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

NCT06590064 | Completed DMC

• 1 other identifier: ICICC-OS-24-02
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diseases of the Thyroid Gland; Blood Pressure

Keywords

General anesthesia; Thyroid surgery; Lower extremity blood pressure

Outcome Measures

Primary Outcomes (2)

• d_MBP(awake)

  Difference between upper and lower extremities mean blood pressure in awake state

  Simultaneously measured values in operating room before anesthesia induction

• d_MBP(GA)

  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 Outcomes (4)

• d_SBP(awake)

  Simultaneously measured values in operating room before anesthesia induction

• d_SBP(GA)

  Simultaneously measured values during general anesthesia in a stable state without significant stimulation

• d_DBP(awake)

  Simultaneously measured values in operating room before anesthesia induction

• d_DBP(GA)

  Simultaneously measured values during general anesthesia in a stable state without significant stimulation

Study Arms (1)

Group T

Thyroid surgery patients under general anesthesia

Device: Non-invasive Blood Pressure Measurement

Interventions

Non-invasive Blood Pressure Measurement DEVICE

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

Group T

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving elective thyroid surgery under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ilsan Cha hospital: lead
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Ilsan Cha hospital

Goyang-si, Gyeonggi-do, 10449, South Korea

Location

Related Publications (2)

• 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.

  PMID: 34916049 BACKGROUND

• 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.

  PMID: 30817444 RESULT

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• JOOHYUN LEE

  Department of Anesthesia and Pain medicine, Ilsan Cha hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: July 15, 2024
• Primary Completion: March 25, 2025
• Study Completion: December 31, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

KR (1)