Comparison of dose of phenylephrine required to treat hypotension after spinal anaesthesia in parturients with normal and raised blood pressure
- Conditions
- Mild to moderate pre-eclampsia,
- Registration Number
- CTRI/2018/03/012890
- Lead Sponsor
- Guru Teg Bahadur Hospital
- Brief Summary
Post-spinalhypotension is a common side-effect of subarachnoid block. Vasopressors aregenerally used to correct this. Phenylephrine isthe vasopressor of choice for management of post-spinal hypotension in cesareansection. Since the risk of developing post-spinal hypotension is six times less inseverely preeclamptic parturients compared to healthy parturients, the dose ofphenylephrine required to treat hypotension in preeclamptics should also bedifferent from that of healthy parturients. However, data on the efficacy ofphenylephrine required to treat post-spinal hypotension in preeclamptic paturientsis lacking. Therefore this study is designed to evaluate and compare the efficacyof phenylephrine required to treat post-spinal hypotension in preeclamptic andnormotensive parturients.
**Aim:**
Toevaluate and compare the efficacy of phenylephrine required to treat post-spinalhypotension in preeclamptic and normotensive parturients scheduled for cesareansection under subarachnoid block.
**Objectives:**
Toevaluate and compare preeclamptic and normotensive parturientsscheduled forcesarean section under subarachnoid block with respect to:
1. Total dose of phenylephrine required to treat hypotension from the time of administration of SAB till baby delivery
2. Dose of phenylephrine required to treat the first episode of hypotension
3. Incidence of first bolus dose of phenylephrine being effective in treating hypotension
4. Total number of hypotensive episodes
5. Neonatal APGAR scores at 1st and 5th minute after birth and umbilical arterial cord blood pH
6. Maternal complications like bradycardia, rebound hypertension, nausea/vomiting etc.
**Methodology**
Afterobtaining due clearance from institutional ethics committee, a written,informed consent will be obtained from each participant prior to recruitingthem for the study. Previously healthy parturients with age group between 18and 40 years, with singleton term pregnancy will be included. Patients withhistory of diabetes, cardiovascular and cerebrovascular diseases, placentaprevia, abruptio placenta, fetal abnormalities, cord prolapse or nuchal cord,fetal malformations and those having any contraindication to SAB will beexcluded from the study.
Patientswith diagnosed preeclampsia (SBP ≥140 mm Hg or DBP ≥90 mm Hg after 20 weekgestation with proteinuria) will be included in group P and those with normalblood pressure will be included in group N. Blinding of the parturients togroup allocation would not be possible because group allocation would be doneon the basis of presence or absence of preecplampsia. The blood pressure whichwill be displayed on the monitor throughout the intraoperative period willpreclude blinding to the presence of preeclampsia.
Allpatients would receive aspiration prophylaxis. Routine monitors will beattached. Left uterine displacement will be given. Baseline HR, SBP, DBP, meanBP and SpO2 will be measured.Intravenous access will be secured and co-loadingwill be initiated. Under all aspetic and antiseptic precautions, SAB will begiven in sitting position. Hyperbaric bupivacaine (0.5%) 10 mg (height <150cm) or 12.5 mg (height >150 cm) will be injected slowly. Pulse rate and SBP,DBP and mean BP will be recorded at Ts and subsequently every minute till thedelivery of the baby. Further measurements of hemodynamic parameters will bedone every 5 min till the completion of the surgery. Level of block will benoted.Hypotension (MAP ≤70% of baseline value or SBP <100 mm Hg whicheveris higher; termed as the hypotensive value) will be treated with intravenousbolus of 50 µg phenylephrine. Further boluses of 50 µg phenylephrine will beadministered every minute till the BP is above the hypotensive value. This willbe considered as first hypotensive episode. If, after correction of first hypotensiveepisode, hypotension develops again, it will be considered as anotherhypotensive episode and will be treated similarly. Maternal side effects likebradycardia (HR <50/min), reactive hypertension (MAP >20% of baseline),nausea, vomiting etc. from the period of spinal injection to the delivery ofthe baby will be noted and treated accordingly. Umbilical artery blood sampleswill be obtained and sent for blood gas analysis. Neonatal APGAR score will berecorded at 1st and 5th min of birth.
The main observations related to efficacy of phenylephrine would be thetotal dose phenylephrine required to treat hypotension, the dose ofphenylephrine required to treat the first hypotensive episode and the incidenceof first bolus dose of phenylephrine being effective to manage the firsthypotensive episode.
Maternal adverse events would be measured in terms of incidence ofbradycardia and rebound hypertension. Neonatal outcome measures would include APGAR scores and umbilicalarterial pH.
Asancillary observations, the percentage of patients who develop post-spinalhypotension out of the total number of parturients recruited in that particulargroup will also be calculated.
**Sample Sizeand Statistical Analysis:**
Since there is lack of data on the effective dose of phenylephrine requiredto treat hypotension in preeclamptic parturients, this would be conducted as apilot study. A minimum of 60 parturients will be enrolled, till there is atotal of 30 parturients (normotensive and hypertensive each) who develophypotension requiring vasopressor administration for the management ofpost-spinal hypotension according to the criteria described in the study in eachof the group.
Comparison of qualitative data will be done using Chi-square test andFischer’s exact test and comparison of quantitative will be done using Student’st-test. A p-value <0.05 will be taken as statistically significant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 60
Previously healthy parturients with singleton term pregnancy.
History of diabetes, cardiovascular and cerebrovascular diseases, placenta previa, abruptio placenta, fetal abnormalities, cord prolapse or nuchal cord, fetal malformations and those having any contraindication to Spinal anaesthesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total dose phenylephrine required to treat hypotension Calculated once, after the delivery of the baby
- Secondary Outcome Measures
Name Time Method The dose of phenylephrine required to treat the first hypotensive episode Every 1 minute till the first hypotensive episode is treated successfully with phenylephrine
Trial Locations
- Locations (1)
GTB Hospital
🇮🇳Delhi, DELHI, India
GTB Hospital🇮🇳Delhi, DELHI, IndiaDr Rashmi SalhotraPrincipal investigator9911317334rashmichabra@yahoo.com