| 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
|
|
|
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
|
|
|
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) . |