ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12616001370493

Ethics application status

Approved

Date submitted

27/09/2016

Date registered

4/10/2016

Date last updated

23/09/2022

Date data sharing statement initially provided

16/10/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Impact of continuing or withholding blood pressure reducing drugs on the blood pressure stability and quality of recovery following day surgery procedures

Scientific title

Preoperative Renin-Angiotensin system antagonists and blood pressure responses during ambulatory procedures

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1188-0410

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Haemodynamic instability

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Group II: Patients who are on Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker (ARB) (either as monotherapy or in combination with other antihypertensive agents) AND took a dose of ACEI/ARB within 10 hours prior to surgery. This group is presumed to be under the influence of ACEI/ARB at the time of anaesthesia.

Medical and treatment details including antihypertensive therapy, of the participants will be collected from patient records. Details of anaesthetic management, intraoperative haemodynamic changes and postoperative recovery details will be collected at the end of surgery. With a telephone followup, the quality of recovery will be ascertained 24 hours following surgery.

Intervention code [1]

Not applicable

Comparator / control treatment

Group 1: Patients who are not on any antihypertensive agents, who are on anti hypertensive therapy other than ACEIs or ARBs and patients on ACEIs or ARBs who ceased taking these drugs atleast 10 hours prior to surgery. This group is presumed to be devoid of ACEI/ARB effect at the time of anaesthesia.

Control group

Active

Outcomes

Primary outcome [1]

Significant hypotension (yes/no) .

Hypotension will be defined in the following ways.
1. Based on systolic blood pressure: Drop of more than 30% systolic compared to baseline for minimum 5 minutes duration (that is, if these features are present over 2 consecutive readings).
2. Based on the change in mean arterial pressure: Decrease in mean arterial blood pressure <55 mm Hg regardless of the duration

Timepoint [1]

1) a) first 15 minutes of anaesthetic induction 1b) over the duration of surgery 1c) over the duration of stay in recovery room

Primary outcome [2]

Change in mean perioperative systolic blood pressure from mean pre-operative (baseline) measures (as a continuous variable) assessed using non-invasive blood pressure monitor

Timepoint [2]

over the duration of surgery

Primary outcome [3]

Preoperative hypertension assessed using non invasive blood pressure monitor. Hypertension will be classified as follows.
1. Stage I hypertension/inadequate control of blood pressure: Blood pressure of systolic greater than or equal to 140 mm Hg and/or diastolic greater than or equal to 90 mm Hg
2. Stage II hypertension: Blood pressure of systolicgreater than or equal to 160 mm Hg and/or diastolic greater than or equal to 100 mm Hg
3. Stage III (severe) hypertension: Blood pressure greater than or equal to 180 mm Hg and/or diastolic greater than or equal to 110 Hg
4. Stage IV hypertension: Systolic greater than or equal to 210 mm Hg or diastolic greater than or equal to 120 mm Hg.

Timepoint [3]

on admission blood pressure

Secondary outcome [1]

Length of stay in recovery room defined as the time difference between arrival to discharge from recovery room. This is collected by review of medical records

Timepoint [1]

Time of discharge

Secondary outcome [2]

Composite of occurrence of unplanned readmission or any major surgical or medical complications, assessed through review of medical records

Timepoint [2]

24 hours post surgery

Secondary outcome [3]

Primary outcome: Variability of systolic blood pressure assessed using non invasive blood pressure monitor

Timepoint [3]

Over the duration of surgery

Secondary outcome [4]

quality of recovery assessed using a 15 item validated postoperative recovery questionnaire called QoR-15.

Timepoint [4]

baseline: on admission and
postoperative: 24 hours following surgery

Eligibility

Key inclusion criteria

All patients undergoing day-case procedures under general anaesthesia at TPCH during the study period.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patient refusing to participate, communication difficulty due to language barrier, emergency surgery.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Binary outcomes will be analysed using Pearson’s Chi square tests or Fisher’s exact tests as indicated. Univariable and multivariable logistic regression analysis will be used to test associations between exposures of interest (e.g. Antihypertensive group) and binary outcomes (e.g. significant hypotension). Models will be adjusted for measured confounders such as age, BMI and comorbidities.
The differences between mean changes in blood pressure will be assessing using mean-comparison tests (t-tests or ANOVA). Further analyses will include univariable and multivariable linear regression analyses as indicated to test associations between exposures of interest and continuous variables. Mixed effects regression modeling techniques may be employed to study the effects of drug group and time of withdrawal on changes in blood pressure over time under anesthesia. An alpha value of 0.05 will be used to assess statistical significance.
An estimated total of 530 patients would be required to detect a significant difference (alpha=0.05, power 80%) between patients that were taking ACEI/ARBs prior to surgery compared to patients that were not, assuming the proportion of patients experiencing moderate hypotension was 0.60 compared to 0.46 for those whose last dose of ACEI/ARB was <10 hours and greater than or equal to 10 hours respectively. . We propose to recruit a total of n= 650 including dropouts and loss to follow ups.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/11/2016

Actual

13/02/2017

Date of last participant enrolment

Anticipated

1/06/2020

Actual

2/12/2020

Date of last data collection

Anticipated

2/06/2020

Actual

31/12/2020

Sample size

Target

530

Accrual to date

Final

600

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Recruitment hospital [2]

Caboolture Hospital - Caboolture

Recruitment postcode(s) [1]

4032 - Chermside

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Anaesthesia, The Prince Charles Hospital

Address [1]

The Prince Charles Hospital, Rode Road, Chermside, QLD 4032

Country [1]

Australia

Primary sponsor type

Individual

Name

Usha Gurunathan

Address

Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital, Human Research and Ethics committee

Ethics committee address [1]

The Prince Charles Hospital, Rode Road, Chermside, Queensland- 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/08/2016

Approval date [1]

13/09/2016

Ethics approval number [1]

HREC/16/QPCH/280

Summary

Brief summary

Ambulatory surgical procedures are increasingly being performed worldwide; patient complexities such as obesity, advanced age along with other medical conditions will be frequently encountered. Major perioperative morbidites or mortalities are reported to occur once in every 1000-day surgical cases according to a recent large review on approximately 250,000 cases. One of the significant predictors for adverse outcomes was hypertension. Increasing number of patients on ACEI and ARBs are seen undergoing day surgery procedures.  While we have strong recommendations about preoperative beta-blockers, the evidence on these antihypertensives that act on the renin- angiotensin pathway is insufficient and controversial There is insufficient evidence on whether ACEI and ARBs should be continued or ceased before ambulatory surgeries.  As there have been limited data in terms of recommendations on ACEI/ARB agonist in ambulatory surgeries, more research seems necessary to provide evidence on the risks of continuation these drugs, in terms of both high and low blood pressure responses.
Primary aim: To investigate the association between i)Preoperative angiotensinogen converting enzyme inhibitor (ACEI) and ii)angiotensin II receptor blocker (ARB) therapy and perioperative blood pressure changes in patients undergoing ambulatory surgical procedures
Secondary aim: 1. To study the haemodynamic influence of continuation of other antihypertensive agents. 2. To examine the effect of hemodynamic fluctuations on the quality of recovery and complication rates
Following ethics committee approval, preoperative data from the consented patients that undergo day surgery procedures will be collected from patient records and face-to-face interview. Patients are allowed to follow their medication order as per the surgical/ anaesthetic teams’ instructions. No specific instruction on the antihypertensive treatment shall be given for this study.  The preoperative data collected include but not limited to the antihypertensive therapy details and the time of last dose of medication. Management of the case will be left to the anaesthetic team involved. The details on the anaesthetic management, intraoperative hemodynamic changes and postoperative recovery details will be collected at the end of surgery.
Endpoints measured:
Primary: Significant hypotension b. Change in mean perioperative systolic blood pressure from mean pre-operative measures. c) Variability in systolic blood pressure d) Preoperative hypertensionSecondary outcomes: Length of stay in recovery room. Unplanned readmission or any major surgical or medical complications, quality of recovery within 24 hours of the day-surgery procedure, correlation between the primary outcome measures Vs type antihypertensive agents and the timing of discontinuation in patients on monotherapy.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Usha Gurunathan

Address

The Prince Charles Hospital, Rode Road, Chermside, Queensland,- 4032

Country

Australia

Phone

+61 7 3139 4000

Fax

[email protected]

Contact person for public queries

Name

Adrian Roe

Address

Department of Urology, The Prince Charles Hospital, Rode Road, Chermside, Queensland,- 4032

Country

Australia

Phone

+61 7 3139 4000

Fax

[email protected]

Contact person for scientific queries

Name

Usha Gurunathan

Address

The Prince Charles Hospital, Rode Road, Chermside, Queensland,- 4032

Country

Australia

Phone

+61 7 3139 4000

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Individual participant data is not meaningful as the data will be deidentified and only the haemodynamics readings will be considered for analysis

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically