A Phase 4 interventional study of Phenylephrine hydrochloride infusion in Hypotension After Spinal Anesthesia, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Peking University People's Hospital · Phase 4, Interventional, and Prevention
The purpose of this study is to determine the 50% and 90% effective doses (ED50 and ED90) of prophylactic phenylephrine infusion for preventing spinal anesthesia-induced hypotension during elective cesarean delivery, in the supine position and in the left-lateral-tilt 15° position, respectively. Two hundred parturients with singleton term pregnancies will be randomized 1:1 to the supine group or the left-tilt 15° group, and within each position 1:1:1:1 to one of four fixed phenylephrine infusion rates (0.2, 0.4, 0.6, or 0.8 μg/kg/min; 25 per group), with the rate allocation masked by concentration blinding (identical pump rate, different solution concentrations). Spinal anesthesia consists of hyperbaric bupivacaine 12 mg plus morphine 0.15 mg. The primary outcome is the incidence of hypotension (systolic blood pressure \< 80% of baseline or \< 90 mmHg) from completion of the intrathecal injection to delivery. ED50 and ED90 will be estimated by probit regression within each position.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 200 is above the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the supine position (maintained from completion of spinal anesthesia until delivery) receiving prophylactic phenylephrine infusion 0.2 μg/kg/min (pump rate 0.6 mL/kg/h, concentration-blinded solution 20 μg/mL) from completion of spinal anesthesia until delivery.
Drug: Phenylephrine hydrochloride infusion
Supine position as Arm 1; phenylephrine infusion 0.4 μg/kg/min (concentration-blinded solution 40 μg/mL).
Drug: Phenylephrine hydrochloride infusion
Supine position as Arm 1; phenylephrine infusion 0.6 μg/kg/min (concentration-blinded solution 60 μg/mL).
Drug: Phenylephrine hydrochloride infusion
Supine position as Arm 1; phenylephrine infusion 0.8 μg/kg/min (concentration-blinded solution 80 μg/mL).
Drug: Phenylephrine hydrochloride infusion
Participants in the left-lateral-tilt 15° position (sponge wedge 7.5 × 28 × 50 cm under the thoracolumbar region, maintained from completion of spinal anesthesia until delivery) receiving prophylactic phenylephrine infusion 0.2 μg/kg/min (pump rate 0.6 mL/kg/h, concentration-blinded solution 20 μg/mL).
Drug: Phenylephrine hydrochloride infusion
Left-tilt 15° position as Arm 5; phenylephrine infusion 0.4 μg/kg/min (concentration-blinded solution 40 μg/mL).
Drug: Phenylephrine hydrochloride infusion
Left-tilt 15° position as Arm 5; phenylephrine infusion 0.6 μg/kg/min (concentration-blinded solution 60 μg/mL).
Drug: Phenylephrine hydrochloride infusion
Left-tilt 15° position as Arm 5; phenylephrine infusion 0.8 μg/kg/min (concentration-blinded solution 80 μg/mL).
Drug: Phenylephrine hydrochloride infusion
Prophylactic fixed-rate IV infusion (pump rate 0.6 mL/kg/h, concentration-blinded), from completion of spinal anesthesia until delivery
hypotension incidence of hypotension from completion of intrathecal injection to delivery of the infant
Hypotension defined as systolic blood pressure \< 80% of baseline (measured in the assigned study position) or \< 90 mmHg
Time frame: From completion of spinal anesthesia to fetal delivery
Umbilical artery and umbilical vein blood gas values
Umbilical artery and umbilical vein blood gas values (pH, PCO2, PO2, base excess, lactate)
Time frame: At delivery
Apgar scores at 1 and 5 minutes after delivery
Time frame: From fetal delivery to 5 minutes after delivery
Time to first rescue vasopressor
Time frame: From completion of intrathecal injection to delivery
Serial systolic blood pressure values within 12 minutes after intrathecal injection
Time frame: From completion of spinal anesthesia to 12 minutes after completion of spinal anesthesia
Incidence of hypertension before delivery
Incidence of hypertension (systolic blood pressure ≥ 120% of baseline) before delivery
Time frame: From completion of intrathecal injection to delivery
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2027, 4 months later.
Of 60 non-industry phase 4 interventional studies under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 4 months is below that.
Counting every sponsor, half of 61 studies reached it within 12 months; a quarter within 5 and three quarters within 20.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Phenylephrine
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