Clinical Trials Logo

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03693638
Study type Interventional
Source Indonesia University
Status Completed
Phase N/A
Start date January 1, 2018
Completion date May 31, 2018

See also
  Status Clinical Trial Phase
Completed NCT01682304 - Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension N/A
Suspended NCT01519297 - Preeclampsia: A Marker for Future Cardiovascular Risk in Women N/A
Recruiting NCT02016638 - Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes N/A
Withdrawn NCT00293735 - Labetalol Versus Magnesium Sulfate (MgSO4) for the Prevention of Eclampsia Trial Phase 2/Phase 3
Not yet recruiting NCT02007837 - Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial Phase 3
Completed NCT02229526 - Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP') N/A
Completed NCT02213094 - Phase I Study of Nicotinamide for Early Onset Preeclampsia Phase 1
Completed NCT02468310 - Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana N/A
Recruiting NCT02419898 - Oxfordshire Women and Their Children's Health