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
CRIS Registration Number |
KCT0004783 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Konyang University Hospital |
Organization Type | Medical Institute |
Project ID | KYUH 2019-04-008 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Konyang University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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 |
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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)
Type of Primary Outcome | Safety | |
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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
Result Registered |
Yes
Results Upload |
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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 Statement | No |
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