Restritive and Liberal Fluid Management and Colonoscopy

Colonoscopy Clinical Trial

Official title:

A Comparison of Restrictive and Liberal Fluid Administration During Elective Colonoscopy Under Sedoanalgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522127
• Other study ID #: KA22/87
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2023
• Source: Baskent University
• Contact: Yonca Özvardar Pekcan
• Phone: +902322411000
• Email: yncapek[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

intraduction and aim In this study, in cases who will undergo elective day colonoscopy under sedoanalgesia; It was planned to investigate the effects of restrictive and liberal fluid administration on hemodynamics, side effects, drug levels, patient satisfaction, recovery and discharge times during the procedure. Methods This study was planned to be conducted as a prospective, randomized (closed envelope method), controlled, double-blind study with 100 adult patients aged 18-65 years in the american sociological association (ASA I-II) risk group who will undergo colonoscopy under sedation-analgesia under elective conditions.Vascular access will be opened and randomly divided into two groups as Group R (Restrictive, 2ml/kg 0.9% Sodium cloride-NaCl during colonoscopy) and Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy). For sedoanalgesia, Midazolam 0.02 mg/kg, Fentanyl 1 μg/kg, Ketamine 0.3 mg/kg will be administered intravenous (IV), followed by 10 mg additional doses of propofol until the Ramsay sedation score (RSS) is 3-4. All colonoscopy procedures will be performed by the same gastroenterologist. Expectations and scientific contributions This research may help to understand the effects of giving or not administering intravenous fluids (restrictive/liberal) prior to the procedure in patients undergoing elective colonoscopy under sedoanalgesia. It can provide hemodynamic stability, reduction in drug doses, reduction of side effects, rapid recovery and discharge, and reduction of costs.

Description:

intraduction and aim Intestinal cleansing and restriction of oral fluid intake in preparation for colonoscopy, which is one of the most frequently performed diagnostic procedures, may cause adverse hemodynamic effects during the procedure. These adverse effects can be prevented by intravenous fluid therapy. In this study, in cases who will undergo elective day colonoscopy under sedoanalgesia; It was planned to investigate the effects of restrictive and liberal fluid administration on hemodynamics, side effects, drug levels, patient satisfaction, recovery and discharge times during the procedure. Methods This study was planned to be conducted as a prospective, randomized (closed envelope method), controlled, double-blind study with 100 adult patients aged 18-65 years in the american sociological association (ASA) I-II risk group who will undergo colonoscopy under sedation-analgesia under elective conditions. The patients will be taken to the endoscopy unit and hemodynamic monitoring will be applied. Vascular access will be opened and randomly divided into two groups as Group R (Restrictive, 2ml/kg 0.9% Sodium cloride-NaCl during colonoscopy) and Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy). For sedoanalgesia, Midazolam 0.02 mg/kg, Fentanyl 1 μg/kg, Ketamine 0.3 mg/kg will be administered intravenous (IV), followed by 10 mg additional doses of propofol until the Ramsay sedation score (RSS) is 3-4. All colonoscopy procedures will be performed by the same gastroenterologist. During the colonoscopy procedure, patients will be given 3L/min oxygen with a face mask. Basal measurement values; heart rate, systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, peripheral oxygen saturation (SpO2), respiratory rate and RSS will be recorded at regular intervals after sedation until the end of the colonoscopy attempt. Total midazolam, fentanyl, propofol, and ketamine doses, induction time, colonoscopy time, cecum intubation time, recovery time, and discharge time will be recorded. Possible hypoventilation, apnea, airway obstruction, hypotension, hypertension, arrhythmia, bradycardia, SpO2 falling below 95% and other side effects will be treated and recorded. At the end of the procedure, the satisfaction of the gastroenterologist will be recorded. Patients with an RSS ≥2 will be admitted to the recovery unit, and patients with a postanesthetic discharge score of ≥9 will be sent home with an accompanying person. Recalls about the colonoscopy procedure by calling 24 hours after the procedure; Undesirable effects such as nausea, vomiting, pain, dizziness, drowsiness and satisfaction with the procedure will be questioned. Expectations and scientific contributions This research may help to understand the effects of giving or not administering intravenous fluids (restrictive/liberal) prior to the procedure in patients undergoing elective colonoscopy under sedoanalgesia. It can provide hemodynamic stability, reduction in drug doses, reduction of side effects, rapid recovery and discharge, and reduction of costs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 30, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Signing the informed consent form

2. Having irritable bowel disease, suspected colitis, unexplained iron deficiency and planning colonoscopy for screening

3. Between the ages of 18-65

4. According to the Physical Condition Classification of the American Society of Anesthesiologists, ASA I (a healthy person who does not cause normal systemic disorders, does not have a disease or systemic problem other than intestinal pathology) or ASA II (Person with mild systemic disorder due to a cause requiring intervention or another disease)

Exclusion Criteria:

1. Not signing the informed consent form

2. Not between the ages of 18-65

3. Having epileptic seizures

4. The use of drugs that affect the nervous system

5. Having a history of allergic reaction to study drugs

6. Long-term use of sedatives or sedatives

7. Receiving general anesthesia in the last 7 days

8. Having adrenocortical insufficiency (hormone deficiency)

9. Pregnancy

10. Having a psychiatric disorder

11. Having irritable bowel disease

12. Presence of nausea, vomiting or dizziness before the procedure

13. Being overweight

14. Having a bad general condition

15. Having had bowel surgery

16. Being in the risky patient group (>ASA II)

17. Alcohol addiction, inappropriate usage

18. Multiple biopsies during the procedure, unwanted bleeding, changes in the amount of fluid to be given

Related Conditions & MeSH terms

• Colonoscopy
• Intravenous Infusions
• Sedoanalgesia

Intervention

Other:
• Colonoscopy
Colonoscopy
• Sedoanalgesia
Ketamine, fentanil, midazolam, propofol

Locations

Country	Name	City	State
Turkey	Baskent University Zubeyde Hanim Practice and Research Center	Izmir	Karsiyaka

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

6. Indrakrishnan I and Varatharajah T. Management of Endoscopy Patients' Hydration Status during National Shortage of Intravenous Fluids. J Gastroenterol Liver Dis 2016; 1: 1001

Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a. — View Citation

das Neves JF, das Neves Araujo MM, de Paiva Araujo F, Ferreira CM, Duarte FB, Pace FH, Ornellas LC, Baron TH, Ferreira LE. Colonoscopy sedation: clinical trial comparing propofol and fentanyl with or without midazolam. Braz J Anesthesiol. 2016 May-Jun;66(3):231-6. doi: 10.1016/j.bjane.2014.09.014. Epub 2016 Mar 12. — View Citation

Leslie K, Allen M, Lee A, Clarke P. A randomized-controlled trial of high- or low-volume intravenous Plasma-Lyte((R)) to prevent hypotension during sedation for colonoscopy. Can J Anaesth. 2016 Aug;63(8):952-61. doi: 10.1007/s12630-016-0672-4. Epub 2016 May 18. — View Citation

Leslie K, Tay T, Neo E. Intravenous fluid to prevent hypotension in patients undergoing elective colonoscopy. Anaesth Intensive Care. 2006 Jun;34(3):316-21. doi: 10.1177/0310057X0603400314. — View Citation

Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available. — View Citation

Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656. — View Citation

Trummel JM, Chandrasekhara V, Kochman ML. Anesthesia for Colonoscopy and Lower Endoscopic Procedures. Anesthesiol Clin. 2017 Dec;35(4):679-686. doi: 10.1016/j.anclin.2017.08.007. — View Citation

Tuncali B, Pekcan YO, Celebi A, Zeyneloglu P. Addition of low-dose ketamine to midazolam-fentanyl-propofol-based sedation for colonoscopy: a randomized, double-blind, controlled trial. J Clin Anesth. 2015 Jun;27(4):301-6. doi: 10.1016/j.jclinane.2015.03.017. Epub 2015 Mar 20. — View Citation

Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE; American Society of Colon and Rectal Surgeons; American Society for Gastrointestinal Endoscopy; Society of American Gastrointestinal and Endoscopic Surgeons. A consensus document on bowel preparation before colonoscopy: prepared by a task force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Gastrointest Endosc. 2006 Jun;63(7):894-909. doi: 10.1016/j.gie.2006.03.918. No abstract available. Erratum In: Gastrointest Endosc. 2006 Jul;64(1):154. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of systolic blood pressure in restrictive and liberal patients in colonosopy under sedoanalgesia.	Systolic blood pressure will be recoded.	During colonoscopy
Primary	Comparison of diastolic blood pressure in restrictive and liberal patients in colonosopy	Diastolic blood pressure will be recoded.	During colonoscopy
Primary	Comparison of heart rate in restrictive and liberal patients in colonosopy	Heart rate will be recoded.	During colonoscopy
Primary	Comparison of spO2 in restrictive and liberal patients in colonosopy	spO2 will be recoded.	During colonoscopy
Primary	Comparison of procedure times in restrictive and liberal patients in colonosopy	Procedure times will be recoded.	During colonoscopy
Primary	Comparison of total anaesthetic doses in restrictive and liberal patients in colonosopy	Total anaesthetic doses will be recoded.	During colonoscopy
Primary	Comparison of nose and vomiting and other effects in restrictive and liberal patients in colonosopy	Side effects will be recorded	24 hours
Primary	Comparison of sedation levels in restrictive and liberal patients in colonosopy	Ramsey and modified post anaesthetic discharge score level will be recorded.	24 hours
Secondary	Patient satisfaction	Patient satisfaction will be assessed using a three point scale (satisfactory, moderate, not satisfactory) at the end of the procedure and after 24 hours via phone call. The patients will also be asked whether they have experienced any side effects (nausea, vomiting, abdominal pain, hallucination, double vision, etc.), and whether they would like to have the same sedoanalgesia procedure in the future colonoscopy procedures or not.	24 hours
Secondary	Gastroenterologist satisfaction	At the end of the procedure, the gastroenterologist's opinion about our sedoanalgesia method will be evaluated.using a three point scale (satisfactory, moderate or unsatisfactory)..	24 hours