Fractionated Vs Single Dose Injection for Spinal C-Section in Patients With Pregnancy-Induced Hypertension

University of Indonesia (UI)

Status: Completed

Conditions: Pregnancy Induced Hypertension

Treatments: Drug: Bupivacaine-fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03693638

IndonesiaUAnes024

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Single dose (SD)

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine-fentanyl

Drug: Bupivacaine-fentanyl

Fractionated dose (FD)

Active Comparator group

Description:

1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given

Treatment:

Drug: Bupivacaine-fentanyl

Drug: Bupivacaine-fentanyl