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CTRI Number  CTRI/2013/08/003939 [Registered on: 30/08/2013] Trial Registered Prospectively
Last Modified On: 26/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of dexmedetomidine and magnesium sulphate on propofol consumption, haemodynamics (blood pressure and heart rate) and postoperative recovery in spine surgery 
Scientific Title of Study   Comparative evaluation of dexmedetomidine and magnesium sulphate on propofol consumption, haemodynamics and postoperative recovery in spine surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No 1.0 Version No 1.0 Dated 01/08/2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinit Kumar Srivastava 
Designation  Consultant 
Affiliation  Apollo Hospitals Bilaspur 
Address  Department of Anaesthesia, Apollo Hospitals Bilaspur, Seepat Road, Lingiadih Village, Bilaspur (C.G.)

Bilaspur
CHHATTISGARH
495006
India 
Phone  9755557539  
Fax    
Email  drvinit75@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhishek Mishra 
Designation  DNB Student 
Affiliation  Apollo Hospitals Bilaspur 
Address  Department of Anaesthesia, Apollo Hospitals Bilaspur, Seepat Road, Lingiadih Village, Bilaspur (C.G.)

Bilaspur
CHHATTISGARH
495006
India 
Phone  9669980275  
Fax    
Email  abhimishraa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vinit Kumar Srivastava 
Designation  Consultant 
Affiliation  Apollo Hospitals Bilaspur 
Address  Department of Anaesthesia, Apollo Hospitals Bilaspur, Seepat Road, Lingiadih Village, Bilaspur (C.G.)

Bilaspur
CHHATTISGARH
495006
India 
Phone  9755557539  
Fax    
Email  drvinit75@gmail.com  
 
Source of Monetary or Material Support  
Apollo Hospitals Bilaspur 
 
Primary Sponsor  
Name  Apollo Hospitals Bilaspur 
Address  Seepat Road, Lingiadih village, Bilaspur (C.G.), India-495006  
Type of Sponsor  Research institution and hospital 
 
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 Vinit Kumar Srivastava  Apollo Hospitals Bilaspur  Department of Anaesthesia, 2nd Floor, Operation theatre, Apollo Hospitals Bilaspur
Bilaspur
CHHATTISGARH 		 9755557539

drvinit75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Apollo Hospitals Bilaspur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA grade I or II patient, Non diabetic, Non hypertensive and require General anesthesia with intubation ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Dexmedetomidine loading dose 1mcg/kg before induction over a period of 15 min and maintenance 0.5 mcg/kg/h throughout the surgery via intravenous (IV) route 
Intervention  Magnesium Sulphate  Magnesium sulphate loading dose 50 mg/kg before induction over a period of 15 min and maintenance 15 mg/kg/h throughout the surgery via intravenous (IV) route 
Comparator Agent  Placebo (normal saline 0.9%)  Normal saline, total volume of 20 ml before induction over a period of 15 min and maintenance 10 ml/h throughout the surgery via intravenous (IV) route 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.ASA grade I and II,
2.Non hypertensive and non diabetic
3.Scheduled for spinal surgery under general anesthesia
 
 
ExclusionCriteria 
Details  1.Known allergy to magnesium sulphate or other study drug,
2.Morbid obesity (body mass index>40),
3.Chronic use of opioids and anticoagulants
4.Current treatment with a β-blocker or calcium channel blocker
5.Diabetes and hypertension
6.Known asthma or reactive airway disease,
7.Hepatic, renal or cardiovascular dysfunction
8.Any degree of heart block
9.Haematological disorder
10.History of neuromuscular disease,
11.Patients receiving magnesium supplementation,
12.Drugs known to have a significant interaction with NMDAs
13.Psychiatric patients
14.Pregnant and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of dexmedetomidine and magnesium sulphate on propofol consumption and haemodynamics in spine surgery.  (A) Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and bispectral index (BIS) will be continuously monitored and recoreded at following time intervals
1)Preop
2)After study drug
3)After induction
4)After intubation
5)Intraop period at 20 min intervals
6)After surgery
7) After extubation

(B) Propofol requirement hourly
 
 
Secondary Outcome  
Outcome  TimePoints 
(1)Postoperative recovery parameters
- Extubation time –
- Response to verbal commands
-Time for orientation

(2)To study the adverse effects of dexmedetomidine. 		 Fentanyl and muscle relaxant requirement hourly 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/09/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Srivastava VK, Mishra A, Agrawal S, Kumar S, Sharma S, Kumar R. Comparative Evaluation of Dexmedetomidine and Magnesium Sulphate on Propofol Consumption, Haemodynamics and Postoperative Recovery in Spine Surgery: A Prospective, Randomized, Placebo Controlled, Double-blind Study. Adv Pharm Bull. 2016 Mar;6(1):75-81. doi: 10.15171/apb.2016.012. Epub 2016 Mar 17. PMID: 27123421; PMCID: PMC4845545. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Magnesium sulphate and dexmedetomidine have been used during surgery with the intention to maintain haemodynamic stability, decrease anesthetic requirement and improved postoperative recovery in general anesthesia.

Aim - To evaluate the efficacy of dexmedetomidine and magnesium sulphate on propofol consumption, haemodynamics and postoperative recovery in spine surgery.

Desigh - Prospective, randomized, placebo controlled double blinded study

Methods - Ninety patients of both gender undergoing spine surgery under general anesthesia will be randomly assigned to three groups. Group I - Dexmedetomidine loading dose 1 mcg/kg before induction over a period of 15 min and maintenance 0.5 mcg/kg/h throughout the surgery. Group II- Magnesium sulphate loading dose 50 mg/kg before induction over a period of 15 min and maintenance 15 mg/kg/h throughout the surgery. Group III - The same volume of normal saline will be administered . Anesthesia will be induced with midazolam, fentanyl, propofol and vecuronium after 5 min of loading dose of study drug. Anesthesia will be maintained with oxygen, nitrous oxide, intermittent boluses of vecuronium and fentanyl. Neuromuscular blockade will be reversed after completion of surgery. A blinded observer will be recorded haemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure and mean blood pressure) and propofol consumption. Statistical analysis will be done after completion of surgery.

 
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