| CTRI Number |
CTRI/2022/12/047845 [Registered on: 02/12/2022] Trial Registered Prospectively |
| Last Modified On: |
30/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the impact of prophylactic infusion of two different doses of phenylephrine on maternal hypotension and outcome of newborns in females undergoing cesarean section under spinal anaesthesia. |
|
Scientific Title of Study
|
A study to compare the effect of prophylactic infusion of two different doses of phenylephrine on maternal hypotension and neonatal outcome in females undergoing cesarean section under spinal anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashita Rukmini |
| Designation |
Second year Anaesthesia postgraduate resident |
| Affiliation |
Maharishi Markandeshwar University,Mullana |
| Address |
Department of Anaesthesia,MM Institute of Medical Sciences and Research Centre,Mullana,Ambala
Ambala
HARYANA
133207
India |
| Phone |
9896389305 |
| Fax |
|
| Email |
ashitarukmini44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Babita Ramdev |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar University,Mullana |
| Address |
Department of Anaesthesia,MM Institute of Medical Sciences and Research,Mullana,Ambala
Ambala
HARYANA
133207
India |
| Phone |
7888554917 |
| Fax |
|
| Email |
babitaramdev30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Babita Ramdev |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar University,Mullana |
| Address |
Department of Anaesthesia,MM Institute of Medical Sciences and Research,Mullana,Ambala
Ambala
HARYANA
133207
India |
| Phone |
7888554917 |
| Fax |
|
| Email |
babitaramdev30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,MM Institute of Medical Sciences and Research Centre,Mullana,Ambala |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
MM Institute of Medical Sciences and Research Centre,Mullana,Ambala |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashita Rukmini |
MM Institute of Medical Sciences and Research Centre |
Department of anaesthesia,2nd floor,Old Building OT complex.
Ambala
HARYANA |
9896389305
ashitarukmini44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,MMIMSR,Mullana,Ambala |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection phenylephrine 25 mcg vs 50mcg per minute |
To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 vs 50 micrograms/minute) administered for 3 minutes after insertion of spinal drug in parturients undergoing caesarean section under spinal anaesthesia.And to asses its effect on intraoperative maternal hemodynamics and neonatal outcomes. |
| Intervention |
Spinal anaesthesia |
To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 vs 50 micrograms/minute) administered for 3 minutes after insertion of spinal drug in parturients undergoing caesarean section under spinal anaesthesia.And to asses its effect on intraoperative maternal hemodynamics and neonatal outcomes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with physical status ASA grade I or II.
2. All patients giving written informed consent.
3. Patients with gestation age > 36 weeks posted for elective caesarean delivery under spinal anaesthesia.
4. Patients belonging to age group of 18 to 35 years.
|
|
| ExclusionCriteria |
| Details |
1. Parturients with complications like risk of excessive bleeding (placenta previa, prolonged labor, abnormal presentation, multiple gestation)
2. Patients with pre-existing or pregnancy induced hypertension or maternal SBP< 100mm Hg.
3. Patients with cardiovascular disease, cerebrovascular disease, severe anemia or diabetes.
4. Patients with known fetal abnormalities.
5. Patients with contraindication to spinal anaesthesia.
6. Patients with known allergy to phenylephrine
7. Patients with inability or refusal to give informed consent
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 and 50 micrograms/minute) on maternal hemodynamics and neonatal outcomes in parturients undergoing caesarean section under spinal anaesthesia.
-To assess the changes in maternal blood pressure
-To assess the changes in maternal heart rate.
|
From administration of spinal anaesthesia intraoperstively till the end of the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 and 50• micrograms/minute) on maternal hemodynamics and neonatal outcomes in parturients undergoing caesarean section under spinal anaesthesia.
•To assess the incidence of nausea and vomiting
•To assess the fetal outcomes in terms of APGAR score and acidosis.
|
From administration of spinal anaesthesia intraoperstively till the end of the surgery. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Spinal anaesthesia is nowadays preferred over General anaesthesia for caesarean sections as it not only overcomes the complications associated with general anaesthesia but also provides more effective pain control, early ambulation and better maternal and fetal outcomes.Intraoperative hypotension is defined as decrease in mean blood pressure less than 20% of patient’s baseline value. It can occur after spinal anaesthesia and may have deleterious effects on maternal and fetal outcomes.The effects of various vasopressors like ephedrine, nor-epinephrine, mephenteramine, phenylephrine, etc. have been studied in the prevention of spinal hypotension.Considering the influences on fetomaternal physiology like minimal placental passage, less incidence of fetoacidosis and maternal nausea, vomiting, etc. phenylephrine has been found to be the vasopressor of choice.Therefore we will be doing this random prospective study to compare two rates of infusion of phenylephrine (25 and 50 micrograms/minute) in preventing maternal hypotension caused by spinal anaesthesia and neonatal outcomes in patients undergoing caesarean section. |