UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044737 |
|---|---|
| Receipt number | R000050993 |
| Scientific Title | Effects of intravenous administration of magnesium sulfate in propofol-based sedation for ERCP in elderly patients: a randomized, double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2021/07/02 |
| Last modified on | 2023/03/25 16:06:36 |
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Basic information
Public title
Effects of intravenous administration of magnesium sulfate in propofol-based sedation for ERCP in elderly patients: a randomized, double-blind, placebo-controlled study
Acronym
intravenous magnesium sulfate for ERCP sedation
Scientific Title
Effects of intravenous administration of magnesium sulfate in propofol-based sedation for ERCP in elderly patients: a randomized, double-blind, placebo-controlled study
Scientific Title:Acronym
intravenous magnesium sulfate for ERCP sedation
Region
| Asia(except Japan) |
Condition
Condition
Inpatients aged 65 to 79 years who were scheduled for ERCP were recruited into the study.
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that i.v. magnesium sulfate reduces propofol requirements during ERCP procedures and improves post-ERCP recovery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes was propofol requirements.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In group M, 40 mg/kg magnesium sulfate diluted with normal saline to a total volume of 100 ml was administered for 15 minutes prior to the beginning of the procedure. An initial bolus dose of 1 mg/kg propofol was administered over 30 seconds followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h. The Ramsay Sedation Scale was used to assess the level of sedation throughout the procedure, and a score of 5 or higher was targeted for the procedure. In case of a score lower than 5 or patient expressed discomfort and difficulty in maneuvering the endoscope, propofol 0.25mg/kg was used in the form of a bolus as rescue drugs. Meanwhile, the propofol infusion rate was upregulated by 0.5mg/kg/h, and repeated the process if necessary.
Interventions/Control_2
Patients in the control group received an equal volume of saline solution, which could not be visually identified from magnesium sulfate by the blind anesthesiologist. All patients received standard sedation with propofol.
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
| 65 | years-old | < |
Age-upper limit
| 79 | years-old | > |
Gender
Male and Female
Key inclusion criteria
After obtaining written informed consent, adult patients of American Society of Anesthesiologists (ASA) physical status I through III aged between 65 and 79 years of either sex scheduled for ERCP under sedation were included in this study.
Key exclusion criteria
1, a history of adverse events with prior sedation;
2, known hypersensitivity to any of the drugs that would be used in the study;
3, patients with ASA Class 4 or 5;
4, pre-existing hypoxemia (SpO2 < 90%);
5, hypotension (systolic blood pressure < 90mmHg) or uncontrolled hypertension (systolic blood pressure > 170mmHg, diastolic blood pressure > 100mmHg);
6, severe cardiac, renal, neurological, or liver diseases;
7, patients who had taken any sedative drug within the previous 24 hours and those who refused participation;
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | jie |
| Middle name | |
| Last name | Chen |
Organization
People's Hospital of Chongqing Banan District
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66234145
cjandsh@tmmu.edu.cn
Public contact
Name of contact person
| 1st name | jie |
| Middle name | |
| Last name | Chen |
Organization
People's Hospital of Chongqing Banan District
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66234145
Homepage URL
cjandsh@tmmu.edu.cn
Sponsor or person
Institute
Department of Anaesthesiology, People's Hospital of Chongqing Banan District
Institute
Department
Personal name
Funding Source
Organization
Department of Anaesthesiology, People's Hospital of Chongqing Banan District
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the People's Hospital of Chongqing Banan District
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing 401320, P.R China
Tel
+81-086-23-66291798
409560509@qq.com
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
| 2021 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050993
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050993
Number of participants that the trial has enrolled
80
Results
The total propofol consumption were reduced by 21.4 percent in the group M compared with the group N. The incidences of respiratory depression episodes and involuntary movement were less in the group M than those in the group N . In the group M, the patients experienced less pain than those in the group N at 30min after the procedure. Correspondingly, the patients satisfaction was clearly higher in the group M.
Results date posted
| 2022 | Year | 09 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no significant differences in the demographic characteristics and ERCP procedure details between the two groups.
Participant flow
A total of eighty-four patients were enrolled initially in the present study. Of these, four patients were excluded due to severe renal failure (n = 1) and refusal to sign informed consent (n = 3). Ultimately, a total of 80 elderly patients (35 males) were evaluated.
Adverse events
There were no significant differences in PONV, lethargy, and arrhythmias between the two groups.
Outcome measures
A single bolus of 40 mg/kg of intravenous magnesium can significantly reduce propofol consumption during ERCP, with higher sedation success and lower adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050993
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