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

NCT ID: NCT03693638

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-05-31

Brief 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

Detailed 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.

Conditions

Pregnancy Induced Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single dose (SD)

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine-fentanyl

Intervention Type: 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

Fractionated dose (FD)

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine-fentanyl

Intervention Type: DRUG

1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given

Interventions

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

Intervention Type: DRUG

Bupivacaine-fentanyl

1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Alfan Mahdi Nugroho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cipto Mangunkusumo National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

References

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.

Reference Type: BACKGROUND

PMID: 17048420 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19218369 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28216705 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15220175 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30881909 (View on PubMed)

Other Identifiers

IndonesiaUAnes024

Identifier Type: -

Identifier Source: org_study_id