Completed

NCT Number: NCT03953872

Antihypertensives in Non-cardiac Surgical Population

A cohort of hypertension patients undergoing elective non-cardiac surgery was constructed to investigate current status of antihypertensive drug treatment in non-cardiac surgical population.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Perioperative Antihypertensive

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

Perioperative changes in blood pressure (BP) are associated with perioperative risks. However, there is little information regarding the current status of antihypertensive treatment in non-cardiac surgical population. A cohort of 351 hypertension patients aged between 18 to 85-year old undergoing elective non-cardiac surgery was constructed to investigate the application of antihypertensive drugs, systemic involvement, perioperative hemodynamics and internal environment to grasp the perioperative impact of different antihypertensive drugs, and to further provide a reference for the preoperative antihypertensive strategy of surgery patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients undergoing elective non-cardiac surgery with hypertension(i.e., with a systolic blood pressure(SBP) of >=140 mmHg and/or a diastolic blood pressure(DBP) of >=90 mmHg based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) or self-reported use of antihypertensive medication

Exclusion criteria

Patients under the age of 18 years old
Patients more than 85 years old
Patients suspected of intracranial hypertension

Treatment and study plan

Primary outcomes

perioperative blood press(BP)

Time frame: from the moment on arrival to the operating room until the moment leaving PACU, assessed up to 240 minutes.

baseline BP before the operation, when entering and exiting post-anesthesia care unit(PACU)

Secondary outcomes

pH, base excess, and concentration of HCO3- in blood gases

Time frame: 5 minutes after extubating in PACU

arterial blood gases detected by using the ABL800 (Radiometer Med Aps Ltd, Copenhagen, Denmark)
the incidence of hypotension in PACU

Time frame: from the moment on arrival to PACU until 60 minutes after arriving or the moment leaving PACU, whichever came first, assessed up to 240 minutes.

If there were more than two consecutive episodes of hypotension (which was defined as SBP less than 80% of baseline) a "rescue" intravenous bolus of 100 mg of phenylephrine was given.
the incidence of hypertension in PACU

Time frame: from the moment on arrival to PACU until 60 minutes after arriving or the moment leaving PACU, whichever came first, assessed up to 240 minutes.

the incidence of hypertension, which was defined as SBP greater than 120% of baseline
hospitalization days

Time frame: from the date of admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days

The duration of this single episode of hospitalization

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Current Status of Antihypertensive Drug Treatment in Non-cardiac Surgical Population

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: May 17, 2019
Registry last updated: May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.