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Comparison of effect of general versus spinal anesthesia on maternal and fetal outcomes: A retrospective study

Status Approved

  • First Submitted Date

    2020/02/14

  • Registered Date

    2020/03/03

  • Last Updated Date

    2020/03/04

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004783
    Unique Protocol ID KYUH 2019-04-008
    Public/Brief Title Comparison of general vs spinal anesthesia for c/s
    Scientific Title Comparison of effect of general versus spinal anesthesia on maternal and fetal outcomes: A retrospective study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KYUH 2019-04-008
    Approval Date 2019-06-18
    Institutional Review Board Name Konyang University Hospital IRB
    Institutional Review Board Address 158, Gwanjeodong-ro, Seo-gu, Daejeon
    Institutional Review Board Telephone 042-600-9057
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Young Seok Jee
    Title professor
    Telephone +82-42-600-9319
    Affiliation Konyang University Hospital
    Address 158 Gwanjeodong-ro, Seo-gu, Daejeon, Korea
    Contact Person for Public Queries
    Name Young Seok Jee
    Title professor
    Telephone +82-42-600-9319
    Affiliation Konyang University Hospital
    Address 158 Gwanjeodong-ro, Seo-gu, Daejeon, Korea
    Contact Person for Updating Information
    Name Young Seok Jee
    Title professor
    Telephone +82-42-600-9319
    Affiliation Konyang University Hospital
    Address 158 Gwanjeodong-ro, Seo-gu, Daejeon, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2019-06-19 Actual
    Target Number of Participant 300
    Primary Completion Date 2019-10-31 , Actual
    Study Completion Date 2019-12-25 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Konyang University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-06-19 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Konyang University Hospital
    Organization Type Medical Institute
    Project ID KYUH 2019-04-008
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Konyang University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Background: Although cesarean section is performed to ensure maternal and fetal wellbeing, few studies have compared the use of general vs. spinal anesthesia for this procedure in terms of maternal morbidity and neonatal wellbeing. This retrospective study was performed to compare maternal and fetal outcomes between general and spinal anesthesia based on maternal hemoglobin (g/dl), hematocrit (%), and postoperative hemodynamic parameters, and neonatal Apgar scores at 1 and 5 minutes.
    Methods: Data from 330 births between January 2016 and December 2018 were analyzed retrospectively. 43 cases excluded by exclusion criteria. 287 cases were divided into the general group (n = 141) or the spinal group (n = 146). 
    Results: There were no significant differences in the demographic characteristics of the two groups. However, in comparison to the spinal group, the general group had significantly lower postoperative Hb levels (g/dl) (9.7 ± 1.3 vs 10.7 ± 1.3, respectively, p < 0.001) and postoperative Hct levels (%) (31.4 ± 3.9 vs 34.2 ± 4.7, respectively, p < 0.001). Mean estimated blood loss (ml) was significantly lower in the spinal group than in the general group (856.7 ± 117.9 vs 819.9 ± 81.9, respectively, p < 0.001). 1 and 5 minute Apgar scores were significantly low in general group compared to spinal group(1 min Apgar score : 7.02 ± 1.3 vs 7.36 ± 0.88, respectively. p=0.037, 5 min Apgar score : 8.48 ± 0.95 vs 8.73 ± 0.53, respectively, p=0.048)
    Conclusions: General anesthesia causes more maternal blood loss than spinal anesthesia, and 1 and 5 min Apgar scores were significantly low in general than spinal anesthesia group for cesarean section.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Others  
    Intervention Description
    In the general anesthesia group, all patients were applied BIS monitoring and pre-oxygenation was performed using 100% oxygen for 3-5 min. Subsequently, 5 mg/kg of thiopental was used to induce anesthesia. Intravenous injection of 0.5 mg/kg rocuronium facilitated endotracheal intubation with Sellick maneuver to prevent aspiration. For all cases, controlled ventilation was established by setting the tidal volume to 8 ml/kg and respiration frequency 12-14 per minute. Anesthesia was maintained with a mixture of 1.5-2.0 vol% sevoflurane and 50% nitrous oxide in oxygen. If a maintenance dose was required, 0.15 mg/kg of rocuronium was added intravenously. At the end of the surgery, the residual neuromuscular block was antagonized with pyridostigmine (0.2mg/kg) and glycopyrrolate (4 μg/kg). The patients were extubated when they were fully awaked to prevent aspiration.
    The spinal anesthesia patients were punctured via L2/3 or L3/4 with 25G pencil point needle (Sprotte®, Pajunk, Germany) on left lateral decubitus position and supplied O2 6L/min via oxygen mask. . After confirming clear free flow of CSF, heavy bupivacaine 0.5% 9-10mg with fentanyl 10mcg was slowly injected. And then patients were changed to a fully supine position and tilted 15 degree left downward to prevent supine hypotensive syndrome. The sensory block level was determined by means of a cold test, as a dermatome level. When the sensory block reached a sufficient level (T4-T5), the operation was started. At the same time, phenylephrine 10ml/hr was continuously infused in order to prevent arterial hypotension. If hypotension persisted, 0.1mg phenylephrine was injected bolus or continuous injection rate was increased to 20ml/hr. Meanwhile, if hypertension occurred, continuous injection rate was decreased to 5ml/hr or stopped. After the newborn was delivered, the patients were sedated with intravenous midazolam when required.
    Number of Arms 2
    Arm 1

    Arm Label

    spinal anesthesia group for elective cesarean section

    Target Number of Participant

    150

    Arm Type

    Experimental

    Arm Description

    The spinal anesthesia patients were punctured via L2/3 or L3/4 with 25G pencil point needle (Sprotte®, Pajunk, Germany) on left lateral decubitus position and supplied O2 6L/min via oxygen mask. . After confirming clear free flow of CSF, heavy bupivacaine 0.5% 9-10mg with fentanyl 10mcg was slowly injected. And then patients were changed to a fully supine position and tilted 15 degree left downward to prevent supine hypotensive syndrome. The sensory block level was determined by means of a cold test, as a dermatome level. When the sensory block reached a sufficient level (T4-T5), the operation was started. At the same time, phenylephrine 10ml/hr was continuously infused in order to prevent arterial hypotension. If hypotension persisted, 0.1mg phenylephrine was injected bolus or continuous injection rate was increased to 20ml/hr. Meanwhile, if hypertension occurred, continuous injection rate was decreased to 5ml/hr or stopped. After the newborn was delivered, the patients were sedated with intravenous midazolam when required.
    Arm 2

    Arm Label

    general anesthesia group for elective cesarean section

    Target Number of Participant

    150

    Arm Type

    Active comparator

    Arm Description

    In the general anesthesia group, all patients were applied BIS monitoring and pre-oxygenation was performed using 100% oxygen for 3-5 min. Subsequently, 5 mg/kg of thiopental was used to induce anesthesia. Intravenous injection of 0.5 mg/kg rocuronium facilitated endotracheal intubation with Sellick maneuver to prevent aspiration. For all cases, controlled ventilation was established by setting the tidal volume to 8 ml/kg and respiration frequency 12-14 per minute. Anesthesia was maintained with a mixture of 1.5-2.0 vol% sevoflurane and 50% nitrous oxide in oxygen. If a maintenance dose was required, 0.15 mg/kg of rocuronium was added intravenously. At the end of the surgery, the residual neuromuscular block was antagonized with pyridostigmine (0.2mg/kg) and glycopyrrolate (4 μg/kg). The patients were extubated when they were fully awaked to prevent aspiration.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (O00-O99)Pregnancy, childbirth and the puerperium 
       (O82.9)Delivery by caesarean section, unspecified 

    Singleton pregnacies were scheduled elective cesarean sections
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~49Year

    Description

    Singleton pregnant women were scheduled elective cesarean sections the physical condition classified as 1 or 2 according to the American Society of Anesthesiologists (ASA) classification.
    Exclusion Criteria
    Exclusion criteria were cases of emergency or epidural anesthesia or conversion from spinal to general anesthesia, cases expecting bleeding such as placenta previa, coagulopathy.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Safety
    Primary Outcome(s) 1
    Outcome
    pre and postoperative Hb (g/dL) and Hct(%), estimated blood loss (EBL),
    Timepoint
    preoperative day, postoperative 1day and 3day
    Secondary Outcome(s) 1
    Outcome
    1 and 5 minute Apgar score
    Timepoint
    after cesarean delivery
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Results Upload
    Final Enrollment Number 287
    Number of Publication 0
    Results Upload mauscript 1 version_4_final.docx
    Date of Posting Results 2020/03/03
    Protocol URL or File Upload mauscript 1 version_4_final1.docx
    Brief Summary
    There were no significant differences in demographic characteristics except gravity (3[2-4] vs 2[1-3], p= 0.031), surgical time (min) (56.9 ± 13.1 vs 53.2 ± 11.1, p= 0.011) general vs spinal group, respectively.
    Maternal and fetal parameters are described in table 2. Pre and postoperative heart rates (rates/min) was compared between two groups. There was a significant difference of preoperative heart rates (rates/min) between two groups (81.6 ± 12.6 vs 85.6 ± 13.9, general vs spinal group, respectively. p= 0.011). Postoperative heart rate was significantly increased in general compared to spinal group (93.2 ± 16.8 vs 71.0 ± 12.7, respectively. p<0.001). 
    Mean preoperative Hb (g/dL), Hct (%) level showed no significant differences between two groups. However, postoperative Hb level was significantly lower in general compare to spinal group (9.7 ± 1.3 vs 10.7 ± 1.3, p < 0.001), respectively. Similarly mean postoperative Hct (%) level was also significantly lower in general compare to spinal group (31.4 ± 3.9 vs 34.2 ± 4.7, respectively. p < 0.001),. Mean difference between preoperative Hb and postoperative Hb showed no significant differences between two groups, but mean difference between preoperative Hct and postoperative Hct was significantly greater in general than spinal group (4.8 ± 3.4 vs 2.3 ± 3.9, p < 0.001, respectively).
    Mean EBL (ml) was significantly lower in spinal than general group (856.7 ± 117.9 vs 819.9 ± 81.9, respectively. p < 0.001). There was no significant difference of transfusion rate, a ratio of transfused subjects to total subject, between two groups. (Table 2) 
    1 min Apgar scores were significantly low in general compared to spinal group (7.02 ± 1.3 vs 7.36 ± 0.88, respectively. p=0.037). 5min Apgar scores were also significantly low in general compared to spinal group (8.48 ± 0.95 vs 8.73 ± 0.53, respectively, p=0.048). However, newborns of 1 min Apgar scores <7 were no significant difference between two groups, but newborns of 5 min Apgar scores <7 were significantly more in general than spinal group (6/141(4.3%) vs 0/146(0%), respectively. p=0.012). (Table 2)
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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