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Combined Spinal-epidural Anesthesia for Cesarean Section Without Prophylactical Prehydration and Vasopressors

NCT03497364 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 930

Last updated 2020-11-18

No results posted yet for this study

Summary

Hypotension is a common complication in pregnant women after spinal anesthesia and related with the dose of local anesthetic. Injecting small dose local anesthetic into subarachnoid space can decrease the incidence of hypotension, but increase the risk of incomplete analgesia and muscle relaxation. The investigators hypothesize there is an optimal dose of bupivacaine and ropivacaine for subarachnoid injection in pregnant women, which can cause enough anesthesia and obviously decrease the incidence of hypotension without prophylactical prehydration and vasopressors. To verify this hypothesis, full-term pregnant women who were scheduled for elective cesarean section were recruited.Combined spinal-epidural anesthesia was performed for pregnant women after written informed consents. The dose of bupivacaine or ropivacaine is small and depends on height of pregnant women. The blood pressure, heart rate, respiratory rate, SpO2 and fetal heart rate were recorded and the blood flow volume of uterine artery was monitored The sensory and motor block were evaluated. After delivery, umbilical blood samples were taken for blood gas analysis. APGAR scores and neurological behavior of infant were evaluated and recorded. In the intraoperative period, side-effects and requirement for sedation, epidural injection or general anesthesia were noted. The quality of anaesthesia (judged by the anaesthetist), the quality of muscle relaxation (judged by the surgeon) and the degree of intraoperative comfort (judged by the patient) were recorded as excellent, good, fair or poor.

Conditions

  • Cesarean Section
  • Anesthesia, Spinal

Interventions

DRUG

bupivacaine

0.5 % bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection according to the height of subjects (1.7 ml for 173\~174cm, 1.65 ml for 170\~172cm, 1.6 ml for 168\~169cm, 1.55 ml for 165\~167cm, 1.5 ml for 163\~164cm, 1.45 ml for 160\~162cm, 1.4 ml for 158\~159cm, 1.35 ml for 155\~157cm, 1.3 ml for 153\~154cm, 1.25 ml for 150\~152cm, 1.2 ml for 148\~149cm)，1.15 ml for 145\~147cm).

DRUG

ropivacaine

0.5 % ropivacaine (1% ropivacaine (1.5 ml) + cerebrospinal fluid (1.5 ml)) was injection according to the height of subjects (2.300 ml for 173\~174cm, 2.225 ml for 170\~172cm, 2.15 0ml for 168\~169cm, 2.075 ml for 165\~167cm, 2.000 ml for 163\~164cm, 1.925 ml for 160\~162cm, 1.850 ml for 158\~159cm, 1.775 ml for 155\~157cm, 1.700 ml for 153\~154cm, 1.625 ml for 150\~152cm, 1.55 0ml for 148\~149cm, 1.475 ml for 145\~147cm)

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • Zhongjun Zhang, master · ShenZhen People's Hospital of Jinan University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03497364 on ClinicalTrials.gov