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CTRI Number  CTRI/2022/10/046431 [Registered on: 13/10/2022] Trial Registered Prospectively
Last Modified On: 13/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the hemodynamic changes for phenylephrine and glycopyrrolate drugs after spinal anesthesia in pregnant patients posted for lower segment caesarean section 
Scientific Title of Study   Comparison of hemodynamic changes between phenylephrine and glycopyrrolate group after spinal anesthesia for caesarean delivery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mooli Pranisha 
Designation  PG student 
Affiliation  krishna institute of medical sciences  
Address  krishna institute of medical sciences hospital "Deemed To Be University"karad, Depatment of anesthesia , operation theatre.

Satara
MAHARASHTRA
415539
India 
Phone  8340857237  
Fax    
Email  mooli.pranisha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrNVKanase 
Designation  Associate professor 
Affiliation  krishna institute of medical sciences  
Address  krishna institute of medical sciences hospital "Deemed to be university" Karad Department of Anesthesiology, Operation theatre

Satara
MAHARASHTRA
415539
India 
Phone    
Fax    
Email  naseemakanase@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Mooli Pranisha 
Designation  PG student 
Affiliation  krishna institute of medical sciences " deemed to be university " 
Address  krishna institute of medical sciences "Deemed to be University" Karad Department of anesthesiology, Operation theatre

Satara
MAHARASHTRA
415539
India 
Phone  8340857237  
Fax    
Email  mooli.pranisha@gmail.com  
 
Source of Monetary or Material Support  
krishna institute of medical sciences "Deemed To Be University" Karad , Department of Anesthesiology , Operation theatre , Maharashtra , 415539 
 
Primary Sponsor  
Name  krishna institute of medical sciences 
Address  NH4 pune banglore highway agashivnagar malkapur maharashtra 415539 
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 Mooli Pranisha  krishna institue of medical sciences  Department of anesthesiology operation theatre
Satara
MAHARASHTRA 
8340857237

mooli.pranisha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee of krishna institute of medical sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glycopyrrolate  Group G: glycopyrrolate 0.2mg given as bolus dose after spinal anesthesia in caesarean delivery and hemodynamic changes are noted at 1,3,5,7,9,11,13,15mins.  
Intervention  Phenylephrine   Group p: phenylephrine infusion 50mcg/min given for 15mins after spinal anesthesia in caesarean delivery and hemodynamic changes are noted at 1,3,5,7,9,11,13,15mins.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Parturients belonging to ASA 1 and 2
Age 20 to 35 years 
 
ExclusionCriteria 
Details  Patients with cardiovascular disease
Patients with cerebrovascular disease
Pregnancy related hypertensive disease and diabetes mellitus
Height less than 150cms or more than 180cms
Weight less than 50kg or more than 100kgs
Known fetal abnormalities
Contraindications to glycopyrrolate
Fever
Twin pregnancies 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.TO study and compare the severity of hypotension and bradycardia in parturients undergoing caesarean section under spinal anesthesia
2.And to study and compare the side effects nausea and vomiting  
1. maternal data such as age , BMI , baseline heart rate (HR) , systolic and diastolic blood pressure (SBP,DBP) , mean arterail pressure (MAP)
2. HR,SBP,DBP measured for 15mins after induction of subarachnoid block .
3.incidence if hemodynamic adverse effects. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil
 
Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   13/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/10/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

AIM To study the efficacy of prophylactically intravenous administration of phenylephrine and glycopyrrolate to attenuate the hemodynamic responses of parturient during cesarean delivery under spinal anesthesia.

 

OBJECTIVES To study and compare the severity of hypotension and bradycardia in parturient undergoing cesarean section under spinal anesthesia. And to study and compare the side effects i.e. nausea and vomiting in parturient undergoing cesarean section under spinal anesthesia 

METHOD In my study  patients posted for elective cesarean section  under spinal anesthesia will be randomly allocated into two groups (30 each) , Phenylephrine group [P] and glycopyrrolate group [G]  after explaining the procedure to patient and informed consent . 

PROCEDURE : Pre anesthetic checkup and preparation : In my study  patients posted for elective cesarean section  under spinal anesthesia will be randomly allocated into two groups (30 each ) , phenylephrine group [P] and glycopyrrolate group [G]  after explaining the procedure to patient and written informed consent . An 18-gauge intravenous cannula will be established in a forearm and preloaded with Hartmann solution of 10ml/kg .Premedication with Inj Ranitidine 0.5-1 mg/kg and Inj Metaclopramide 0.1-0.15 mg/kg will be  given in recovery to all patients. After shifting the patient in OR standard monitors i.e., heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) and oxygen saturation (sPO2) will be connected and baseline readings will be recorded . Spinal Anesthesia will be given to  patients in left lateral position with 25guage spinal needle at L3-4 or L4-5 vertebral interspace with 0.5% heavy Bupivacaine 2.2ml . Immediately after spinal anesthesia.  

In P GROUP: The phenylephrine infusion will be started at a rate of 50 μg/min for 15 min and the hemodynamic values will be recorded at [1,3,5,7,9,11,13,15mins]. and at the same time 1cc of normal saline in 2cc syringe for double blinding. If the SBP is 30% above the baseline, the infusion will be stopped. If SBP ≤ 30%of baseline for 2 consecutive readings, despite the phenylephrine infusion, will be treated with a bolus of phenylephrine 50 μg.   If HR falls <60bpm Inj glycopyrrolate will be given IV (0.2mg)  .Total phenylephrine infusion dose given over 15mins will be recorded.

In G GROUP:  In group G , glycopyrrolate will be injected 1cc of 0.2 mg  intravenously in 2cc syringe after spinal anesthesia . If SBP is 30% below the baseline, phenylephrine bolus dose of 50mcg will be  given and recorded.If HR falls <60bpm  Inj Atropine will be given IV (0.6mg) in 1cc  .Hemodynamic changes will be recorderedover 15mins ( 1,3 ,5,7,9,11,13,15mins) .

 
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