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

Primary Purpose

Pregnancy Induced Hypertension

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Bupivacaine-fentanyl
Bupivacaine-fentanyl
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Induced Hypertension focused on measuring spinal anesthesia, pregnancy-induced hypertension, Cesarean section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cipto Mangunkusumo National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single dose (SD)

Fractionated dose (FD)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 26, 2018
Last Updated
February 2, 2019
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT03693638
Brief Title
Fractionated Vs Single Dose Injection for Spinal C-Section in Patients With Pregnancy-Induced Hypertension
Official Title
A Comparative Study of Fractionated Vs Single Dose Injection for Spinal Anesthesia During Caesarean Section in Patients With Pregnancy-Induced Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Induced Hypertension
Keywords
spinal anesthesia, pregnancy-induced hypertension, Cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single dose (SD)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Fractionated dose (FD)
Arm Type
Active Comparator
Arm Description
1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-fentanyl
Intervention Description
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
Intervention Name(s)
Bupivacaine-fentanyl
Intervention Description
1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given
Primary Outcome Measure Information:
Title
Change of mean arterial pressure (MAP)
Description
drop of blood pressure more than 20% of baseline value, and were treated with ephedrine 5 - 10 mg which could be repeated if necessary
Time Frame
15 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cipto Mangunkusumo National Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17048420
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.
Results Reference
background
PubMed Identifier
19218369
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. No abstract available.
Results Reference
background
PubMed Identifier
28216705
Citation
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.
Results Reference
background
PubMed Identifier
15220175
Citation
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.
Results Reference
background
PubMed Identifier
30881909
Citation
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.
Results Reference
derived

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

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