Pregnancy Induced HypertensionNCT03693638
Fractionated Vs Single Dose Injection for Spinal C-Section in Patients With Pregnancy-Induced Hypertension
A study testing Bupivacaine-fentanyl in people with Pregnancy Induced Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy Induced Hypertension
- What is being tested?
- Bupivacaine-fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2018to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- chronic hypertension
- eclampsia
- pulmonary edema
- cerebrovascular diseases
- type-2 diabetes mellitus and gestational diabetes
- placental abruption/previa/accreta
Show all 11Show fewer
- umbilical cord prolapse
- gestational age <34 weeks
- estimated fetal weight <=2.300 gram and >=4.000 gram
- polyhydramnios
- fetal distress
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: A Comparative Study of Fractionated Vs Single Dose Injection for Spinal Anesthesia During Caesarean Section in Patients With Pregnancy-Induced Hypertension
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
Read the 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
- Being tested
- Bupivacaine-fentanyl
- Keywords
- spinal anesthesia, pregnancy-induced hypertension, Cesarean section
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-fentanylDrug
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-fentanylDrug
1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bupivacaine-fentanyl |
| 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 Receives: Drug: Bupivacaine-fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Jan 2018
- Primary completion30 Apr 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Induced HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfan Mahdi Nugroho, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693638
- Sponsor's protocol ID
- IndonesiaUAnes024
- Status last verified
- Feb 2019
- First submitted
- 26 Sep 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17048420Sharwood-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.
PubMed 19218369Badheka 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.
PubMed 28216705Hocking 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.
PubMed 15220175Nugroho 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.
PubMed 30881909
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Fractionated Vs Single Dose Injection for Spinal Anesthesia During Caesarean Section in Patients With Pregnancy-Induced Hypertension
- ClinicalTrials.gov ID
- NCT03693638
- Acronym / sponsor ID
- IndonesiaUAnes024
- Conditions
- Pregnancy Induced Hypertension
- Keywords
- spinal anesthesia, pregnancy-induced hypertension, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose (SD) | Active comparator | Drug: Bupivacaine-fentanyl2,5 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 | Drug: Bupivacaine-fentanyl1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- with hypertension in pregnancy (gestational hypertension or preeclampsia)
- ASA II-III
- aged 18 - 40 years
- BMI 18.5 - 35 kg/m2
- singleton pregnancy
Key exclusion criteria (11 listed)
- chronic hypertension
- eclampsia
- pulmonary edema
- cerebrovascular diseases
- type-2 diabetes mellitus and gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine-fentanyl2,5 ml total anesthetic drug dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds | Drug | Single dose (SD) |
| Bupivacaine-fentanyl1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given | Drug | Fractionated dose (FD) |
Primary outcome
Change of mean arterial pressure (MAP)
Time frame: 15 minutes
drop of blood pressure more than 20% of baseline value, and were treated with ephedrine 5 - 10 mg which could be repeated if necessary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Background: PubMed 17048420Chumpathong 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.
- Background: PubMed 19218369Sharwood-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.
- Background: PubMed 28216705Badheka 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.
- Background: PubMed 15220175Hocking 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.
- Derived from this study: PubMed 30881909Nugroho 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pregnancy Induced Hypertension
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
RecruitingPhase 4
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingPhase 2
Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine-fentanyl in people with Pregnancy Induced Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mean arterial pressure (MAP) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03693638, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.