ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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

ACTRN12615001288516

Ethics application status

Approved

Date submitted

2/11/2015

Date registered

26/11/2015

Date last updated

26/11/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Fluid therapy to prevent hypotension in patients having colonoscopy

Scientific title

The effect of two volumes of intravenous Plasma-Lyte 148 (20 mL/Kg and 2 mL/kg) on the incidence of a decrease in systolic blood pressure of greater than or equal to 25% from baseline during intravenous sedation for elective colonoscopy in adult patients.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Hypotension during elective colonoscopy

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intravenous Plasma-Lyte 148 20 mL/kg administered before sedation for elective colonoscopy

Intervention code [1]

Treatment: Other

Comparator / control treatment

Intravenous Plasma-Lyte 148 2 mL/kg administered before sedation for elective colonoscopy

Control group

Active

Outcomes

Primary outcome [1]

Number of patients with a decrease in systolic blood pressure greater than or equal to 25% from baseline. Blood pressure will be measured oscillometrically.

Timepoint [1]

Blood pressure will be measured every 2.5 min during sedation for colonoscopy. Intravenous fluid administration will be completed before commencement of sedation.

Secondary outcome [1]

Systolic blood pressure <90 mm Hg. Blood pressure will be measured oscillometrically.

Timepoint [1]

Blood pressure will be measured every 2.5 min during sedation for colonoscopy. Intravenous fluid administration will be completed before commencement of sedation.

Secondary outcome [2]

Treatment for hypotension during sedation. Attending anaesthetists will decide if the blood pressure needs to be treated and how it will be treated (i.e. vasopressors or further intravenous fluid administration). The anaesthetist/blinded observer will record whether treatment is given, and what the treatment is, on the case report form.

Timepoint [2]

Intravenous fluid administration will be completed before commencement of sedation. Blood pressure will be measured every 2.5 min during sedation for colonoscopy. Hypotension will be defined as any blood pressure that is measured during sedation that provokes treatment by the attending anaesthetist.

Secondary outcome [3]

Duration of hypotension. Blood pressure will be measured oscillometrically

Timepoint [3]

Intravenous fluid administration will be completed before commencement of sedation. Blood pressure will be measured every 2.5 min during sedation for colonoscopy. Duration of hypotension during sedation will be calculated from measurements made during sedation.

Secondary outcome [4]

Nausea and vomiting by patient report during recovery from sedation ("yes" or "no")

Timepoint [4]

In the post anaesthesia care unit. The typical post anaesthesia care unit stay is 20 minutes. The patient was asked once at the end of the post anaesthesia care unit stay.

Secondary outcome [5]

Headache by patient report ("yes" or "no")

Timepoint [5]

In the post anaesthesia care unit. The typical post anaesthesia care unit stay is 20 minutes. The patient was asked once at the end of the post anaesthesia care unit stay.

Secondary outcome [6]

Dizziness by patient report ("yes" or "no").

Timepoint [6]

In the post anaesthesia care unit. The typical post anaesthesia care unit stay is 20 minutes. The patient was asked once at the end of the post anaesthesia care unit stay.

Secondary outcome [7]

Drowsiness by patient report. ("yes" or "no")

Timepoint [7]

In the post anaesthesia care unit. The typical post anaesthesia care unit stay is 20 minutes. The patient was asked once at the end of the post anaesthesia care unit stay.

Secondary outcome [8]

Thirst on a 100-mm visual analog scale.

Timepoint [8]

Asked twice. Once after the administration of the intervention and comparator.
Once at the end of the post anaesthesia care unit stay. The typical post anaesthesia care unit stay is 20 minutes.

Secondary outcome [9]

Patient satisfaction on a 5-point Likert scale.

Timepoint [9]

In the post anaesthesia care unit. The typical post anaesthesia care unit stay is 20 minutes. The patient was asked once at the end of the post anaesthesia care unit stay.

Secondary outcome [10]

Cost of intravenous therapy. The cost is equal to the cost of the intravenous fluid giving set and the cost of the intravenous fluids. Hospital pricing lists were used to determine costs.

Timepoint [10]

The cost will be calculated after patient discharge.

Eligibility

Key inclusion criteria

Presenting for elective colonoscopy with or without gastroscopy
Successful oral bowel preparation
Planned intravenous sedation by an anaesthetist
Able to communicate in English
No prior intravenous fluid administration
No planned intravenous fluid administration
No contraindication to intravenous fluid administration (e.g. uncontrolled heart failure or end-stage renal failure)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Presenting for emergency colonoscopy
Unsuccessful oral bowel preparation
Planned intravenous sedation by a non-anaesthetist
Unable to communicate in English
Prior intravenous fluid administration
Planned intravenous fluid administration
Contraindication to intravenous fluid administration (e.g. uncontrolled heart failure or end-stage renal failure)

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation results are concealed in sequentially numbered opaque envelopes which are not opened until consent has been obtained.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

23/03/2015

Date of last participant enrolment

Anticipated

Actual

2/09/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

150

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3050 - Royal Melbourne Hospital

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Anaesthesia and Pain Management, Royal Melbourne Hospital

Address [1]

Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Melbourne Health

Address

Melbourne Health
Grattan St
Parkville, VIC, 3050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Research Ethics Committee

Ethics committee address [1]

Royal Melbourne Hospital
Grattan St
Parkville VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2014

Approval date [1]

16/12/2014

Ethics approval number [1]

2014.219

Ethics committee name [2]

Monash University Human Research Ethics Committee

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

10/01/2015

Ethics approval number [2]

CF14/3971-2014002058

Summary

Brief summary

Colonoscopy is one of the most common medical procedures performed in Australia. Patients having colonoscopy take oral bowel preparation and fast before their procedure. During their procedure they receive sedative drugs. All these factors can cause low blood pressure during the procedure. In addition they can be associated with nausea, vomiting, headache, dizziness, drowsiness, thirst and low satisfaction with care after the procedure. We are testing whether a high volume (2o mL/kg) of a balanced salt solution given intravenously before the procedure will prevent low blood pressure and unwanted postoperative symptoms when compared with a low volume (2 mL/kg) of the same solution. We are testing this in adult patients presenting for elective colonoscopy at our hospital.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Kate Leslie

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61-3-93427540

Fax

[email protected]

Contact person for public queries

Name

Kate Leslie

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61-3-93427540

Fax

[email protected]

Contact person for scientific queries

Name

Kate Leslie

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61-3-93427540

Fax

[email protected]

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	A randomized-controlled trial of high- or low-volume intravenous Plasma-Lyte to prevent hypotension during sedation for colonoscopy.	2016	https://dx.doi.org/10.1007/s12630-016-0672-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically