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
|
|
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
|
|
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 |