Status Approved
First Submitted Date
2020/05/04
Registered Date
2020/05/06
Last Updated Date
2023/12/10
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004986 |
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Unique Protocol ID | H-1905-012-078 |
Public/Brief Title | Comparison between low-dose and high-dose rocuronium use in general anesthesia for Cesarean section |
Scientific Title | Comparison between low-dose and high-dose rocuronium use in general anesthesia for Cesarean section |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
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 | H-1905-012-078 |
Approval Date | 2019-05-20 |
Institutional Review Board Name | Pusan national university hospital Institutional Review Board |
Institutional Review Board Address | 179, Gudeok-ro, Seo-gu, Busan |
Institutional Review Board Telephone | 051-240-7529 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Boo young Hwang |
Title | associate pf. |
Telephone | +82-51-240-7399 |
Affiliation | Pusan National University Hospital |
Address | Gudeok ro 179, Seo gu, Pusan, Republic of Korea |
Contact Person for Public Queries | |
Name | Boo young Hwang |
Title | associate pf. |
Telephone | +82-51-240-7399 |
Affiliation | Pusan National University Hospital |
Address | Gudeok ro 179, Seo gu, Pusan, Republic of Korea |
Contact Person for Updating Information | |
Name | Boo young Hwang |
Title | associate pf. |
Telephone | +82-51-240-7399 |
Affiliation | Pusan National University Hospital |
Address | Gudeok ro 179, Seo gu, Pusan, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-08-01 Actual | |
Target Number of Participant | 20 | |
Primary Completion Date | 2023-10-31 , Actual | |
Study Completion Date | 2023-11-30 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Pusan National University Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-08-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Pusan National University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Pusan National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | During cesarean section, rapid anesthesia induction is required by administering a high concentration of muscle relaxant to reduce the difficulty of tracheal intubation and complications caused by various general anesthetic agents. In general anesthesia, muscle relaxants are also essential for ease of surgery and reduction of body tissue damage and cardiovascular responses. However, muscle relaxants often delay breath recovery after surgery, resulting in the use of ventilators. It can also be transmitted to the fetus through the placenta. In fact, this experiment was devised to find out whether it is appropriate for a mother and a fetus to use a high concentration of muscle relaxant by measuring the concentration of muscle relaxant passing through the placenta. Only those applicants who have made a cesarean section due to general anesthesia by posting a recruitment notice will conduct the experiment. It is divided into a low-concentration group (0.6mg/kg) and a high-concentration group(1.0mg/kg), followed by anesthesia and muscle relaxant administration, intubation time, ease of intubation, skin incision time, umbilical cord clamping time, T1 appearing time, T2 appearing time, extubation The time, TOF0.9 time, eye open time, recovery room exit time, total rocuronium amount entered, total remifentanil amount, Apgar score, complication, etc. are recorded. After dropping 60 μl of the patient's blood onto the electrode on a screen-printed slide, and measuring the chronoamperometry after 3 minutes, obtain a current signal according to the concentration of rocuronium present in the blood and calculate the concentration of rocuronium through calculation. Layer. Rocuronium concentrations are detected in maternal venous blood just before ligation of umbilical cord blood, umbilical vein blood, and venous blood of pregnant mother just before leaving the recovery room. The aim is to observe the concentration of rocuronium that has actually passed umbilical cord blood, and compare side effects between both groups. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-control |
Time Perspective | Prospective |
Target Number of Participant | 20 |
Cohort/Group Number | 2 |
Cohort/ Group 1 |
Cohort/Group Label Low dose |
Cohort/Group Description In a low-concentration group, we administer 0.6mg/kg rocuronium. After the induction, we check intubation time, ease of intubation, skin incision time, umbilical cord clamping time, T1 appearing time, T2 appearing time, extubation The time, TOF0.9 time, eye open time, recovery room exit time, total rocuronium amount entered, total remifentanil amount, Apgar score, complication, etc. are recorded. After dropping 60 μl of the patient's blood onto the electrode on a screen-printed slide, and measuring the chronoamperometry after 3 minutes, obtain a current signal according to the concentration of rocuronium present in the blood and calculate the concentration of rocuronium through calculation. Rocuronium concentrations are detected in maternal venous blood just before ligation of umbilical cord blood, umbilical vein blood, and venous blood of pregnant mother just before leaving the recovery room. |
|
Cohort/ Group 2 |
Cohort/Group Label High dose |
Cohort/Group Description In a high-concentration group, we administer 1.0mg/kg rocuronium. After the induction, we check intubation time, ease of intubation, skin incision time, umbilical cord clamping time, T1 appearing time, T2 appearing time, extubation The time, TOF0.9 time, eye open time, recovery room exit time, total rocuronium amount entered, total remifentanil amount, Apgar score, complication, etc. are recorded. After dropping 60 μl of the patient's blood onto the electrode on a screen-printed slide, and measuring the chronoamperometry after 3 minutes, obtain a current signal according to the concentration of rocuronium present in the blood and calculate the concentration of rocuronium through calculation. Rocuronium concentrations are detected in maternal venous blood just before ligation of umbilical cord blood, umbilical vein blood, and venous blood of pregnant mother just before leaving the recovery room. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Adult patients over 18 years of age who have undergone a cesarean section,I and II American Society of Anesthesiology. |
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Sampling Method | If the patient agrees to the experiment, the patient is assigned a random number from 1 to 20 numbers, and the odd number belongs to the high concentration and the even number falls to the low concentration group. The number of researchers per group is ten. |
Condition(s)/Problem(s) |
* (O00-O99)Pregnancy, childbirth and the puerperium (O82.9)Delivery by caesarean section, unspecified Pregnant women |
Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 18Year~45Year |
|
Description Adult patients over 18 years of age who have undergone a cesarean section, ASA I and II |
|
Exclusion Criteria |
If the patient disagrees, a neuropsychiatric disorder, a history of medication or muscle relaxant administration that may affect pre-operative muscle relaxants, kidney failure, or liver failure |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Rocuronium concentration of umbilical vein after umbilical cord clamping |
|
Timepoint | at the time of decision to leave the recovery room |
|
Secondary Outcome(s) 1 | ||
Outcome | Time from the time the muscle relaxant was given until the tracheal intubation |
|
Timepoint | at the tracheal intubation |
|
Secondary Outcome(s) 2 | ||
Outcome | Skin incision time from the time the muscle relaxant was given |
|
Timepoint | at the skin incision |
|
Secondary Outcome(s) 3 | ||
Outcome | Time for umbilical cord clamping from the time the muscle relaxant was given |
|
Timepoint | at the umbilical cord clamping |
|
Secondary Outcome(s) 4 | ||
Outcome | Side effects in mother and fetus |
|
Timepoint | at the time to leave the recovery room |
|
Secondary Outcome(s) 5 | ||
Outcome | Rocuronium concentration of maternal vein after umbilical cord clamping and PACU discharge |
|
Timepoint | after umbilical cord clamping and at chiacharge from PACU |
11. Study Results and Publication
Result Registered |
Yes
Results Upload |
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Final Enrollment Number | 18 |
Number of Publication | 0 |
Results Upload | tableresult.docx |
Date of Posting Results | 2023/12/10 |
Protocol URL or File Upload | protocol.xlsx |
Brief Summary | No demographic differences were observed between the two groups. Additionally, no significant differences were found in intubation ease, time from rocuronium administration to skin incision, cord clamping, TOF ratio > 0.9, eye opening, extubation, PACU stay time, 1 min and 5 min Apgar score and venous blood gas analysis of the blood from the umbilical vein between both groups. However, the time from rocuronium administration to T3 disappearance was shorter in H group than in C group (p=0.009). The time from rocuronium administration to T1 and T2 reappearance were longer in H group than in C group (p=0.003, 0.009). The administered remifentanil dose was higher in H group (p=0.042), and the rocuronium concentrations in both maternal vein immediately before cord clamping and after the Aldrete score reached 9 and umbilical vein immediately after cord clamping were higher in H group than in C group (p=0.004, 0.002, and <0.001). |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2021. 12 |
Way of Sharing | To be made available at a later date
(byhwang@pusan.ac.kr) |
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