Trial Review

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00308152




Registration number
NCT00308152
Ethics application status
Date submitted
28/03/2006
Date registered
29/03/2006
Date last updated
27/07/2016

Titles & IDs
Public title
Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy
Scientific title
Randomised, Controlled Trial of Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy
Secondary ID [1] 0 0
11/05.851
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Diseases 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Infusion of 1 litre of normal saline before colonoscopy

No Intervention: Control - Observation only

Active Comparator: Active - Infusion of 1 liter normal saline before sedated colonoscopy


Treatment: Drugs: Infusion of 1 litre of normal saline before colonoscopy
Prehydration with normal saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of subjects with documented hypotension (systolic blood pressure [BP] = 95 mmHg for 1 or more automatic BP measures taken at 3 minute intervals), during colonoscopy or the recovery period
Timepoint [1] 0 0
Primary outcome [2] 0 0
Colonoscopy completion rates. Raw completion rates, with no allowance for failed bowel preparation or technical difficulties, will be used.
Timepoint [2] 0 0
Primary outcome [3] 0 0
The number of subjects reaching criteria for discharge at 30 minutes after arrival in the recovery area
Timepoint [3] 0 0
Primary outcome [4] 0 0
Comfort and satisfaction scores: discomfort during colonoscopy, discomfort after colonoscopy, satisfaction with sedation, overall satisfaction
Timepoint [4] 0 0
Primary outcome [5] 0 0
Time taken to resume normal activities
Timepoint [5] 0 0
Primary outcome [6] 0 0
Where relevant, adverse events such as post-procedure nausea, syncope, and prolonged recovery time, will be recorded in both arms of the study for comparison.
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
- Aged 18 or older

- Able to provide informed consent

- Booked for outpatient colonoscopy, where appointment has been generated by
Gastroenterology Unit bookings staff.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Booked for anaesthetist-supervised colonoscopy because of previous sedation
difficulties or significant co-morbidity (American Society of Anesthesiology Class III
or IV)

- Subjects requiring dialysis

- Subjects receiving parenteral nutrition

- Subjects with current congestive cardiac failure

- Subjects with conditions preventing placement and accurate use of the automatic blood
pressure cuff on the left arm, such as morbid obesity or lymphoedema

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2008
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 0 0
2605 - Garran

Funding & Sponsors
Primary sponsor type
Other
Name
The Canberra Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Colonoscopy and sedation are frequently accompanied by hypotension, which reduces the amount
of sedation able to be employed. Blood pressure is restored by the infusion of intravenous
normal saline. Prophylactic infusion of normal saline may enhance the colonoscopy completion
rate, and patient comfort during colonoscopy and during the recovery from colonoscopy.

The investigators propose randomising consenting adult patients attending outpatient
colonoscopy to one of two treatment arms:

(i) A control arm

(ii) A treatment arm, with pre-hydration with an infusion of 1.0 litre of normal saline
immediately prior to colonoscopy.

Outcome measures include colonoscopy completion rates, hypotension during or after
colonoscopy, and patient ratings of comfort and satisfaction.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00308152
Trial related presentations / publications
Rex DK, Heuss LT, Walker JA, Qi R. Trained registered nurses/endoscopy teams can administer propofol safely for endoscopy. Gastroenterology. 2005 Nov;129(5):1384-91. doi: 10.1053/j.gastro.2005.08.014.
Heuss LT, Schnieper P, Drewe J, Pflimlin E, Beglinger C. Risk stratification and safe administration of propofol by registered nurses supervised by the gastroenterologist: a prospective observational study of more than 2000 cases. Gastrointest Endosc. 2003 May;57(6):664-71. doi: 10.1067/mge.2003.191.
Schrier RW. Body fluid volume regulation in health and disease: a unifying hypothesis. Ann Intern Med. 1990 Jul 15;113(2):155-9. doi: 10.7326/0003-4819-113-2-155.
Ristikankare M, Julkunen R, Laitinen T, Wang SX, Heikkinen M, Janatuinen E, Hartikainen J. Effect of conscious sedation on cardiac autonomic regulation during colonoscopy. Scand J Gastroenterol. 2000 Sep;35(9):990-6. doi: 10.1080/003655200750023093.
Chen SC, Rex DK. Review article: registered nurse-administered propofol sedation for endoscopy. Aliment Pharmacol Ther. 2004 Jan 15;19(2):147-55. doi: 10.1111/j.0269-2813.2004.01833.x.
Sipe BW, Rex DK, Latinovich D, Overley C, Kinser K, Bratcher L, Kareken D. Propofol versus midazolam/meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists. Gastrointest Endosc. 2002 Jun;55(7):815-25. doi: 10.1067/mge.2002.124636. Erratum In: Gastrointest Endosc 2002 Aug;56(2):324.
Public notes

Contacts
Principal investigator
Name 0 0
Douglas R Taupin, MBBS, PhD
Address 0 0
The Canberra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00308152