Comparison of Norepinephrine and crepe bandage in preventing spinal induced hypotension during cesarean section
- Conditions
- Term pregnancy, Elective LSCS
- Registration Number
- CTRI/2018/04/012917
- Lead Sponsor
- Mahatma Gandhi Medical College and Research Institute Pondicherry
- Brief Summary
Spinal anaesthesia(SA) is most preferred and followed mode of anaesthesia for Caesarean section because it has immediate onset, good muscle relaxation, reduce the bleeding, protection of airway reflex and avoidance of airway intervention , postoperative analgesia and early maternal baby bonding. However, SA is associated with maternal hypotension in 80–83 % of parturients. Hemodynamic control during Caesarean section under SA is therefore very important for the well-being of both the mother and the fetus. Among the non pharmacological methods, wrapping lower limbs with elastic crepe bandage showed positive results with minimal requirement of pharmacological intervention for hypotension. Pharmacological methods to treat hypotension include parentral vasopressors administration. Boluses of Ephedrine and Phenylephrine have been used through time. Norepinephrine acts on alpha 1 and alpha 2 adrenergic receptors and causes peripheral vasoconstriction. It is also a weak agonist at the beta adrenergic receptors. Hence there is a recent shift to prophylactic Nor-epinephrine infusion over the use of Phenylephrine and Ephedrine in prevention and treatment of spinal induced hypotension in caesarean section. This is a randomized, double – blinded triplearm trial that will be conducted in Mahatma Gandhi Medical College and Hospitalbetween January 2018- May 2019. Parturient who are posted for electivecaesarean section during this period will form the study population.Inclusion criteria will be as follows: Elective Caesarean delivery underspinal anaesthesia, American Society of Anaesthesiologists physical status 2,normotensive, term singleton pregnancy, baseline systolic BP 90-130 mm Hg, aged18 yrs and older ,weighing between 60-90 kgs . Exclusion criteria includespatient refusal, contraindications to spinal anaesthesia, hypertension,cardiovascular or cerebrovascular disease , fetal abnormalities and diabetes(excludinggestational diabetes) and difficult venous access. Writteninformed consent will be obtained from all the parturients. All partuients willreceive oral premedication with Tab. Ranitidine 150 mg and tab. metaclopromide 10mg on the morningof surgery. Inpreoperative area 15 minutes beforeshifting to operation theatre peripheral intravenous access will be obtained with 18G cannula and 10ml/kg ringerlactate will be infused. On arrival to the operation theatrestandard monitoring will be started whichinclude non- invasive blood pressure , ECG and pulse–oximetry. Three bloodpressure readings and heart rate will be measured at 3 minute interval with parturient in supine position with left lateral tiltachieved with the standard wedge under the right hip. The mean of the threerecordings will be recorded as the baseline value for maternal systolic bloodpressure and heart rate. A wide bore 18 G Intravenous catheter will beinserted on the other hand and keptflushed. Randomization is done by sealed envelope technique.One of the investigators who is not managingthe case will prepare the study solution for infusion which will be eithernorepinephrine 250mcg in 50 ml at a dilution of (5mcg/ml) in 50 ml syringe orsyringe containing 50 ml saline. The syringes will be labelled as studysolution and will be handed over to the attending anaesthesiologist. Legwrapping will be done in all parturients with leg elevated to 45 degree. To maintain blinding of all staffinvolved in patient care, after visual shielding between the head of the bedand the lower extremities leg wrapping will be performed by operationaltechnical assistants who is trained to do this procedure. In the leg wrappinggroup ( Group LW), elastic bandages (12 cm × 7m) will be applied tightly fromthe metatarsus to groin with overlap by one third between layers. In theControl group(Group C) and in the Norepinephrine group (Group NE ) , thebandage will be slackly laid around the legs. A chart containing infusion ratesof the study drug according to body weight will be provided in the operatingtheatre and the infusion rate will be set and kept ready for infusion.Subarachnoid block (SAB) will be performed withall patients in the left lateral position. After skin infiltration with 2%xylocaine, 25 G Quincke’s needle will be inserted at L2-3/L3-4 vertebralinter-space and once free flow of cerebrospinal fluid is obtained hyperbaricbupivacaine 0.5%, 9mg (1.8 ml) will be injected intrathecally. Patients willthen immediately be turned supine with left lateral tilt with wedge under righthip. Immediately following SAB, study drug infusion will be startedaccording to body weight using a syringe infusion pump ( BBraun). Group NE will receive Norepinephrine infusion at therate of 0.05 mcg/kg/min and the control(C) group and the leg wrapping(LW) groupwill receive saline infusion as per chart. The block height will be assessed byresponse to cold sensation using alcohol swab every minute until maximum block heightwas achieved. The block height of T6 will be considered appropriate. If sensoryblock is not achieved to T6 in five minutes the study will be terminated.Oxygen 6 L/min will be administered through polymask until delivery of thechild. Blood Pressure(BP) will measured at 1 min intervals beginningimmediately after spinal injection till baby delivery and at 5 minutes intervalafter baby delivery. Intravenous fluid will be infused at rate of10ml/kg/hr throughout the procedure bymeans of volumetric pump.The study infusion rate will be maintained till thedelivery of the baby according to the following protocol . If the SBPincreases 25% above the baseline, the infusion will be stopped. If the bloodpressure drops 20% below the baseline, 1ml bolus of the rescue drug (inj. Norepinephrine 5mcg ) will be administered and will be repeated after every BP recording till the blood pressureimproves to baseline value. If maternal HR is <50/min Inj. atropine 0.6 mg IV will given to treat bradycardia.Nausea and vomiting will be scored on a scale of 0-2 (0 =none, 1 = nauseawithout vomiting, 2 = vomiting). The maximum nausea and vomiting score beforedelivery of baby will be noted. As soonas baby is delivered,. Umbilicalarterial blood sample from a segment of clamped cord will be collected with 2ml heparinised syringe and APGAR scoresat 1 and 5 minutes will be noted and the study will be terminated. The datawill be recorded by the anaesthetist who is conducting the anaesthesia on thepreformed proforma sheet. After baby delivery Inj. Oxytocin 10 units will beinfused. Study infusion will be stopped and crepe bandage will be removedat the end of the surgery. Shivering ifpresent will be noted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 110
Parturient who are posted for elective caesarean section during the period of April 2018 to Nov 2019 will form the study population.
patient refusal, contraindications to spinal anaesthesia, hypertension, cardiovascular or cerebrovascular disease , fetal abnormalities and diabetes(excluding gestational diabetes) and difficult venous access.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of hypotension after spinal anesthesia and response to treatment Two minutes interval from spinal anesthesia till baby delivery and five minutes interval for one houe
- Secondary Outcome Measures
Name Time Method Umbilical cord ABG Immediately after baby delivery
Trial Locations
- Locations (1)
Mahatma Gandhi Medical College and Research Institute
🇮🇳Pondicherry, PONDICHERRY, India
Mahatma Gandhi Medical College and Research Institute🇮🇳Pondicherry, PONDICHERRY, IndiaDr RaniPPrincipal investigator9443116908anaesrani@gmail.com