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Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy

Primary Purpose

Colonic Diseases

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Infusion of 1 litre of normal saline before colonoscopy
Sponsored by
The Canberra Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonic Diseases focused on measuring Colonoscopy, Rehydration, Sedation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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

Sites / Locations

  • The Canberra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Active

Arm Description

Observation only

Infusion of 1 liter normal saline before sedated colonoscopy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2006
Last Updated
July 25, 2016
Sponsor
The Canberra Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00308152
Brief Title
Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy
Official Title
Randomised, Controlled Trial of Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Canberra Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases
Keywords
Colonoscopy, Rehydration, Sedation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Observation only
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Infusion of 1 liter normal saline before sedated colonoscopy
Intervention Type
Drug
Intervention Name(s)
Infusion of 1 litre of normal saline before colonoscopy
Intervention Description
Prehydration with normal saline
Primary Outcome Measure Information:
Title
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
Title
Colonoscopy completion rates. Raw completion rates, with no allowance for failed bowel preparation or technical difficulties, will be used.
Title
The number of subjects reaching criteria for discharge at 30 minutes after arrival in the recovery area
Title
Comfort and satisfaction scores: discomfort during colonoscopy, discomfort after colonoscopy, satisfaction with sedation, overall satisfaction
Title
Time taken to resume normal activities
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas R Taupin, MBBS, PhD
Organizational Affiliation
The Canberra Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16285939
Citation
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.
Results Reference
background
PubMed Identifier
12709694
Citation
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.
Results Reference
background
PubMed Identifier
2193561
Citation
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.
Results Reference
background
PubMed Identifier
11063163
Citation
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.
Results Reference
background
PubMed Identifier
14723606
Citation
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.
Results Reference
background
PubMed Identifier
12024134
Citation
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.
Results Reference
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Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy

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