Clinical trial NCT05475990: Comparison of Hydroxyethyl Starch and Crystalloid Coload Combined With Norepinephrine Infusion for Hypotension
Official title: Comparison of 6% Hydroxyethyl Starch (130/0.4) and Crystalloid Coload Combined With Prophylactic Norepinephrine Infusion for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect
Keywords: Crystalloid
Hydroxyethyl starch 130/0.4
Postspinal anesthesia hypotension
Cesarean section
Norepinephrine
Coload
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

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. Colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Eligibility criteria: Inclusion Criteria:

* 18-40 years
* Primipara or multipara
* Singleton pregnancy ≥ 37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for elective 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 ≥ 160mmHg
* Hemoglobin \< 7g/dl
* Coagulation or renal function disorders
* Known allergy to hydroxyethyl starch
* Fetal distress, or known fetal developmental anomaly

Primary outcomes:
measure: ED 50 and ED 90
timeFrame: 1-15 minutes after spinal anesthesia
Secondary outcomes:
measure: The incidence of post-spinal anesthesia hypotension
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of severe post-spinal anesthesia hypotension.
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of bradycardia.
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of nausea and vomiting.
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of hypertension.
timeFrame: 1-15 minutes after spinal anesthesia
measure: pH
timeFrame: Immediately after delivery
measure: Partial pressure of oxygen (PO2)
timeFrame: Immediately after delivery
measure: Base excess (BE)
timeFrame: Immediately after delivery
measure: APGAR score
timeFrame: 1 min after delivery
measure: APGAR score
timeFrame: 5 min after delivery
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Yi Chen, M.D.
role: STUDY_CHAIR
affiliation: The People's Hospital of Nanchuan
name: Xiangzhao Xu, M.D.; Ph. D
role: STUDY_CHAIR
References: