Acid-base Balance in Patients Undergoing Colonoscopy

Mahidol University

Status and phase: Unknown; Phase 1

Conditions: Bowel Preparation; Colonoscopy

Treatments: Drug: Lactated Ringer's solution; Drug: Acetate Ringer's solution; Drug: Normal saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01250886

456/2553(EC2)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Normal saline solution

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline solution

Lactated Ringer's solution

Active Comparator group

Description:

Lactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.

Treatment:

Drug: Lactated Ringer's solution

Acetate Ringer's solution

Active Comparator group

Description:

Acetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.

Treatment:

Drug: Acetate Ringer's solution