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CTRI Number  CTRI/2024/09/073332 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 01/09/2024
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   Study to compare the efficacy of intravenous phenylephrine infusion versus intravenous Ramosetron in the prevention of hypotension post spinal anaesthesia for patients undergoing elective surgery for inguinal hernia i.e. herniorhhaphy/hernioplasty 
Scientific Title of Study   Study on comparison of prophylactic phenylephrine infusion versus intravenous ramosetron on hypotension during spinal anaesthesia for herniorhhaphy , hernioplasty : A Randomized controlled trial 
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 SACHIN KUMAR 
Designation  Junior Resident 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anaesthesia , Rajendra institute of medical sciences , Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  7677093479  
Fax    
Email  sachin.rocks171717@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DIPALI SINGH 
Designation  ADDITIONAL PROFESSOR 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anaesthesia , Rajendra institute of medical sciences , Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  9620310511  
Fax    
Email  dipalishio@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR BHARATI 
Designation  ASSISSTANT PROFESSOR 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anaesthesiology , Rajendra institute of medical sciences , Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  9599277395  
Fax    
Email  bharati.bediya@gmail.com  
 
Source of Monetary or Material Support  
Rajendra institute of medical sciences , Ranchi , Jharkhand Country : India Pincode : 834009  
 
Primary Sponsor  
Name  RAJENDRA INSTITUTE OF MEDICAL SCIENCES 
Address  Bariatu , Ranchi , Jharkhand , India , Pincode : 834009 
Type of Sponsor  Government 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 SACHIN KUMAR  RAJENDRA INSTITUTE OF MEDICAL SCIENCES  Surgery opearation theatre , 2nd floor , dpertment of surgery
Ranchi
JHARKHAND 		 7677093479

sachin.rocks171717@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K40-K46||Hernia, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% Normal saline  infusion normal saline will be administered in 10 ml syringe 5 min before puncture and i.v. infusion of normal saline started post spinal puncture  
Intervention  Phenylephrine  In patients receiving prophylactic phenylephrine infusion i.v. infusion of phenylephrine(25 μg.min−1 ) will be started post puncture and continued for 30 minutes post spinal  
Intervention  Ramosetron  In patients receiving prophylactic Ramosetron, injection ramosetron 0.3 mg diluted with normal saline upto 10 ml will be given 5 mintues prior to spinal puncture via intravenous route.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patient
ASA status type I or II. Patient of inguinal hernia undergoing Elective Surgery requiring spinal anaesthesia. Patient height between 160 c.m. – 170 c.m.
 
 
ExclusionCriteria 
Details  Patient having known allergy to any of medication to be used in the study(phenylephrine and ramosetron). Emergency cases. Patient having other comorbidities. ASA status type 3 and 4.
 
 
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 compare the efficacy of intravenous phenylephrine infusion(25 μg.min−1) versus intravenous Ramosetron(0.3mg) versus 0.9% Normal saline (placebo) infusion in the prevention of hypotension post spinal anaesthesia for patients undergoing elective surgery for inguinal hernia i.e. herniorhhaphy/hernioplasty.

Mean Arterial pressure , systolic and diastolic blood pressure and Heart rate will bw measured. 		 pre induction

post spinal puncture

At every 2 minutes interval for first 15 minutes

Then at every 5 minutes for next 15 minutes

Then at every 10 minutes interval for rest of duration of surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of episodes of nausea and vomiting between three groups.
 		 post spinal puncture till end of surgery. 
To compare the incidence of episodes of skin flushing and other patient discomfort between three groups.
 		 post spinal puncture till end of surgery 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   Phase 4 
Date of First Enrollment (India)   30/09/2024 
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="1"
Months="0"
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   Spinal anaesthesia is the most commonly used anaesthetic technique for elective herniorhhaphy/hernioplasty . It has many advantages over other techniques; it is quicker , easier and less invasive compared to epidural anaethesia and general anaesthesia . also the patient is exposed to less drugs compared to general anaesthesia. However, spinal anaesthesia has multiple drawbacks. It can induce hypotension, which leads to nausea, vomiting, and dizziness. It also causes post spinal shivering in many patients
Multiple interventions have been proposed to prevent the incidence of such complications including intravenous fluid infusion, leg compression, and vasopressors (norepinephrine, ephedrine, phenylephrine,  mephentermine).  Furthermore, a previous study has reported that 5-HT3 receptor antagonists such as ondansetron , ramosetron  can prevent hypotension by preventing serotonin induced bradycardia.
So this study is being conducted to compare the efficacy of prophylactic phenylephrine infusion ( 25 mcg/min ) versus single prophylactic dose of intravenous ramosetron ( 0.3 mg ) on the incidence of hypotension post spinal anaesthesia in patients undergoing elective herniorhhaphy/hernioplasty.
 
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