UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035832 |
|---|---|
| Receipt number | R000040284 |
| Scientific Title | The prospective observational study about respiratory depression after caesarean section with spinal morphine. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2024/08/13 12:19:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The prospective observational study about respiratory depression after caesarean section with spinal morphine.
Acronym
Respiratory depression after caesarean section
Scientific Title
The prospective observational study about respiratory depression after caesarean section with spinal morphine.
Scientific Title:Acronym
Respiratory depression after caesarean section
Region
| Japan |
Condition
Condition
patients undergoing caesarean section under the spinal anesthesia technique
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess the rate of cumulative bradyapnea time (total bradyapnea time/total monitoring time) and its related factors
to evaluate the time to first bradyapnea event,the incidence of bradyapnea and its related factors, the incidence of hypoxemia and its related factors, and the occurrence of clinically relevant episodes of respiratory depression.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to assess the rate of cumulative bradyapnea time (total bradyapnea time/total monitoring time) and its related factors
Key secondary outcomes
to evaluate 1) the time to first bradyapnea event, 2) the incidence of bradyapnea and its related factors, 3) the incidence of hypoxemia and its related factors, and 4) the occurrence of clinically relevant episodes of respiratory depression.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women aged more than or equal to20-years-old who were undergoing cesarean delivery performed between 0700 to 2000 hours under spinal anesthesia from April 2019 to March 2020
Key exclusion criteria
patients with psychiatric disease and neuromuscular disease
patients who did not provide written informed consent
patients who received other than single-shot spinal anesthesia (multiple administrations of spinal anesthesia, epidural anesthesia, combined spinal-epidural anesthesia and general anesthesia)
patients who underwent cesarean delivery following epidural labor
patients who required additional sedatives and analgesics intraoperatively
Women who received oxygen administration postoperatively, cases which had missing data about patients demographics and respiratory monitoring, and cases which performed respiratory monitoring within 6 hours were excluded from data analysis.
Target sample size
153
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ida |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8521
Address
Shijo-machi
TEL
0744-22-3051
nwnh0131@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ida |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8521
Address
Shijo-machi
TEL
0744-22-3051
Homepage URL
nwnh0131@yahoo.co.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 Shijo
Tel
09079627114
nwnh0131@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
not available
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36626021/
Number of participants that the trial has enrolled
159
Results
Results: Of 159 patients, the Berlin Questionnaire was positive in 16.3%, and 77 (48.4%) experienced sustained bradypnea. The median rate of cumulative sustained bradypnea time was 0.70% (interquartile range 0.35-1.45%) without any related factors. The incidence of immediate bradypnea and sustained and immediate hypoxemia were 58.5%, 24.5%, and 37.7%, respectively. However, none of the factors were significant.
Results date posted
| 2024 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The primary outcome of interest was the median rate of cumA total of 253 women were screened; of them, 219 were included in this study. However, patients who received oxygen postoperatively (n = 14), patients with missing Berlin Questionnaire data (n = 16), and patients who lacked data regarding postoperative respiratory monitoring (n = 20) (Fig. 1) were excluded. Finally, 159 patients were included in the analysis. The patient demographics are presented in Table 1. The mean body mass index was 26.0 kg/m2, and it was 30 kg/m2 in 20 women. Of the 159 patients, 17 (10.6%) had hypertensive disorder of pregnancy and 26 (16.3%) had a positive result on the Berlin Questionnaire. The distribution of total monitoring hours was shown inlative sustained bradypnea time (total sustained bradypnea time/total monitoring time) and its related factors. The secondary outcomes included the following: (1) median time to first sustained bradypnea after intrathecal morphine administration; (2) incidence of sustained and immediate bradypnea and its related factors; (3) incidence of sustained and immediate hypoxemia and related factors; and (4) occurrence of a clinically relevant episode ofer6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Participant flow
A total of 253 women were screened; of them, 219 were included in this study. However, patients who received oxygen postoperatively (n = 14), patients with missing Berlin Questionnaire data (n = 16), and patients who lacked data regarding postoperative respiratory monitoring (n = 20) (Fig. 1) were excluded. Finally, 159 patients were included in the analysis. The patient demographics are presented in Table 1. The mean body mass index was 26.0 kg/m2, and it was 30 kg/m2 in 20 women. Of the 159 patients, 17 (10.6%) had hypertensive disorder of pregnancy and 26 (16.3%) had a positive result on the Berlin Questionnaire.
Adverse events
None
Outcome measures
The primary outcome of interest was the median rate of cumulative sustained bradypnea time (total sustained bradypnea time/total monitoring time) and its related factors. The secondary outcomes included the following: (1) median time to first sustained bradypnea after intrathecal morphine administration; (2) incidence of sustained and immediate bradypnea and its related factors; (3) incidence of sustained and immediate hypoxemia and related factors; and (4) occurrence of a clinically relevant episode of respiratory depression, which was defined as that which required naloxone or calling the rapid response team. The following definitions were used in this study with reference to a previous study [13]: sustained bradypnea = respiratory rate < 8 breaths/min lasting at least 25 s; immediate bradypnea = respiratory rate < 8 breaths/min lasting at least 15 s; sustained hypoxemia = SpO2 < 92% lasting at least 25 s; and immediate hypoxemia = SpO2 < 92% lasting at least 15 s.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040284
