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HypotensionNCT02542748

Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients

A study testing Norepinephrine and Ephedrine in people with Hypotension and Obstetrical Complication of Anesthesia, run by Air Force Military Medical University, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be used to treat hypotension but lead to lower fetal pH as well. This study is to compare the effects of norepinephrine and ephedrine on hypotension in parturients. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Norepinephrine and Ephedrine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
5 Oct 2015to Jun 2016
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients scheduled for elective cesarean section

Who cannot join

  • Patients with severe pre-eclampsia
  • Patients with contraindications for spinal anesthesia
  • Patients with multiple pregnancy
  • Patients with gestation <38w

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital,Fourth Military Medical University

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients Undergoing Cesarean Section: a Randomized Double Blinded Controlled Study

Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be used to treat hypotension but lead to lower fetal pH as well. This study is to compare the effects of norepinephrine and ephedrine on hypotension in parturients.

Read the detailed description

Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. Ephedrine could be used to treat hypotension but lead to lower fetal pH, which may be related to worse fetal outcome.Norepinephrine could improve the hypotension to the same extent as phenylephrine. In this study, we tend to compare the effects of norepinephrine and ephedrine on hypotension in parturients and on fetal acid status.

Being tested
Norepinephrine, Ephedrine
Keywords
norepinephrine, ephedrine
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NorepinephrineDrug

    Also called vasoactive agents

    norepinephrine injection

  • EphedrineDrug

    Also called vasoactive agents

    Ephedrine injection

Study groups in NCT02542748
Study groupRoleWhat they receive
norepinephrineExperimentalnorepinephrine is injected after spinal anesthesia
Receives: Drug: Norepinephrine
ephedrineOtherephedrine is injected after spinal anesthesia
Receives: Drug: Ephedrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of hypotension

    Measured: from immediately after spinal anesthesia to 30min after spinal anesthesia

Secondary outcomes (13)

  1. pH value of fetal arterial blood

    Measured: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  2. incidence of nausea and vomiting

    Measured: from immediately after spinal anesthesia to 30min after spinal anesthesia

  3. incidence of dizzy

    Measured: from immediately after spinal anesthesia to 30min after spinal anesthesia

  4. incidence of chest congestion

    Measured: from immediately after spinal anesthesia to 30min after spinal anesthesia

  5. fetal arterial partial pressure of oxygen

    Measured: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  6. arterial base excess of fetal arterial blood

    Measured: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  7. lowest neonatal cerebral oxygen saturation

    Measured: from clamp of the umbilical cord to 10 min later, 10min in total

  8. lactate level of fetal arterial blood

    Measured: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  9. number of rescue vasoactive agent

    Measured: from immediately after spinal anesthesia to 30min after spinal anesthesia

  10. incidence of bradycardia

    Measured: from immediately after spinal anesthesia to 30min after spinal anesthesia

  11. incidence of dyspnea

    Measured: from immediately after spinal anesthesia to 30min after spinal anesthesia

  12. Apgar scores of the neonates

    The Apgar score is a method to quickly summarize the health of newborn children.It is determined by evaluating the newborn baby on five simple criteria(Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts

    Measured: from clamp of umbilical cord to 1min after clamping

  13. Apgar scores of the neonates

    The Apgar score is a method to quickly summarize the health of newborn children.It is determined by evaluating the newborn baby on five simple criteria(Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts

    Measured: from clamp of umbilical cord to 5min after clamping

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2015 (estimated)
  2. Study start5 Oct 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02542748
Sponsor's protocol ID
XJH-A-2015-5-5-01
Status last verified
Jan 2019
First submitted
3 Sep 2015
Last updated
15 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available.

    PubMed 25654435

  • Moslemi F, Rasooli S. Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial. Iran J Med Sci. 2015 Jan;40(1):19-26.

    PubMed 25649721

  • Mitra JK, Roy J, Bhattacharyya P, Yunus M, Lyngdoh NM. Changing trends in the management of hypotension following spinal anesthesia in cesarean section. J Postgrad Med. 2013 Apr-Jun;59(2):121-6. doi: 10.4103/0022-3859.113840.

    PubMed 23793313

  • Fan QQ, Wang YH, Fu JW, Dong HL, Yang MP, Liu DD, Jiang XF, Wu ZX, Xiong LZ, Lu ZH. Comparison of two vasopressor protocols for preventing hypotension post-spinal anesthesia during cesarean section: a randomized controlled trial. Chin Med J (Engl). 2021 Mar 4;134(7):792-799. doi: 10.1097/CM9.0000000000001404.

    PubMed 33661141

Questions about this trial

What is this clinical trial studying?

A study testing Norepinephrine and Ephedrine in people with Hypotension and Obstetrical Complication of Anesthesia, run by Air Force Military Medical University, China at 1 site in China.

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 1 inclusion and 4 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 15 Jan 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 China. 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?

incidence of hypotension (time frame: from immediately after spinal anesthesia to 30min after spinal anesthesia). 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 NCT02542748, which also lists 4 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 15 Jan 2019.

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