Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy

July 25, 2016 updated by: Dr Douglas Taupin, The Canberra Hospital

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:

(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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Observation only
Active Comparator: Active
Infusion of 1 liter normal saline before sedated colonoscopy
Drug: Infusion of 1 litre of normal saline before colonoscopy
Prehydration with normal saline

What is the study measuring?

Primary Outcome Measures

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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Canberra Hospital

Investigators

  • Principal Investigator: Douglas R Taupin, MBBS, PhD, The Canberra Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 28, 2006

First Submitted That Met QC Criteria

March 28, 2006

First Posted (Estimate)

March 29, 2006

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/05.851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonic Diseases

Clinical Trials on Infusion of 1 litre of normal saline before colonoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe