Antihypertensives in Non-cardiac Surgical Population

Completed

• Conditions: Perioperative Antihypertensive

• Registration Number: NCT03953872
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-11-23
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Study First Submitted: 2019-04-27
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-16
• Last Update Submitted: 2019-05-16
• Study First Posted: 2019-05-17
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
perioperative blood press(BP)	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 Outcome Measures

Name	Time	Method
pH, base excess, and concentration of HCO3- in blood gases	5 minutes after extubating in PACU	arterial blood gases detected by using the ABL800 (Radiometer Med Aps Ltd, Copenhagen, Denmark)
the incidence of hypertension in PACU	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
the incidence of hypotension in PACU	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.
hospitalization days	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

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China