RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE - II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / Name of the Candidate & Address
(In block letters) / : /
Dr.VIRAJ S.PATIL
POST GRADUATE
DEPARTMENT OF ANAESTHESIOLOGY,
M.R. MEDICAL COLLEGE,
GULBARGA-585 105.
Permanent Address / : / Dr.VIRAJ S.PATIL
H.No. 35/D2,
SHANTI NAGAR, K.H.B. COLONY,
M.S.K. MILL ROAD, GULBARGA-585 103.
2. / Name of the Institution / : / H.K.E. SOCIETY’S
MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA – 585 105.
3. / Course of Study and Subject / : / M.D. (ANAESTHESIOLOGY)
4. / Date of Admission to Course / : / 24.05.2007
5. / Title of the Topic / : / LOW DOSE OF INTRAVENOUS KETAMINE FOR PREVENTION OF SPINAL HYPOTENSION
6. /
Brief resume of the intended work
6.1 / Need for the study:
The study is conducted to evaluate the role of low doses of intravenous ketamine in prevention of spinal hypotension and also to assess its utility as supplementary sedation in combination with diazepam.
A reduction in blood pressure is an accompaniment of spinal anaesthesia. Sympathetic blockade is the major determinant of physiologic responses to subarachnoid anaesthesia. Paralysis of the sympathetic vasoconstrictor fibers occurs in arterioles, capillaries and veins at the preganglionic level of block and thereby produces various dramatic indirect physiologic effects.
Hypotension during spinal anaesthesia can be partially controlled by infusions and vasopressor therapy but infusion of a large volume of crystalloids over a short period of time carries risk of pulmonary oedema and postoperative urinary retention. Among vasopressors drugs like ephedrine, mephenteramine, etc. have been tried, but they may cause deleterious effects like overshoot hypertension, impaired tissue perfusion and marked vasoconstriction especially in renal and coronary vessels.
Ketamine induces activation of sympathetic nervous system and increases catecholamine levels in the blood thereby increasing pulse rate and blood pressure. Cardiovascular stability is far better with low dose ketamine supplementation because it has cardiotonic effects. Respiratory depression is not seen with low doses of ketamine.
Consciousness, prolonged posture maintenance and awareness during spinal anaesthesia always cause apprehension to the patient. Thus supplementary sedation is always needed during regional blocks, which can be achieved with ketamine.
6.2 / Review of Literature:
1. / Hemmingsen C and Nielson JE (1991) showed the efficacy of intravenous ketamine for prevention of severe hypotension during spinal anaesthesia. Their study compared circulatory changes in patients who received either fentanly or ketamine during spinal anaesthesia. In both groups the spinal anaesthesia caused a reduction in mean arterial pressure, but it was lower in fentanyl group than in ketamine group at all times. They concluded that during spinal anesthesia, patients can in part be kept hemodynamically stable by intravenous administration of ketamine.
2. / Tripathi M, Saxena GC (1992) conducted a double-blind clinical trial using a placebo and intravenous ketamine (0.5 mg/ Kg as bolus followed by 0.5 mg/ Kg/ hour) as infusion following spinal anesthesia. They concluded that low dose of ketamine in combination with diazepam significantly improves the quality of anesthesia, gives better cardiovascular stability without significant increase in complication rate and significantly improves patient acceptance for the technique.
3. / Lehot JJ, Bastieno, Pellisten FT, Villard J, Estanove S (1992) studied about vascular effects of ketamine during spinal anesthesia with diazepam and fentanyl. Ketamine leads to venous constriction and probably arterial dilation. The venous effects of ketamine could explain why it is usually well tolerated in hypovolemic states.
4 / Dewoolkar LV, Nishi Bhanti (1995) showed the efficacy of low dose intravenous ketamine for the prevention of spinal hypotension. They used intravenous ketamine in doses of 0.3 mg/Kg and repeated in doses of 0.15 mg/Kg every 15-30 minutes after spinal anesthesia with 0.5% bupivacaine heavy. They concluded that hypotension as a result of spinal anesthesia was much less as compared to a control group, which did not receive ketamine and was given only intravenous crystalloids. The requirement of intravenous crystalloid infusion was also markedly reduced in ketamine treated group.
5. / Leslie K, Sessler DI (1996) showed that reduction in the shivering threshold is proportional to spinal block height. They concluded that extensive spinal blockade impairs central thermoregulatory control more than less extensive blockade. Clinicians can thus anticipate more core hypothermia during extensive than during restricted spinal blockade.
6. / Ozkan T, Ozyuvaci EN et al (1996) used a sedation regimen of ketamine+ midazolam and fentanyl+midazolam in order to compare and see the hemodynamic effects of ketamine during spinal anesthesia. They observed that the use of ketamine and midazolam produced more stable hemodynamic parameters. They concluded that administration of ketamine during spinal anesthesia produces optimal sedation scores and eliminates the negative hemodynamic effects of spinal anesthesia.
6.3 / Objectives of the Study
To study the efficacy of low dose of intravenous ketamine for prevention of spinal hypotension.
7 / MATERIAL AND METHODS
7.1 / Source of Data:
Patients undergoing surgical and orthopaedic operations at Basaveshwar Teaching & General Hospital, Gulbarga.
7.2 / Methods of collection of data (including sampling procedure)
a) / Inclusion criteria: 100 patients in age group 18-70 years undergoing surgical and orthopaedic operations ASA Grade-I.
Cases where blood loss would be minimal and spinal hypotension would not be accounted due to blood loss were selected.
b) / Exclusion Criteria:
1. / Patient refusal.
2. / Infection at the site
3. / Bleeding diathesis
4. / Active neurologic disease
c) / Mode of Selection of cases: Random
d) / Allocation of Different Regimens:
1. / Premedication with injection diazepam 0.1 mg/ Kg and injection atropine 0.01 mg/Kg was given to all patients intravenously.
2. / Preloaded with intravenous crystalloids (Ringer lactate) 7 ml/ Kg over 20 minutes prior to anesthesia.
3. / IV Fluid infusion maintained to keep the blood pressure within 30% of the preoperative level.
4. / Group-1: Ketamine group – 0.3 mg/Kg intravenously and repeated every 15-20 minutes intraoperatively in doses of 0.15 mg/ Kg intravenously with 0.5% bupivacaine heavy for spinal anesthesia.
5. / Group-2: Only 0.5% bupivacaine heavy for spinal anesthesia.
e) / No. of cases in each group: 50
f) / Following parameters will be studied:
1. / Pulse rate
2. / Blood pressure
3. / Respiratory rate
4. / Intravenous fluid requirement.
g) / Data analysis: Statistical parameteric tests Fisher’s ‘f’ test, Bonferonni ‘T’ test, compared student ‘t’ test and Gaussian test (z).
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.
Routine blood and urine analysis, CXR, ECG in relevant cases.
7.4 / Has ethical clearance been obtained from your institution in case of 7.3?
Yes, ethical clearance has been taken from our Institution for this study.
8. / List of References:
1.  / Hemmingsen C, Neilsen JE. Intravenous ketamine for prevention of severe hypotension during spinal anesthesia. Acta Anaesthesiology Scand. 1991; 35(8): 755-7.
2.  / Tripathi M and Saxena GC. Low dose ketamine, an ideal supplementary anesthesia for spinal block. Journal of Indian Med Assoc. 1992 Mar; 90(3): 54-6.
3.  / Lehot JJ, Bastieno, Pelissien FT, Villard J, Estanove S. Vascular effects of ketamine during spinal anesthesia with diazepam and fentanyl. Ann Fr Anesth Reanim. 1992; 11(1): 8-11.
4.  / Nakamura K, Yokoyama K. The level of analgesia and changes in heart rate during spinal anesthesia. Masui. 1994 Feb; 43(2): 177-81.
5.  / Dewoolkar LV, Nishi Bhanti. Low dose of intravenous ketamine for prevention of spinal hypotension. Indian Journal of Anesthesia. 1995; 43: 393.
6.  / Leslie K, Sessler DI. Reduction in the shivering threshold in proportional to spinal block height. Anesthesiology. 1996 Jun; 84(6): 1327-31.
7.  / Ozkan T, Ozyuvaci EN, Talu KG et al. Effects of ketamine during spinal anesthesia. Br J of Anesth. 1996; 76(2): 73-74.
8.  / Sen S, Ozmert G, Aydin ON, Baran N, Caliskan E. Intravenous low dose of ketamine combined with intrathecal bupivacaine for cesarean section. Eur J Anesthesiol. 2005 Jul; 22(7): 518-23.
9.  / Park JW, Jung YH, Baek CW, Kang H, Cha SM. Effects of low dose ketamine on tourniquet induced hemodynamic responses. J. Int Med Res. 2007 Sep-Oct; 35(5): 600-8.
9. / Signature of Candidate / :
10. / Remarks of the Guide / :
11. / Name & Designation of (in block letters)
11.1 / Guide / Dr.BASAVARAJ V.MODI
M.D.
PROFESSOR & h.o.d.,
Dept. of ANAESTHESIOLOGY,
M.R.Medical College, Gulbarga
11.2 / Signature
11.3 / Co-guide / Dr.PARASHURAM R.JAJEE
M.D.
PROFESSOR,
Dept. of ANAESTHESIOLOGY,
M.R.Medical College, Gulbarga
11.4 / Signature
11.5 / Head of the Department / Dr.BASAVARAJ V.MODI
M.D.
PROFESSOR & h.o.d.,
Dept. of ANAESTHESIOLOGY,
M.R.Medical College, Gulbarga
11.6 / Signature
12. / 12.1 / Remarks of the Chairman & Principal
12.2 / Signature