Intravenous Saline Pre-Hydration in Patients Undergoing Outpatient Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
The Canberra Hospital
ClinicalTrials.gov Identifier:
NCT00308152
First received: March 28, 2006
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Conscious Sedation
Procedure: Infusion of 1 litre of normal saline before colonoscopy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomised, Controlled Trial of Intravenous Saline Pre-Hydration in Patients Undergoing Outpatient Colonoscopy

Resource links provided by NLM:


Further study details as provided by The Canberra Hospital:

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.

Estimated Enrollment: 1000
Study Start Date: February 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308152

Locations
Australia, Australian Capital Territory
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Sponsors and Collaborators
The Canberra Hospital
Investigators
Principal Investigator: Douglas R Taupin, MBBS, PhD The Canberra Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Dr Douglas Taupin, The Canberra Hospital
ClinicalTrials.gov Identifier: NCT00308152     History of Changes
Other Study ID Numbers: 11/05.851
Study First Received: March 28, 2006
Last Updated: May 6, 2008
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by The Canberra Hospital:
Colonoscopy
Rehydration
Sedation

ClinicalTrials.gov processed this record on April 22, 2014