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

Pregnancy Induced Hypertension Clinical Trial

Official title:

A Comparative Study of Fractionated Vs Single Dose Injection for Spinal Anesthesia During Caesarean Section in Patients With Pregnancy-Induced Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693638
• Other study ID #: IndonesiaUAnes024
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: May 31, 2018

Study information

• Verified date: February 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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 information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced
• Pregnancy Induced Hypertension

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (4)

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. — View Citation

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. Erratum in: J Med Assoc Thai. 2006 Oct;89(10):1804. — View Citation

Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. Epub 2004 Jun 25. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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