RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II
SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1.

Name of the candidate

DR. MEGHA G.H

and Address

P.G. IN ANAESTHESIOLOGY

(In Block Letters)

DEPT OF ANAESTHESIOLOGY
VIMS, BELLARY
PIN 583 104

2.

Name of the Institute

VIJAYANAGAR INSTITUTE OF MEDICAL

SCIENCES, BELLARY, KARNATAKA.

3.

Course of Study and

MEDICAL M.D. IN ANAESTHESIOLOGY

4.

Subject
Date of Admission to

12-03-2008

5.

Course
Title of Topic

COMPARATIVE EFFICACY OF BOLUS

DOSES FOLLOWED BY INFUSIONS OF
PHENYLEPHRINE AND EPHEDRINE IN
MAINTAINING ARTERIAL PRESSURE
DURING SPINAL ANAESTHESIA IN
CAESAREAN SECTIONS.

6.

BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY
Sub arachnoid block is the anaesthetic technique of choice for caesarean
sections because of various advantages for mother and fetus. However
hypotension is a frequent intra operative complication that occurs following spinal
anaesthesia.
Hypotension may be detrimental to mother as well as fetus because of

placental hypo perfusion. It is therefore important to find an effective method to

prevent and treat hypotension during spinal anaesthesia.
Hypotension has traditionally been managed by measures such as fluid
preloading, prophylaxis and therapeutic vasopressor along with left uterine
displacement throughout the surgery.
Vasopressors used for prophylaxis and treatment of hypotension should
fulfill the following criteria i.e., high efficacy, ability to use liberal doses to
maintain maternal blood pressure near normal preventing hypotension induced
fetal acidemia.4
Standard choice of vasopressor agents for prophylaxis or treatment of
spinal hypotension in caesarian sections is still a controversial issue.3
Earlier ephedrine was considered the sole choice of vasopressor for
treatment of spinal hypotension. It has both alpha and beta adrenergic agonistic
action, increasing cardiac output, heart rate and systolic blood pressure but
ephedrine crosses placenta and thus may contribute to fetal acidosis.
Phenylephrine is the vasopressor that most closely meets the criteria for the
ideal vasopressor in obstetrics.
It is a short acting alpha agonist and increases maternal blood pressure with
a transient reactive bradycardia, responsive to atropine. It can be administered by
bolus as well as by infusion, in titrated doses as per the blood pressure response.
The present study is undertaken to reduce the risk of hypotension during
spinal anaesthesia in caesarean section by administration of an initial bolus dose
followed by infusion of either phenylephrine or ephedrine along with their effects
on neonatal outcome.

6.2 REVIEW OF LITERATURE

Sahu D, kotharid et al in a study of comparison of bolus phenylephrine

and ephedrine showed hypotension is a most common intra operative
complication in spinal anaesthesia.1
Moran DH, Penillo M et al, in a comparative study of phenylephrine and
ephedrine, found that phenylephrine is as effective as ephedrine in the treatment
of maternal hypotension, when used in small incremental bolus injections, without
any adverse neonatal effect.3
La porta RF, Arthur GR, et al they found that phenylephrine appears to be
as safe as ephedrine and effective in the treatment of drop in the blood pressure.
The use of phenylephrine was however associated with significantly lower noradrenaline concentration in both mother and neonate, as compared to ephedrine.4
Thomas DG, Robson et al in a randomized trial of bolus phenylephrine and
ephedrine for maintenance of arterial pressure during spinal anaesthesia, showed
that phenylephrine has no detrimental effects on fetal hemodynamic state or
umbilical artery pH. Although the incidence of maternal bradycardia was increased
in women given phenylephrine there were no significant differences in maternal
cardiac out put between the two groups.5
A quantitative systematic review of randomized controlled trials of ephedrine
versus phenylephrine for management of hypotension during spinal anaesthesia
for caesarean section by Lee A Nagan k showed that women given ephedrine had
neonates with lower umbilical cord pH, which was not significant and needed no
intervention; women given phenylephrine had neonates with higher umbilical cord
pH.7

6.3 OBJECTIVES OF THE STUDY

A.

Efficacy of phenylephrine and ephedrine in maintaining maternal blood

pressure intra operatively during spinal anaesthesia for caesarean
section.

B.

Fetal and neonatal outcome in the two groups.

C.

Side-effects, if any, associated with the test drugs.

MATERIAL AND METHODS.

7.

7.1 SOURCE OF DATA The study is conducted in 100 patients of 18 to 35

yrs of age scheduled to undergo caesarean section under spinal anaesthesia at
VIMS Hospital Bellary. The study will be conducted in the department of
Anaesthesiology VIMS Bellary for the period of one year from 01-12-2008 to
31-11-2009
The patients are included in the study by applying the following
Inclusion and exclusion criteria.
Inclusion criteria
a. Patients of normal singleton pregnancy beyond 36 weeks gestation posted
for caesarean section.
b. Patients belonging to ASA I & II
c. Age 18 35 years.
Exclusion criteria
a) Patient refusal for the procedure
b) Patients with significant coagulopathies and other contra-indications for
spinal anaesthesia.
c) Patient with pregnancy induced hypertension
d) Patients with history of significant systemic disorders (cardiovascular,
respiratory or central nervous system).
7.2 METHODS OF COLLECTION OF DATA (Including sampling
procedure if any)
-

During the above said study period 100 patients posted for
caesarean sections under spinal anaesthesia are randomly selected
and allolted to one of the two groups Group P-phenylephrine,
Group E- Ephedrine .

Patients are explained about the procedure and informed / written

consent obtained.

Two intravenous lines are established.

Patient pre-loaded 500ml Ringer lactate

Pre-medicated with Inj-Ranitidine 50mg I.V

Inj-Ondensetron 4mg I.V

15minites after pre-medication, patients basal parameters Heart

rate, saturation, blood pressure and ECG, monitored using pulse
oximetry, Noninvasive blood pressure and ECG monitor.

With continuous maintenance of left uterine displacement and

keeping table flat, under aseptic precaution using 25g Quincke
needle, inj.bupivacaine heavy (0.5%) of 1.8ml. injected
intrathecally.

Immediately after spinal injection patient is repositioned with the

maintainence of left uterine displacement I.V bolus of test drug given.
Group P phenylephrine of 20micrograms I.V bolus followed by
infusion of 10micrograms per min for 30minutes.
Group E ephedrine 6mg I.V bolus followed by infusion of
1mg/minute for 30minutes
Monitoring of heart rate, blood pressure, saturation & ECG done at 1st,
2nd , 3rd, 4th, 5th, 7th, 9th and 10th minute, after that for every 3mins till the end of
surgery.
Fall in BP > 15% of the basal is treated with increased rate of iv fluid
infusion and followed if necessary ,by a second bolus of same drug .7
Fall in heart rate < 60 bpm for > 30sec treated by atropine I.V 0.3mg
with an increment upto maximum of 3mg.
Fall in Spo2 < 95% is managed by oxygen supplementation via clear
(Hudsons) face mask at 4 liters per min.
Neonatal status is assessed by Apgar scoring.

Post operative monitoring of the patient is continued in the post

anesthesia care unit for 1 hour.

7.3 Does the study require any investigation or intervention to be conducted

on patients or other humans or animals? If so please describe briefly?
Yes, The following are done pre-operatively

Blood investigations: Hb%, Bleeding time, Clotting time, Blood grouping

and Rh typing, blood sugar, blood urea and serum creatinine.

Urine: albumin, sugar & microscopy.

Ultra sound scan.

Informed/ written consent will be obtained from each patient before

starting the study. All the patients parent/legal guardian are supplied with
patient information sheet before taking the consent.

All the investigations and interventions are done under the direct guidance and
supervision of our guide.

7.4 Has ethical clearances been obtained from your institution in case of 7.3
YES, Ethical clearance has been obtained from VIMS Institutional Ethics
committee, VIMS, Bellary.
8.

LIST OF REFERENCES

1. Sahu D, Kothari D, Menrotra A. Comparison of bolus phenylephrine,

ephedrine and mephentermine for maintenance of arterial pressure
durig spinal anaesthesia in caesarean section. A clinical study. Indian
J Anaesth 2003; 47(2):125-128.
2. Kee N, Worwick D,Kim SK. Vasopressors in obstetrics: What should
we be using? Current opinion in Anaesthesiology 2006; 19(3):238243.
3. Moran DH, Pevillo M, Laporta RF, Bader AM, Datta S.
Phenylephrine in the prevention of hypotension following spinal
anaesthesia for caesarean delivery. J Clin Anaesth 1991; 3(4):301-5.
4. LaPorta RF, Arthur GR, Datta S. Phenylephrine in treating maternal
hypotension due to spinal anaesthesia for caesarean delivery: effects
on neonatal catecholamine concentrations, acid base status and Apgar
scores. Acta Anaesthesiol Scand 1995; 39(7):901-5.
5. Thomas DG, Robson SC, Redtern N, Hughes D, Jones R
Randomized trial of bolus phenylephrine or ephedrine for
maintenance of arterial pressure during spinal anaesthesia for
caesarean section. Br.J Anaesth 1996; 76:61-65.

6. Lee A, Nagan K, Werwidk D, Tony G.A quantitative, systematic

review of randomized controlled trials of ephedrine versus
phenylephrine for the management Analg 2002;94(4):920-6.
7. Kansal A, Mohta M, Sethr AK. Randomized trials of intravenous
infusion of ephedrine or mephentermine for management of

hypotension during spinal anaesthesia for caesarean section.

Anaesthesia 2005; 60(1):28-34.
8. Stoelting RK. Pharmacology and Physiology in anaesthetic practice:
4th ed. Lipptncot Willian Wilkins Publishers 2006;p.303-305.
9. David W.Cooper, Mark Carpenter, Paul Mowbray, William R.Desira,
David M. Ryall, and Manmohan S. Kokri Fetal and Maternal Effects
of Phenylephrine and Ephedrine during Spinal Anesthesia for
Cesarean Delivery Anesthesiology, 97:1582-1590, 2002.
10. Hiroshi Ueyama, M.D: Yuki Hiuge, M.D. : Masaki Takashina, M.D. :
Takashi Mashimo, M.D. Maternal Cardiovascular effects of
Prophylactic ephedrine and Phenylephrine for Elective Cesarean
Section Undergoing Spinal Anesthesia American Society of
Anesthesiologists October 18-22, 2008.

9.

SIGNATURE OF THE
CANDIDATE

10.

REMARKS OF THE GUIDE

11.

NAME & DESIGNATION (IN

BLOCK LETTERS)

The present study is done to evaluate the

efficacy of phenylephrine and
ephedrine with respect to hemodynamic
stability in spinal anesthesia in caesarean
sections.

11.1 GUIDE

DR. B. DEVANAND. M.D.DNB.DA

PROFESSOR & HOD
DEPT.OF.ANAESTHESIOLOGY
VIMS, BELLARY

11.2 SIGNATURE
11.3 CO-GUIDE (IF ANY)
11.4 SIGNATURE
11.5 HEAD OF THE

DR. B.DEVANAND. M.D.DNB.DA

DEPARTMENT

PROF. & HEAD OF DEPARTMENT

ANAESTHESIOLOGY
VIMS, BELLARY

11.6 SIGNATURE

12.

12.1 REMARKS OF THE

CHAIRMAN & PRINCIPAL
12.2 SIGNATURE

FROM,
THE PROFESSOR, AND HEAD OF THE DEPARTMENT
DEPARTMENT OF ANAESTHESIOLOGY,
VIMS, BELLARY.
TO,
THE PRINCIPAL,
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES,
BELLARY.
Through proper channel

Sir,
As per the regulations of the university of the Dissertation topic, the following post
graduate student in M.D DEGREE IN ANAESTHESIOLOGY has been allotted the
Dissertation topic as follows by the official registration committee of all qualified and
eligible guides of the Department of Anaesthesiology
NAME
DR. MEGHA G.H

TOPIC
COMPARATIVE

GUIDE
DR.B.DEVANAND. M.D.DNB .DA

P.G IN

EFFICACY OF BOLUS

PROFESSOR & HOD

ANAESTHESIOLOGY

DOSES FOLLOWED BY

DEPT.OF.ANAESTHESIOLOGY

DEPARTMENT OF

INFUSIONS OF

VIM S, BELLARY

ANAESTHESIOLOGY

PHENYLEPHRINE AND

VIMS, BELLARY

EPHEDRINE IN

PIN-583104

MAINTAINING
ARTERIAL PRESSURE
DURING SPINAL
ANAESTHESIA IN
CAESAREAN
SECTIONS.

Therefore I request you to kindly communicate the acceptance of the dissertation topic
allotted to the P.G student at an early date.
Thanking you

FROM,
THE PROFESSOR, AND HEAD OF THE DEPARTMENT
DEPARTMENT OF ANAESTHESIOLOGY,
VIMS, BELLARY.
TO,
THE REGISTRAR,
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE,
KARNATAKA.
Sir,

Yours faithfully,

Through proper channel

As per the regulations of the university of the Dissertation topic, the following post
graduate student in M.D DEGREE IN ANAESTHESIOLOGY has been allotted the
Dissertation topic as follows by the official registration committee of all qualified and
eligible guides of the Department of Anaesthesiology
NAME

DR. MEGHA G.H

P.G IN
ANAESTHESIOLOGY
DEPARTMENT OF
ANAESTHESIOLOGY
VIMS, BELLARY
PIN-583104

TOPIC

COMPARATIVE
EFFICACY OF BOLUS
DOSES FOLLOWED BY
INFUSIONS
OF
PHENYLEPHRINE
AND EPHEDRINE IN.
MAINTAINING
ARTERIAL PRESSURE
DURING
SPINAL
ANAESTHESIA
IN
CAESAREAN
SECTIONS.

GUIDE

DR.B.DEVANAND. M.D. DNB.DA

PROFESSOR & HOD
DEPT.OF.ANAESTHESIOLOGY
VIMS, BELLARY

Therefore I request you to kindly communicate the acceptance of the dissertation topic
allotted to the P.G student at an early date.
Thanking you

FROM,
DR. MEGHA G.H
P.G. IN ANAESTHESIOLOGY
DEPT OF ANAESTHESIOLOGY
VIMS, BELLARY
PIN-583104
TO,
THE PRINCIPAL,
VIJAYNAGAR INSTITUTE OF MEDICAL SCIENCES,
BELLARY.

Yours faithfully,

Place:Bellary
Date:

THROUGH PROPER CHANNEL

Respected sir,
Sub: ACCEPTANCE, REGISTRATION AND FORWARDING OF TOPIC
In accordance with the above cited topic, I the undersigned studying in P.G course
in M.D DEGREE IN ANAESTHESIOLOGY have been allotted the Dissertation topic
COMPARATIVE

EFFICACY

OF

BOLUS

DOSES

FOLLOWED

BY

INFUSIONS OF PHENYLEPHRINE AND EPHEDRINE IN MAINTAINING

ARTERIAL PRESSURE DURING SPINAL ANAESTHESIA IN CAESAREAN
SECTIONS. under the guidance of DR. B.DEVANAND M.D. Professor & HOD,
Department of Anaesthesiology, VIMS, Bellary.
I request you to kindly forward the dissertation topic in the prescribed form to the
university for approval.
Thanking you,

Yours faithfully
(DR. MEGHA G.H )

GUIDE