- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06590064
The Relationship Between Upper and Lower Extremity Blood Pressure in Thyroid Surgery Patients Under General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Non-invasive blood pressure measurement during surgery is typically conducted on the upper arm, and previous studies about the relationship between intraoperative blood pressure fluctuation and postoperative mortality and morbility have also based on the upper arm measurements. However, in clinical practice, if monitoring blood pressure in the upper arm is not feasible during surgery, the cuff usually be placed on the ankle.
According to a previous study, the systolic blood pressure at the ankle is approximately 17.0 mmHg higher than the systolic blood pressure at the arm in the supine position (95% CI 15.4-21.3 mmHg), while the diastolic blood pressure did not show significant differences in awake state. Since the hemodynamic state of patients under anesthesia differs from that of awake patients, there is insufficient evidence to directly apply the known differences between upper and lower limb blood pressures in awake patients to set target blood pressure ranges during anesthesia. As a result, anesthesiologists often rely on clinical judgment in these situations.
Therefore, this study sets the null hypothesis that 'the differences in blood pressure between the upper and lower limbs before and after anesthesia are the same.' The goal is to determine whether the previously known relationship between upper and lower limb blood pressures in awake patients can be applied to patients under general anesthesia. Additionally, this study aims to investigate the relationship between upper and lower limb blood pressures when the lower limb blood pressure is outside the normal range during general anesthesia.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
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Goyang-si, Gyeonggi-do, South Korea, 10449
- Ilsan Cha Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients having elective thyroid surgery under general anesthesia
- Aged between 20 to 80 years old
- American Society of Anesthesiologist(ASA) Physical Status Class I or II
- Individuals who have voluntarily given written consent to participate in this clinical study
Exclusion Criteria:
- Patients with Diabetes Mellitus or Peripheral vascular disease
- Patients with a history of Heart disease; Myocardial infarction, Heart failure, etc.
- Patients with Arrhythmia
- Patients with musculoskeletal abnormalities
- Patients for whom the placement of a non-invasive blood pressure cuff is contraindicated: inflammatory diseases or wounds causing pain at the cuff site, severe edema, thrombophlebitis, etc.
- Other cases deemed unsuitable for the study by the researcher: absence of appropriately sized blood pressure cuffs, placement of a pressurized blood pressure cuff expected to affect the induction and maintenance of general anesthesia, history of mental illness, etc.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group T
Thyroid surgery patients under general anesthesia
|
Non-invasive Blood Pressure Measurement in Both Upper and Lower Limbs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
d_MBP(awake)
Time Frame: Simultaneously measured values in operating room before anesthesia induction
|
Difference between upper and lower extremities mean blood pressure in awake state
|
Simultaneously measured values in operating room before anesthesia induction
|
|
d_MBP(GA)
Time Frame: Simultaneously measured values during general anesthesia in a stable state without significant stimulation
|
Difference between upper and lower extremities mean blood pressure during general anesthesia
|
Simultaneously measured values during general anesthesia in a stable state without significant stimulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
d_SBP(awake)
Time Frame: Simultaneously measured values in operating room before anesthesia induction
|
Difference between upper and lower extremities systolic blood pressure in awake state
|
Simultaneously measured values in operating room before anesthesia induction
|
|
d_SBP(GA)
Time Frame: Simultaneously measured values during general anesthesia in a stable state without significant stimulation
|
Difference between upper and lower extremities systolic blood pressure during general anesthesia
|
Simultaneously measured values during general anesthesia in a stable state without significant stimulation
|
|
d_DBP(awake)
Time Frame: Simultaneously measured values in operating room before anesthesia induction
|
Difference between upper and lower extremities diastolic blood pressure in awake state
|
Simultaneously measured values in operating room before anesthesia induction
|
|
d_DBP(GA)
Time Frame: Simultaneously measured values during general anesthesia in a stable state without significant stimulation
|
Difference between upper and lower extremities diastolic blood pressure during general anesthesia
|
Simultaneously measured values during general anesthesia in a stable state without significant stimulation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: JOOHYUN LEE, Department of Anesthesia and Pain medicine, Ilsan Cha hospital
Publications and helpful links
General Publications
- Jessen MK, Vallentin MF, Holmberg MJ, Bolther M, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Lind PC, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Hoybye M, Henriksen J, Karlsson CM, Balleby IR, Rasmussen MS, Paelestik K, Granfeldt A, Andersen LW. Goal-directed haemodynamic therapy during general anaesthesia for noncardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2022 Mar;128(3):416-433. doi: 10.1016/j.bja.2021.10.046. Epub 2021 Dec 13.
- Sheppard JP, Albasri A, Franssen M, Fletcher B, Pealing L, Roberts N, Obeid A, Pucci M, McManus RJ, Martin U; British and Irish Hypertension Society. Defining the relationship between arm and leg blood pressure readings: a systematic review and meta-analysis. J Hypertens. 2019 Apr;37(4):660-670. doi: 10.1097/HJH.0000000000001958.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICICC-OS-24-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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