A Comparative Study of Fractionated Vs Single Dose Injection for Spinal Anesthesia During Caesarean Section in Patients With Pregnancy-Induced Hypertension
Sponsor study identifier
interventional
42
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
April 30, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)April 30, 2018
Actual (reported)May 31, 2018
Actual (reported)September 26, 2018
Actual (reported)October 3, 2018
Actual (reported)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
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
1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given
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
1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given
Cipto Mangunkusumo National Hospital
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
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.
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.
42 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2018
First Posted
October 3, 2018
Study Start
January 1, 2018
Actual (reported)PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
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.
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.
Primary Completion
April 30, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)Last Updated
February 5, 2019
Record last verified: 2019-02
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