The Relationship Between Upper and Lower Extremity Blood Pressure in Thyroid Surgery Patients Under General Anesthesia

NCT ID: NCT06590064

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2026-01-31

Brief Summary

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The goal of this observational study is to clarify the relationship between upper and lower limb blood pressure in thyroid surgery patients under general anesthesia. The hemodynamic state during anesthesia is different from that during the awake state. Therefore, to assess whether the difference in blood pressure between the upper and lower limbs observed in the awake state is consistent with that observed under general anesthesia, the investigators will compare the inter-limb blood pressure differences before anesthesia induction and during general anesthesia.

Detailed Description

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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.

Conditions

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Blood Pressure Diseases of the Thyroid Gland

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group T

Thyroid surgery patients under general anesthesia

Non-invasive Blood Pressure Measurement

Intervention Type DEVICE

Non-invasive Blood Pressure Measurement in Both Upper and Lower Limbs

Interventions

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Non-invasive Blood Pressure Measurement

Non-invasive Blood Pressure Measurement in Both Upper and Lower Limbs

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Ilsan Cha hospital

OTHER

Sponsor Role lead

Responsible Party

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Jee Young Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JOOHYUN LEE

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Pain medicine, Ilsan Cha hospital

Locations

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Ilsan Cha hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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YOON JI CHOI

Role: CONTACT

(+82)1020204844

HYE AN YEO

Role: CONTACT

(+82)01098004693

Facility Contacts

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YOON JI CHOI

Role: primary

(+82)1020204844

HYE AN YEO

Role: backup

(+82)1098004693

YOON JI CHOI

Role: backup

HYE AN YEO

Role: backup

JOO HYUN LEE

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 30817444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34916049 (View on PubMed)

Other Identifiers

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ICICC-OS-24-02

Identifier Type: -

Identifier Source: org_study_id

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