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CTRI Number  CTRI/2024/07/069883 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 30/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Controlled hypotension in spine surgeries 
Scientific Title of Study   The effect of Dexmedetomidine vs Magnesium sulphate for controlled hypotension in Spine surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ishita Gupta 
Designation  PG Student  
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Anaesthesiology Kasturba Medical College Light House hill road Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8447150240  
Fax    
Email  ishita1.kmcmlr2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumesh T Rao 
Designation  Professor and Head of Department  
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Anaesthesiology Kasturba Medical College Light House hill road Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449167895  
Fax    
Email  sumesh.rao@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Sumesh T Rao 
Designation  Professor and Head of Department  
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Anaesthesiology Kasturba Medical College Light House hill road Mangalore


KARNATAKA
575001
India 
Phone  9449167895  
Fax    
Email  sumesh.rao@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College Lighthouse hill road Mangalore 575001 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Lighthouse hill road Mangalore 575001 
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 Ishita Gupta  Kasturba Medical college Hospital  Department of Anaesthesiology Kasturba medical college Lighthouse hill road Mangalore
Dakshina Kannada
KARNATAKA 
8447150240

ishita1.kmcmlr2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba medical college, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine (Group D)  Loading dose: In Group D, patients will be administered 1μg/kg (intravenous) dexmedetomidine in 100 mL saline solution 10 min before surgery. Maintainence dose:In Group D, 0.5-1 μg/kg/h (intravenous) dexmedetomidine will be administered during surgery. The maintenance dose will be given till the surgeon starts to close the surgery Total duration: 6 months The surgical team will be blinded to group allocation.  
Comparator Agent  Magnesium sulphate (Group M)  Loading dose: In Group M, patients will be administered 40 mg/kg magnesium sulfate(intravenously) in 100 mL saline solution 10 min before surgery. Maintainence dose: In group M, 10-15 μg/kg/h (intravenously) magnesium sulphate will be given during surgery. The maintenance dose of these drugs will be given till the surgeon starts to close the surgery Total duration: 6 months The surgical team will be blinded to group allocation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Scheduled for spine surgery eg: Microdisectomy, fractures, disc herniation, decompression surgeries etc (limited to 4-6 hours)
2. American Society of Anesthesiologists (ASA) physical status I-II.
3.18 to 65 years of age
 
 
ExclusionCriteria 
Details  1.Known allergy to dexmedetomidine or magnesium sulfate
2.History of uncontrolled cardiovascular disease
3.History of neurological disease
4.Severe renal impairment
5.Hepatic disease
6.Coagulopathy
7.Patient refusal
8.hypotension is not achieved by these drugs with in 30min intraoperatively
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean Arterial Pressure   1.Basline vitals
2.Every 15minutes till the surgery is over 
 
Secondary Outcome  
Outcome  TimePoints 
1.Surgical site visibility
2.Total blood loss
3.Surgeons’ satisfaction
4.Adverse effects 
1. Surgical field bleeding will be evaluated every 15minutes
2. At the end of surgery the comparison of total blood loss
and the surgeons satisfaction on the field visibility  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/07/2024 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sumesh.rao@manipal.edu].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Controlled hypotension is a technique to reduce blood loss and the need for blood transfusion during surgery by improving the visibility of surgical site and decreasing the blood pressure until hypotension is achieved. Nowadays, newer and more sensitive spine surgery devices are getting introduced like microsurgical techniques and minimally invasive techniques which has successfully made to stabilize every segment of the spine. In spine surgeries, there are chances of increased bleeding due to the close network of epidural venous plexus. Due to increased bleeding and decreasing the visibility of the surgical field there is an increased chance of severing a nerve.

Controlled hypotension means to reduce Mean Arterial Pressure (MAP) to 60-70 mmHg or a 30% decrease in the baseline value. Decrease in intraoperative blood pressure leads to a direct reduction in bleeding from surgically injured arteries and arterioles. This decreases the intraoperative blood loss and facilitates surgical exposure and further reduces transfusion dependence.

Numerous pharmacological agents have succeeded in controlling MAP. The ideal agent used for controlled hypotension should be easy to administer, have a short onset time, effect that disappears quickly when administration is discontinued, rapid elimination without toxic metabolites, negligible effects on vital organs and predictable and dose-dependent effects.

Magnesium sulphate

Magnesium sulphate causes hypotension by :

          1.    limiting the outflow of calcium from the sarcoplasmic reticulum

2.    acts as a vasodilator by increasing the synthesis of prostacyclin

3.    inhibiting angiotensin converting enzyme (ACE) activity.

Magnesium sulphate also has analgesic action due to its antagonistic effect at N-methyl D-aspartate (NMDA) receptors which inhibits norepinephrine release by blocking N-type and partially L-type calcium channels.

 

Dexmedetomidine

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, anxiolytic and analgesic characteristics.

Dexmedetomidine activates central 2A and imidazoline type 1 receptors which causes decrease in norepinephrine release and leads to a decrease in blood pressure and heart rate.

There have not been many studies comparing the effect of magnesium sulphate and dexmedetomidine with each other in spine surgeries. Hence our study aims to bridge the gap between these two drugs for achieving hypotension to decrease bleeding and increase the surgical visibility without any adverse effects of the drug. This observational study is designed with the aim of obtaining clinical evidence on a potentially different effect of dexmedetomidine versus magnesium sulphate in hypotensive anaesthesia during spine surgery.


 
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