Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy

Colonic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308152
• Other study ID #: 11/05.851
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2006
• Last updated: July 25, 2016
• Start date: February 2006
• Est. completion date: May 2008

Study information

• Verified date: July 2016
• Source: The Canberra Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colonic Diseases

Intervention

Drug:
• Infusion of 1 litre of normal saline before colonoscopy
Prehydration with normal saline

Locations

Country	Name	City	State
Australia	The Canberra Hospital	Garran	Australian Capital Territory

Sponsors (1)

Lead Sponsor	Collaborator
The Canberra Hospital

Country where clinical trial is conducted

Australia, 

References & Publications (6)

Chen SC, Rex DK. Review article: registered nurse-administered propofol sedation for endoscopy. Aliment Pharmacol Ther. 2004 Jan 15;19(2):147-55. Review. — View Citation

Heuss LT, Schnieper P, Drewe J, Pflimlin E, Beglinger C. Risk stratification and safe administration of propofol by registered nurses supervised by the gastroenterologist: a prospective observational study of more than 2000 cases. Gastrointest Endosc. 2003 May;57(6):664-71. — View Citation

Rex DK, Heuss LT, Walker JA, Qi R. Trained registered nurses/endoscopy teams can administer propofol safely for endoscopy. Gastroenterology. 2005 Nov;129(5):1384-91. — View Citation

Ristikankare M, Julkunen R, Laitinen T, Wang SX, Heikkinen M, Janatuinen E, Hartikainen J. Effect of conscious sedation on cardiac autonomic regulation during colonoscopy. Scand J Gastroenterol. 2000 Sep;35(9):990-6. — View Citation

Schrier RW. Body fluid volume regulation in health and disease: a unifying hypothesis. Ann Intern Med. 1990 Jul 15;113(2):155-9. Review. — View Citation

Sipe BW, Rex DK, Latinovich D, Overley C, Kinser K, Bratcher L, Kareken D. Propofol versus midazolam/meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists. Gastrointest Endosc. 2002 Jun;55(7):815-25. Erratum in: Gastrointest Endosc 2002 Aug;56(2):324. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Colonoscopy completion rates. Raw completion rates, with no allowance for failed bowel preparation or technical difficulties, will be used.
Primary	The number of subjects reaching criteria for discharge at 30 minutes after arrival in the recovery area
Primary	Comfort and satisfaction scores: discomfort during colonoscopy, discomfort after colonoscopy, satisfaction with sedation, overall satisfaction
Primary	Time taken to resume normal activities
Primary	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.

External Links

•   Three Gastroenterology Specialty Groups Issue Joint Statement on Sedation in Endoscopy