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CTRI Number  CTRI/2026/02/103884 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 13/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Does a pill called midodrine taken before surgery help to prevent blood pressure drops after IV anaesthesia starts 
Scientific Title of Study   Efficacy of preoperative oral midodrine as a prophylaxis against post induction hypotension in patients undergoing elective surgery under general anaesthesia 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prakash raj B 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical care medicine , 3rd floor , Emergency building, All India Institute of Medical Sciences, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9003506698  
Fax    
Email  prakase15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep Kumar bhatia 
Designation  Professor and head of department  
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical care medicine , 3rd floor , Emergency building, All India Institute of Medical Sciences, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9829159665  
Fax    
Email  pk_bhatia@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeep Kumar bhatia 
Designation  Professor and head of department  
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical care medicine , 3rd floor , Emergency building, All India Institute of Medical Sciences, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9829159665  
Fax    
Email  pk_bhatia@yahoo.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Jodhpur  
Address  All India Institute of Medical Sciences, Basni, Phase 2, Jodhpur, Rajasthan- 342005 
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 Prakashraj B  All India Institute of Medical Sciences, Jodhpur   Adult Intensive Care Unit, Department of Anaesthesiology and Critical Care Medicine, 3rd Floor, Emergency Block, Marudhar Industrial Area, 2nd Phase, Basni, Jodhpur
Jodhpur
RAJASTHAN 
9003506698

Prakase@15gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Jodhpur   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 
Intervention  Preoperative oral midodrine  The study aims to evaluate the incidence of post induction hypotension with general anaesthesia after preoperative oral midodrine. Patients with hypertension, DM, cardiac issues, kidney and liver problems, pheochromocytoma , thyrotoxicosis will be excluded. We would randomize the patient 90 mins before procedure to receive either 5mg midodrine[group A] or placebo[group B] 60 mins before the procedure we would ask the patient to take midodrine . After induction MAP & HR would be monitored every 2 mins for 20 mins after induction.  
Comparator Agent  Preoperative placebo( Multivitamin tablet)  The study aims to evaluate the incidence of post induction hypotension with general anaesthesia after preoperative oral midodrine. Patients with hypertension, DM, cardiac issues, kidney and liver problems, pheochromocytoma , thyrotoxicosis will be excluded. We would randomize the patient 90 mins before procedure to receive either 5mg midodrine[group A] or placebo[group B]. 60 mins before the procedure we would ask the patient to take placebo( Multivitamin tablet). After induction MAP & HR would be monitored every 2 mins for 20 mins after induction.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All ASA 1 patients who needs Surgical intervention under General Anaesthesia included in this study 
 
ExclusionCriteria 
Details  Hypertensive patient, DM, Known cardiac patients, CKD, Liver disease patients, Urinary retention, Pheochromocytoma, Thyrotoxicosis, Patients whose are taking Digitalis and beta blockers, glaucoma
 
 
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 find out the incidence of post induction hypotension with General anaesthesia after preoperative medication with oral midodrine 5mg  Patients vitals will be monitored from the time of induction to 20 minutes of induction ..
study will be continued over period of 1 year after the date of enrolment 
 
Secondary Outcome  
Outcome  TimePoints 
To find:
Intraoperative phenylephrine consumption.
Measurement of serial change in MAP & HR after induction.
Incidence of Frequency of complications like reactive hypertension & bradycardia.
 
Patient vitals will be monitored from the time of induction to 20 minutes of induction, study will be continued over a period of 1 year after the date of approval 
 
Target Sample Size   Total Sample Size="414"
Sample Size from India="414" 
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)   27/02/2026 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Post induction hypotension is defined as arterial hypotension which occurred within 20mins of anaesthesia induction or from anaesthesia induction till the beginning of surgical incision. Worldwide the incidence of post GA induction hypotension increased upto 66%. Hypotension was defined as either MAP decrease of >40% and MAP <70mmHg or MAP<60mmHg. Propofol causes hypotension by decreasing peripheral vascular resistance. Intraoperative hypotension compromises vital organ perfusion which consequently increase the risk of kidney injury, brain ischemia, cardiac ischemia and postop ICU admission. During this post induction hypotension alpha adrenoceptor agonist, such as ephedrine, phenylephrine and norepinephrine are used. In this study oral midodrine will be used as prophylaxis against post induction hypotension . Midodrine hydrochloride is another alpha Adrenoceptor agonist which has the advantage of being an oral drug with minimal CNS side effect and good oral bioavailability. Midodrine is a prodrug, metabolized to Desglymidodrine[DGM] by the process called deglycination. This DGM act on alpha 1 receptors in the arteriolar and venous system cause constriction of vessels. In this study we aimed to evaluate the incidence of post GA induction hypotension after preoperative medication with oral midodrine 5mg [60 min before Sx]. 

The study aims to evaluate the incidence of post induction hypotension with general anaesthesia after preoperative oral midodrine. Patients with hypertension, DM, cardiac issues, kidney and liver problems, pheochromocytoma , thyrotoxicosis will be excluded. We would randomize the patient 90 mins before procedure to receive either 5mg midodrine[group A] or placebo[group B].60 mins before the procedure we would ask the patient to take midodrine or placebo. After induction MAP & HR would be monitored every 2 mins for 20 mins after induction. 

 
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