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

NCT03497364 | Unknown

• 1 other identifier: SZY-00251
• Study Type: interventional
• Target: 930
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cesarean Section; Hypotension; Combined spinal-epidural anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension after anesthesia

  Hypotension after anesthesia expressed in number of patients with one or more episodes of hypotension (Systolic blood pressure \< 90 mmHg or 70% of baseline value) up to fetal delivery.

  delivery

Study Arms (3)

Bupivacaine group

EXPERIMENTAL

Pregnant women received combined spinal-epidural anesthesia by injecting bupivacaine. The dose of bupivacaine depended on height of subjects.

Drug: bupivacaine

Ropivacaine group

EXPERIMENTAL

Pregnant women received combined spinal-epidural anesthesia by injecting ropivacaine. The dose of ropivacaine depended on height of subjects).

Drug: ropivacaine

Control group

NO INTERVENTION

Pregnant women received combined spinal-epidural anesthesia by injecting bupivacaine. 2ml bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection for all subjects.

Interventions

bupivacaine DRUG

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).

Bupivacaine group

ropivacaine DRUG

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)

Ropivacaine group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women who were scheduled for cesarean section.

You may not qualify if:

• Women with cardiovascular disease, fetal abnormalities, placental abruption, placenta previa, placental abnormalities, sidewall placenta, abnormal fetal heart rate and spinal anesthesia contraindications.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

ShenZhen People's Hospital of Jinan University

Shenzhen, Guangdong, 518020, China

RECRUITING

Related Publications (3)

• Huang J, Wen G, Huang Q, Huang B. Anesthesia characteristic of an algorithm of bupivacaine dose based on height in caesarean section under spinal anesthesia: a retrospective cohort study. BMC Anesthesiol. 2023 May 2;23(1):146. doi: 10.1186/s12871-023-02113-0.

  PMID: 37131191 DERIVED

• Huang Q, Wen G, Hai C, Zheng Z, Li Y, Huang Z, Huang B. A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial. Front Med (Lausanne). 2022 Jun 10;9:858115. doi: 10.3389/fmed.2022.858115. eCollection 2022.

  PMID: 35755061 DERIVED

• Huang B, Huang Q, Hai C, Zheng Z, Li Y, Zhang Z. Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial. BMJ Open. 2019 May 16;9(5):e024912. doi: 10.1136/bmjopen-2018-024912.

  PMID: 31101694 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Bupivacaine; Ropivacaine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Zhongjun Zhang, master

  ShenZhen People's Hospital of Jinan University

  STUDY DIRECTOR

Central Study Contacts

Bowan Huang, docter

CONTACT

+86 755-25533018; 285021731@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 13, 2018
• Study Start: May 1, 2018
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)