Colonic DiseasesPhase 2NCT00308152
Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy
A Phase 2 study testing Infusion of 1 litre of normal saline before colonoscopy in people with Colonic Diseases, run by The Canberra Hospital at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Diseases
- What is being tested?
- Infusion of 1 litre of normal saline before colonoscopy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2006to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- Able to provide informed consent
- Booked for outpatient colonoscopy, where appointment has been generated by Gastroenterology Unit bookings staff.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Canberra Hospital
Garran, Australian Capital Territory, 2605
About this study
Official title: Randomised, Controlled Trial of Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy
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:
Read more
(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.
Read the detailed description
Outpatient colonoscopy is a generally well-tolerated elective procedure. Colonoscopy completion rate is governed in part by patient comfort, which is enhanced by adequate sedation. In addition, comfort following colonoscopy determines timely recovery from the procedure and return to usual activities.
Colonoscopy and sedation are frequently accompanied by hypotension (systolic blood pressure less than 100 mm Hg), which reduces the amount of sedation able to be employed. Where apparent, blood pressure is restored by infusion of intravenous normal saline. We have observed that hypotension is relatively common and may be present at or shortly after the commencement of the procedure, suggesting that many patients undergoing colonoscopy have reduced blood volume. Therefore, prophylactic infusion of normal saline may enhance colonoscopy completion rate, and patient comfort during colonoscopy and during recovery from colonoscopy.
We propose randomising consenting adult patients attending outpatient colonoscopy to one of two treatment arms:
(i) A control arm, with standard sedation and monitoring during colonoscopy, and infusion of normal saline if systolic BP ≤ 95 mmHg for more than 3 minutes (two observation periods) until completion of the procedure;
(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.
- Conditions
- Colonic Diseases
- Being tested
- Infusion of 1 litre of normal saline before colonoscopy
- Keywords
- Colonoscopy, Rehydration, Sedation
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of 1 litre of normal saline before colonoscopyDrug
Prehydration with normal saline
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Observation only |
| Active | Active comparator | Infusion of 1 liter normal saline before sedated colonoscopy Receives: Drug: Infusion of 1 litre of normal saline before colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Colonoscopy completion rates. Raw completion rates, with no allowance for failed bowel preparation or technical difficulties, will be used.
The number of subjects reaching criteria for discharge at 30 minutes after arrival in the recovery area
Comfort and satisfaction scores: discomfort during colonoscopy, discomfort after colonoscopy, satisfaction with sedation, overall satisfaction
Time taken to resume normal activities
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Canberra Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Douglas Taupin, The Canberra Hospital
- Investigators
- Douglas R Taupin, MBBS, PhD, Principal investigator, The Canberra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308152
- Sponsor's protocol ID
- 11/05.851
- Status last verified
- Jul 2016
- First submitted
- 28 Mar 2006
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 16285939Heuss 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.
PubMed 12709694Schrier 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.
PubMed 2193561Ristikankare 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.
PubMed 11063163Chen 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.
PubMed 14723606Sipe 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.
PubMed 12024134
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled Trial of Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy
- ClinicalTrials.gov ID
- NCT00308152
- Acronym / sponsor ID
- 11/05.851
- Conditions
- Colonic Diseases
- Keywords
- Colonoscopy, Rehydration, Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Canberra HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Outpatient colonoscopy is a generally well-tolerated elective procedure. Colonoscopy completion rate is governed in part by patient comfort, which is enhanced by adequate sedation. In addition, comfort following colonoscopy determines timely recovery from the procedure and return to usual activities.
Colonoscopy and sedation are frequently accompanied by hypotension (systolic blood pressure less than 100 mm Hg), which reduces the amount of sedation able to be employed. Where apparent, blood pressure is restored by infusion of intravenous normal saline. We have observed that hypotension is relatively common and may be present at or shortly after the commencement of the procedure, suggesting that many patients undergoing colonoscopy have reduced blood volume. Therefore, prophylactic infusion of normal saline may enhance colonoscopy completion rate, and patient comfort during colonoscopy and during recovery from colonoscopy.
We propose randomising consenting adult patients attending outpatient colonoscopy to one of two treatment arms:
(i) A control arm, with standard sedation and monitoring during colonoscopy, and infusion of normal saline if systolic BP ≤ 95 mmHg for more than 3 minutes (two observation periods) until completion of the procedure;
(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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Observation only |
| Active | Active comparator | Drug: Infusion of 1 litre of normal saline before colonoscopyInfusion of 1 liter normal saline before sedated colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or older
- Able to provide informed consent
- Booked for outpatient colonoscopy, where appointment has been generated by Gastroenterology Unit bookings staff.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion of 1 litre of normal saline before colonoscopyPrehydration with normal saline | Drug | Active |
Primary outcome
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
Colonoscopy completion rates. Raw completion rates, with no allowance for failed bowel preparation or technical difficulties, will be used.
The number of subjects reaching criteria for discharge at 30 minutes after arrival in the recovery area
Comfort and satisfaction scores: discomfort during colonoscopy, discomfort after colonoscopy, satisfaction with sedation, overall satisfaction
Time taken to resume normal activities
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Background: PubMed 16285939Rex 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.
- Background: PubMed 12709694Heuss 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.
- Background: PubMed 2193561Schrier 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.
- Background: PubMed 11063163Ristikankare 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.
- Background: PubMed 14723606Chen 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.
- Background: PubMed 12024134Sipe 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.
- Individual participant dataSharing planned: No
Related trials for Colonic Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas R Taupin, MBBS, PhD principal investigator
The Canberra Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infusion of 1 litre of normal saline before colonoscopy in people with Colonic Diseases, run by The Canberra Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308152, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.