Status Approved
First Submitted Date
2020/04/14
Registered Date
2020/05/21
Last Updated Date
2023/02/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005046 |
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Unique Protocol ID | 2020-0533 |
Public/Brief Title | Effect of norepinephrine for the prevention of hypotension after spinal anesthesia in the elderly |
Scientific Title | Effect of norepinephrine continuous infusion for the prevention of hypotension after spinal anesthesia with propofol sedation in the elderly |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Submitted approval |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2020-0533 |
Approval Date | 2020-04-13 |
Institutional Review Board Name | Asan Medical Center Institutional Review Board |
Institutional Review Board Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea |
Institutional Review Board Telephone | 02-3010-7165 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hyungtae Kim |
Title | associate professor |
Telephone | +82-2-3010-3883 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43gil, Songpa-gu, Seoul |
Contact Person for Public Queries | |
Name | Ha-Jung Kim |
Title | assistant professor |
Telephone | +82-2-3010-0338 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43gil, Songpa-gu, Seoul |
Contact Person for Updating Information | |
Name | Ha-Jung Kim |
Title | assistant professor |
Telephone | +82-2-3010-0338 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43gil, Songpa-gu, Seoul |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2020-08-16 Actual | |
Target Number of Participant | 70 | |
Primary Completion Date | 2021-07-01 , Actual | |
Study Completion Date | 2021-07-01 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Asan Medical Center | |
Recruitment Status | Completed | |
Date of First Enrollment | 2020-08-16 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | A recent paper article reported that regional anesthesia has an advantage in clinical outcomes compared to general anesthesia in older patients undergoing hip surgery. However, spinal ansthesia-induced hypotension often occurs in the elderly. Especially, if propofol is administered intravenously for sedation during surgery, the incidence of hypotension could be higher. Perioperative hypotension is associated with imbalance in oxygen demand and supply, causing postoperative cardiac infarction or acute kidney damage. Since elderly patients, in particular, often have multiple comorbidities, these postoperative complications might induce fatal consequences, prevention of perioperative hypotension is critical to improve the patient's prognosis. In the past, phenylephrine has been commonly used in the management of spinal anesthesia-induced hypotension. However, there have been arguments that using norepinephrine is more effective and safer than using phenylephrine in patients undergoing C-section under spinal anesthesia. Because phenylephrine, the peripheral vasoconstrictor, could cause the bradycardia and reduce cardiac output, it is thought that the use of norepinephrine in the management of hypotension could be an alternative in the elderly whose cardiovascular function is relatively weak. Therefore, we aimed to evaluate whether norepinephrine could effectively prevent hypotension in older patients scheduled to undergo hip surgery under spinal anesthesia with sedation using propofol. -This study includes 70 patients who signed consent forms among those undergoing hip surgery under spinal anesthesia with sedation using propofol at a tertiary center (Asan Medical Center). The participants are randomly decided into two groups; control group vs norepinephrine group (35 participants in each group). - Standard monitoring should be done when the participant arrives in the operating room. Oxygen is supplied using a facial mask to all patients and spinal anesthesia with 10mg of heavy marcaine and 15mcg of fentanyl is performed. At this point, the continuous infusion of drugs(normal saline or norepinephrine) begins according to the assigned group. After 5 minutes, assessment of anesthetic level is performed. Then, start the target controlled infusion of the propofol. Pleth variability index is monitored to evaluate the volume status of participants and normovolema is maintained based on pleth variability index during the surgery. Infusion of propofol and study drug is stopped when the surgery is finished. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Prevention |
Phase | Phase4 |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | Group C: normal saline-0.15cc/kg/hr, intravenously continuous infusion, from the time point that the participants take the supine position after the intrathecal injection of local anesthetics to the end of surgery Group N: norepinephrine-0.15cc/kg/hr (0.05mcg/kg/min), intravenously continuous infusion, from the time point that the participants take the supine position after the intrathecal injection of local anesthetics to the end of surgery There is no difference in anesthetic management in each group except the drug intravenously administered; normal saline vs norepinephrine. |
Number of Arms | 2 |
Arm 1 |
Arm Label Group C |
Target Number of Participant 35 |
|
Arm Type Placebo comparator |
|
Arm Description Group C: normal saline-0.15cc/kg/hr, intravenously continuous infusion, from the time point that the participants take the supine position after the intrathecal injection of local anesthetics to the end of surgery |
|
Arm 2 |
Arm Label Group N |
Target Number of Participant 35 |
|
Arm Type Experimental |
|
Arm Description Group N: norepinephrine-0.15cc/kg/hr (0.05mcg/kg/min), intravenously continuous infusion, from the time point that the participants take the supine position after the intrathecal injection of local anesthetics to the end of surgery |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M16.9)Coxarthrosis, unspecified Patients who are scheduled to undergo a hip surgery |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 70Year~No Limit |
|
Description * American Society of Anesthesiologists Physical Status 1-3 * age: equal to or older than 70 years * patients scheduled to undergo a hip surgery under spinal anesthesia with propofol sedation |
|
Exclusion Criteria |
* patients who don't agree to participate in this study * patients with uncontrolled hypertension, hyperthyroidism, dementia, symptomatic coronary artery disease, or hemoglobin <10g/dL * patients with allergy to propofol, fentanyl, or bupivacaine * patients who are cont coagulopathy, severe aortic stenosis/mitral stenosis, active infection on lumbar region * patients who are judged to be inappropriate for this study by authors |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | number of hypotensive episodes |
|
Timepoint | intraoperative period |
|
Secondary Outcome(s) 1 | ||
Outcome | number of hypertensive episodes |
|
Timepoint | intraoperative period |
|
Secondary Outcome(s) 2 | ||
Outcome | total amount of phenylephrine administered |
|
Timepoint | intraoperative period |
|
Secondary Outcome(s) 3 | ||
Outcome | total amount of administered fluid |
|
Timepoint | intraoperative |
|
Secondary Outcome(s) 4 | ||
Outcome | number of hypotensive episodes |
|
Timepoint | during recovery period at post-anesthetic care unit |
|
Secondary Outcome(s) 5 | ||
Outcome | complications |
|
Timepoint | postoperative period |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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