Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy

NCT00308152 | Completed Phase 2

• 1 other identifier: 11/05.851
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Diseases

Keywords

Colonoscopy; Rehydration; Sedation

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (2)

Control

NO INTERVENTION

Observation only

Active

ACTIVE COMPARATOR

Infusion of 1 liter normal saline before sedated colonoscopy

Drug: Infusion of 1 litre of normal saline before colonoscopy

Interventions

Infusion of 1 litre of normal saline before colonoscopy DRUG

Prehydration with normal saline

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or older
• Able to provide informed consent
• Booked for outpatient colonoscopy, where appointment has been generated by Gastroenterology Unit bookings staff.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Canberra Hospital: lead

Study Sites (1)

The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Related Publications (6)

• 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. doi: 10.1053/j.gastro.2005.08.014.

  PMID: 16285939 BACKGROUND

• 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. doi: 10.1067/mge.2003.191.

  PMID: 12709694 BACKGROUND

• Schrier RW. Body fluid volume regulation in health and disease: a unifying hypothesis. Ann Intern Med. 1990 Jul 15;113(2):155-9. doi: 10.7326/0003-4819-113-2-155.

  PMID: 2193561 BACKGROUND

• 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. doi: 10.1080/003655200750023093.

  PMID: 11063163 BACKGROUND

• Chen SC, Rex DK. Review article: registered nurse-administered propofol sedation for endoscopy. Aliment Pharmacol Ther. 2004 Jan 15;19(2):147-55. doi: 10.1111/j.0269-2813.2004.01833.x.

  PMID: 14723606 BACKGROUND

• 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. doi: 10.1067/mge.2002.124636.

  PMID: 12024134 BACKGROUND

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Douglas R Taupin, MBBS, PhD

  The Canberra Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Specialist

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 29, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)