Fractionated Vs Single Dose Injection for Spinal C-Section in Patients With Pregnancy-Induced Hypertension
- Conditions
- Pregnancy Induced Hypertension
- Interventions
- Drug: Bupivacaine-fentanyl
- Registration Number
- NCT03693638
- Lead Sponsor
- Indonesia University
- Brief Summary
The aim of this study was to compare haemodynamic changes, total dose of ephedrin requirement, and level of sensory blockade between fractionated dose and single dose spinal anesthesia injection in obstetric patients with pregnancy-induced hypertension who underwent Caesarean section
- Detailed Description
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups; single dose (SD) and fractionated dose (FD). All subjects will receive spinal anesthesia with 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. After IV cannulas (18 - 20 G) were properly placed, premedication with intravenous (IV) ranitidine 50 mg and metoclopramide 10 mg were given. Additional IV access was added if MgSO4 must been continuously administered intravenously perioperatively. Standard monitor device were placed after patients had been transferred to operating room. Additional premedication such as intravenous midazolam 0.02 mg/BW or fentanyl 1 mcg/BW were given if the patients were anxious or in pain. Baseline haemodynamic measurement was done two minutes after premedication. Spinal anesthesia was performed while patients in sitting position at L3-4 or L4-5 level with median or paramedian approach, with total dose 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. After skin wheal of lidocaine at the intended spinous interspace were placed, spinal needle (SpinocanR, B Braun, 27 G) were inserted and advanced until subarachnoid space were reached. In group FD, 1,5 ml of total dose followed by 1 ml remaining dose after 90 s interval were given. In SD group, 2,5 ml total dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds. If there were more than three injection attempts, the patients were excluded from the study. Co-loading 5 - 10 ml/kg ringer lactate in 20 minutes were given for all subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
- with hypertension in pregnancy (gestational hypertension or preeclampsia)
- ASA II-III
- aged 18 - 40 years
- BMI 18.5 - 35 kg/m2
- singleton pregnancy
- would undergo spinal anesthesia for emergency or semi-emergency caesarean section
- chronic hypertension
- eclampsia
- pulmonary edema
- cerebrovascular diseases
- type-2 diabetes mellitus and gestational diabetes
- placental abruption/previa/accreta
- umbilical cord prolapse
- gestational age <34 weeks
- estimated fetal weight <=2.300 gram and >=4.000 gram
- polyhydramnios
- fetal distress
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single dose (SD) Bupivacaine-fentanyl 2,5 ml total anesthetic drug dose (Bupivacaine-fentanyl) were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds Fractionated dose (FD) Bupivacaine-fentanyl 1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given
- Primary Outcome Measures
Name Time Method Change of mean arterial pressure (MAP) 15 minutes drop of blood pressure more than 20% of baseline value, and were treated with ephedrine 5 - 10 mg which could be repeated if necessary
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cipto Mangunkusumo National Hospital
🇮🇩Jakarta Pusat, DKI Jakarta, Indonesia