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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose (SD) | Active Comparator | 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) | Active Comparator | 1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine-fentanyl | Drug | 2,5 ml total anesthetic drug dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of mean arterial pressure (MAP) | drop of blood pressure more than 20% of baseline value, and were treated with ephedrine 5 - 10 mg which could be repeated if necessary | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo National Hospital | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17048420 | Background | Chumpathong S, Chinachoti T, Visalyaputra S, Himmunngan T. Incidence and risk factors of hypotension during spinal anesthesia for cesarean section at Siriraj Hospital. J Med Assoc Thai. 2006 Aug;89(8):1127-32. | |
| 19218369 | Background | Sharwood-Smith G, Drummond GB. Hypotension in obstetric spinal anaesthesia: a lesson from pre-eclampsia. Br J Anaesth. 2009 Mar;102(3):291-4. doi: 10.1093/bja/aep003. No abstract available. |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| Bupivacaine-fentanyl | Drug | 1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given |
|
| 28216705 | Background | Badheka JP, Oza VP, Vyas A, Baria D, Nehra P, Babu T. Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing elective caesarean section: A randomised, double-blind study. Indian J Anaesth. 2017 Jan;61(1):55-60. doi: 10.4103/0019-5049.198390. |
| 15220175 | Background | Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. No abstract available. |
| 30881909 | Derived | Nugroho AM, Sugiarto A, Chandra S, Lembahmanah L, Septica RI, Yuneva A. A Comparative Study of Fractionated Versus Single Dose Injection for Spinal Anesthesia During Cesarean Section in Patients with Pregnancy-Induced Hypertension. Anesth Pain Med. 2019 Feb 6;9(1):e85115. doi: 10.5812/aapm-85115. eCollection 2019 Feb. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |