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CTRI Number  CTRI/2018/03/012744 [Registered on: 22/03/2018] Trial Registered Retrospectively
Last Modified On: 14/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of addition of different drugs before layngoscopy and intubation to prevent rise in BP and heart rate in patients undergoing general anaesthesia 
Scientific Title of Study   A study to compare the Pressor Responses to Laryngoscopy and Endotracheal Intubation with intravenous Dexmedetomidine vs Magnesium sulphate as premedicants in surgical patients under BIS monitored General 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 Ruchi Gupta 
Designation  Professor and Head, Department of Anaesthesia, SGRDIMSR 
Affiliation  SGRDIMSR 
Address  Department of anaesthesia and critical care, Sri Guru Ram Das Institute of Medical Sciences and Research, Vallah, Sri Amritsar Punjab 143501 India

Amritsar
PUNJAB
143501
India 
Phone  9814320805  
Fax    
Email  drruchisgrd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjot Kaur 
Designation  Junior Resident 
Affiliation  SGRDIMSR 
Address  Department of anaesthesia and critical care, Sri Guru Ram Das Institute of Medical Sciences and Research, Vallah, Sri Amritsar Punjab 143501 India
Department of anaesthesia and critical care, Sri Guru Ram Das Institute of Medical Sciences and Research, Vallah, Sri Amritsar Punjab 143501 India
Amritsar
PUNJAB
143501
India 
Phone  9478706278  
Fax    
Email  manjotkaur1417@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kuljit Singh Aujla 
Designation  Professor 
Affiliation  SGRDIMSR 
Address  Department of anaesthesia and critical care, Sri Guru Ram Das Institute of Medical Sciences and Research, Vallah, Sri Amritsar Punjab 143501 India

Amritsar
PUNJAB
143501
India 
Phone  9814420438  
Fax    
Email  drkuljitsinghaujla@gmail.com  
 
Source of Monetary or Material Support  
Sri Guru Ram Das Institute of Medical Sciences and Research, Vallah, Amritsar, Punjab 
 
Primary Sponsor  
Name  SGRDIMSR 
Address  Sri Guru Ram Das Institute of Medical Sciences & Research, Vallah, Amritsar, Punjab 
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 Ruchi Gupta  SGRDIMSR, Amritsar  Operation Theatre Complex, First Floor, Wing B Department Of Anaesthesia
Amritsar
PUNJAB 
9814320805

drruchisgrd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  General Surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous premedication with dexmedetomidine and magnesium suphate  To study blunting of pressor response under BIS monitoring 
Comparator Agent  Slow intravenous injection of 1 ug/kg dexmedetomidine and 30 mg/kg magnesium sulphate in 100 ml normal saline as adjuvants 15-20 minutes prior to induction of general anaesthesia  To evaluate the changes in heart rate, blood pressure, mean arterial pressure and ECG in response to laryngoscopy & intubation before study drug, after study drug, at induction every 1 minute till 5 minutes, then every 2 minutes till 10 minutes and every 10 minutes thereafter in patients undergoing elective surgery under BIS monitored general anaesthesia. To study & compare the effect on heart rate, blood pressure, mean arterial pressure and ECG of i.v. dexmedetomidine 1µg/kg and i.v. magnesium sulphate 30 mg/kg. To evaluate incidence of side effects & perioperative complications.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I and II
Scheduled for elective surgery under GA
 
 
ExclusionCriteria 
Details  1. ASA III and above
2. Major hepatic, renal or cardiovascular dysfunction
3. Pregnancy, PIH
4. Patients on anticoagulation therapy
5. Postural hypotension
6. Anticipated difficult airway
7. Uncontrolled hypertension and myocardial disease
8. Surgeries involving anticipated major blood losses and fluid shifts
9. Patients on sedatives other than used for study
10. Patients with drug allergies
 
 
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 
Attenuation haemodynamic stress response to laryngoscopy and intubation  15 minutes after study drug infusion till 30 minutes post-intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Propofol and muscle relaxant sparing effect of dexmedetomidine and magnesium sulphate, respectively  15 minutes after study drug infusion till whole of intraoperative period 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/01/2016 
Date of Study Completion (India) 24/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After taking an approval from hospital ethics committee and a written informed consent, 120 patients in the age group of 18-60 years of either sex, ASA grade I and II were allocated into three groups of 40 patients each in a randomized double blind manner with every patient receiving 100 ml of test drug solution via intravenous route as follows:

Group I (n=40): Dexmedetomidine 1 µg/kg in normal saline making a total of 100ml

Group II (n=40): Magnesium sulphate 30mg/kg in normal saline making a total of 100ml

Group III (n=40): Normal saline to a total of 100ml

            The results were compiled and compared statistically in terms of demographics, duration of surgery, sedation scores, BIS values, hemodynamic parameters- heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and ECG changes and any adverse effects. All the groups were comparable in terms of age, sex and ASA status. Dose of propofol required for intubation and the dose of vecuronium required intraoperatively were also recorded.

To summarize-

1.    Lower BIS levels themselves facilitated smooth tracheal intubation without any pressor responses as seen in placebo group.

2.    Use of both dexmedetomidine and magnesium sulphate may prove beneficial in the anaesthesia settings where BIS monitoring facilities are lacking, due to their BP & HR lowering properties.

3.    However, both the adjuvants i.e. dexmedetomidine and magnesium sulphate reduced the time to reach BIS 40-60 by producing sedative effects, but Ramsay Sedation Scores were comparatively higher in dexmedetomidine group.

4.    Sparing of propofol was exceptionally more in dexmedetomidine treated study population.

5.    MgSO4 although caused less propofol sparing effect but had an additional vecuronium sparing effect.

6.    In balanced anaesthesia, titration of propofol and other anaesthetic agents guided by BIS index, decreases the incidence of intraoperative awareness, decreases the dose of propofol and significantly improves the recovery.

7.    Use of BIS monitoring as an objective marker for assessing the level of consciousness and as a guide to determine end points of anaesthetic requirements, can prevent the over-infusion or under-dosage of anesthetic drugs. 

 

 
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