Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308152
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2006-03-28
Brief Title:
Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy
Sponsor:
The Canberra Hospital
Organization:
The Canberra Hospital
Study Overview
Official Title:
Randomised Controlled Trial of Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10 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
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 10 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 10 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
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 10 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None