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NCT06151522 | NOT YET RECRUITING | Adverse Effect

90% Effective Dose of Phenylephrine Infusions Under Intensive and Standard Treatment
Sponsor:

General Hospital of Ningxia Medical University

Brief Summary:

The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment during cesarean section

Condition or disease

Adverse Effect

Intervention/treatment

Alpha-Agonist

α-adrenergic receptor agonist

Phase

NA

Detailed Description:

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment during cesarean section.

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 90% Effective Dose of Phenylephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive and Standard Treatment During Cesarean Section
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 18-45 years
  • * Primipara or multipara
  • * Singleton pregnancy ≥37 weeks
  • * American Society of Anesthesiologists physical status classification I to II
  • * Scheduled for cesarean section under spinal anesthesia
Exclusion Criteria
  • * Body height \< 150 cm
  • * Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • * Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
  • * Hemoglobin \< 7g/dl
90% Effective Dose of Phenylephrine Infusions Under Intensive and Standard Treatment

Location Details

NCT06151522

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