Acid-base Balance in Patients Undergoing Colonoscopy
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Purpose
The purpose of this study is to determine whether fluid administration in patients undergoing colonoscopy should affect acid-base disorder in term of the strong ion differences.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy Bowel Preparation |
Drug: Lactated Ringer's solution Drug: Normal saline solution Drug: Acetate Ringer's solution |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intravenous Fluid Administration in Patients Undergoing Colonoscopy: Double Blind, Randomised Clinical Trial of Underlying Acid-base Derangement |
- Number of Patients with Acid-base disorder as a Measure of Strong Ion Difference. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]The strong ion difference (SID) is calculated by means of the differences between the positively and negatively charged strong ions in plasma. The strong ion difference affected by bowel preparation and intravenous fluid administration during colonoscopy.
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Normal saline solution
Blood sample is obtained from patient in either forearm immediately before a Normal saline solution administered on the same site. The volume of fluid administration is calculated by means of Holliday and Segar formula.
|
Drug: Normal saline solution
Normal saline solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
Other Name: NSS
|
|
Active Comparator: Lactated Ringer's solution
Lactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
|
Drug: Lactated Ringer's solution
Lactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
Other Name: LRS
|
|
Active Comparator: Acetate Ringer's solution
Acetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
|
Drug: Acetate Ringer's solution
Acetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
Other Name: ARS
|
Detailed Description:
This is a prospective, double-blinded, randomized control trial. The study enrolls 90 consecutive outpatients, well-prepared bowel, scheduled to undergo routine colonoscopy for screening, surveillance, or diagnosis of colorectal diseases. At the outpatient clinic, the co-researcher invites patients who meet the inclusion criteria to join the study. The process of the project is explained to the interested patients in details before an informed consent is obtained and the first blood sample is conducted.
On the day of colonoscopy, all participants are randomized equally into three groups: Normal saline solution (NSS, n = 30) as control group, lactated Ringer's solution (LRS, n = 30) and acetated Ringer's solution (ARS, n = 30) as treatment groups. The second blood sample is obtained from patients via 20-gauge needle in either forearm immediately before an allocated intravenous (IV) fluid administered on the same site. The volume of fluid is calculated by means of Holliday and Segar formula.
The colonoscopy under total intravenous anesthesia is performed between 9:00 a.m. and 3:00 p.m. At the end of colonoscopy, the patients spontaneously wake up in the recovery room. After they gain conscious and all vital signs are stable; the intravenous fluid is off and the third blood sample is taken in the other forearm. After completion of the procedure, the patient is advised to follow the discharge instructions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- male or non-pregnant
- non-lactating female out-patient scheduled for routine colonoscopy
- over 18 years of age
- eligible for taking PEG or NaP for bowel preparation, and willing to sign informed consent.
Exclusion Criteria:
- insulin-dependant diabetes
- renal insufficiency (creatinine >2.0 mg⁄ dL)
- renal dialysis
- uncontrolled congestive heart failure (American Heart Association Classification III or IV congestive heart failure)
- unstable angina
- untreated cardiac arrhythmia
- ileus and⁄or acute obstruction or perforation
- ileostomy
- presence of a colostomy
- history of a partial colon resection
- active gastrointestinal bleeding.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Phongthara Vichitvejpaisal", Professor, Mahidol University |
| ClinicalTrials.gov Identifier: | NCT01250886 History of Changes |
| Other Study ID Numbers: | 456/2553(EC2) |
| Study First Received: | November 29, 2010 |
| Last Updated: | September 12, 2012 |
| Health Authority: | Thailand: Ethical Committee |
ClinicalTrials.gov processed this record on May 16, 2013