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

Recruiting

• Conditions: Blood Pressure; Diseases of the Thyroid Gland
• Interventions: Device: Non-invasive Blood Pressure Measurement

• Registration Number: NCT06590064
• Lead Sponsor: Ilsan Cha hospital

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.

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 Timeline

• Study Start: 2024-07-15
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group T	Non-invasive Blood Pressure Measurement	Thyroid surgery patients under general anesthesia

Primary Outcome Measures

Name	Time	Method
d_MBP(awake)	Simultaneously measured values in operating room before anesthesia induction	Difference between upper and lower extremities mean blood pressure in awake state
d_MBP(GA)	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

Secondary Outcome Measures

Name	Time	Method
d_SBP(awake)	Simultaneously measured values in operating room before anesthesia induction	Difference between upper and lower extremities systolic blood pressure in awake state
d_SBP(GA)	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
d_DBP(awake)	Simultaneously measured values in operating room before anesthesia induction	Difference between upper and lower extremities diastolic blood pressure in awake state
d_DBP(GA)	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

Trial Locations

Locations (1)

Ilsan Cha hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of