Trial Review

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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] 287769 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypotension during elective colonoscopy 296654 0
Condition category
Condition code
Anaesthesiology 296878 296878 0 0
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] 293163 0
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] 296481 0
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] 296481 0
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] 318561 0
Systolic blood pressure <90 mm Hg. Blood pressure will be measured oscillometrically.
Timepoint [1] 318561 0
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] 318562 0
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] 318562 0
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] 318563 0
Duration of hypotension. Blood pressure will be measured oscillometrically
Timepoint [3] 318563 0
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] 318564 0
Nausea and vomiting by patient report during recovery from sedation ("yes" or "no")
Timepoint [4] 318564 0
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] 318565 0
Headache by patient report ("yes" or "no")
Timepoint [5] 318565 0
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] 318566 0
Dizziness by patient report ("yes" or "no").
Timepoint [6] 318566 0
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] 318567 0
Drowsiness by patient report. ("yes" or "no")
Timepoint [7] 318567 0
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] 318568 0
Thirst on a 100-mm visual analog scale.
Timepoint [8] 318568 0
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] 318569 0
Patient satisfaction on a 5-point Likert scale.
Timepoint [9] 318569 0
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] 318570 0
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] 318570 0
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?
No
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] 4538 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 12155 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 292307 0
Hospital
Name [1] 292307 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital
Country [1] 292307 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Melbourne Health
Grattan St
Parkville, VIC, 3050
Country
Australia
Secondary sponsor category [1] 290987 0
None
Name [1] 290987 0
None
Address [1] 290987 0
None
Country [1] 290987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293779 0
Melbourne Health Research Ethics Committee
Ethics committee address [1] 293779 0
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Ethics committee country [1] 293779 0
Australia
Date submitted for ethics approval [1] 293779 0
21/11/2014
Approval date [1] 293779 0
16/12/2014
Ethics approval number [1] 293779 0
2014.219
Ethics committee name [2] 293780 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 293780 0
Ethics committee country [2] 293780 0
Australia
Date submitted for ethics approval [2] 293780 0
Approval date [2] 293780 0
10/01/2015
Ethics approval number [2] 293780 0
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 61266 0
Prof Kate Leslie
Address 61266 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 61266 0
Australia
Phone 61266 0
+61-3-93427540
Fax 61266 0
Email 61266 0
[email protected]
Contact person for public queries
Name 61267 0
Prof Kate Leslie
Address 61267 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 61267 0
Australia
Phone 61267 0
+61-3-93427540
Fax 61267 0
Email 61267 0
[email protected]
Contact person for scientific queries
Name 61268 0
Prof Kate Leslie
Address 61268 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 61268 0
Australia
Phone 61268 0
+61-3-93427540
Fax 61268 0
Email 61268 0
[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
SourceTitleYear of PublicationDOI
EmbaseA randomized-controlled trial of high- or low-volume intravenous Plasma-Lyte to prevent hypotension during sedation for colonoscopy.2016https://dx.doi.org/10.1007/s12630-016-0672-4
N.B. These documents automatically identified may not have been verified by the study sponsor.