not interfere with extubation 

 

Laparoscopic surgery is a modern surgical technique involving insufflation of gas (usually CO2) into the peritoneal cavity under pressure to separate organs from abdominal cavity. Laparoscopic cholecystectomy has revolutionized gall bladder surgeries and it has now become the gold standard for the treatment cholelithiasis 

 
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