Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy

Study Overview
=================
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.

Official Title
-----------------
Randomised, Controlled Trial of Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy

Conditions
-----------------
Colonic Diseases

Intervention / Treatment
-----------------
* Drug: Infusion of 1 litre of normal saline before colonoscopy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehydration, Colonoscopy, Sedation