| 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
|
|
|
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
|
|
|
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
|
|
|
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. |