Restritive and Liberal Fluid Management and Colonoscopy

NCT05522127 | Unknown

• 1 other identifier: KA22/87
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intravenous Infusions; Colonoscopy; Sedoanalgesia

Keywords

Sedoanalgesia; Colonoscopy; Intravenous Infusions

Outcome Measures

Primary Outcomes (8)

• Comparison of systolic blood pressure in restrictive and liberal patients in colonosopy under sedoanalgesia.

  Systolic blood pressure will be recoded.

  During colonoscopy

• Comparison of diastolic blood pressure in restrictive and liberal patients in colonosopy

  Diastolic blood pressure will be recoded.

  During colonoscopy

• Comparison of heart rate in restrictive and liberal patients in colonosopy

  Heart rate will be recoded.

  During colonoscopy

• Comparison of spO2 in restrictive and liberal patients in colonosopy

  spO2 will be recoded.

  During colonoscopy

• Comparison of procedure times in restrictive and liberal patients in colonosopy

  Procedure times will be recoded.

  During colonoscopy

• Comparison of total anaesthetic doses in restrictive and liberal patients in colonosopy

  Total anaesthetic doses will be recoded.

  During colonoscopy

• Comparison of nose and vomiting and other effects in restrictive and liberal patients in colonosopy

  Side effects will be recorded

  24 hours

• 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 Outcomes (2)

• Patient satisfaction

  24 hours

• Gastroenterologist satisfaction

  24 hours

Study Arms (2)

Group R (Restrictive)

ACTIVE COMPARATOR

Group R (Restrictive, 2ml/kg 0.9% NaCl during colonoscopy)

Other: Colonoscopy; Other: Sedoanalgesia

Group L (Liberal )

ACTIVE COMPARATOR

Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy)

Other: Colonoscopy; Other: Sedoanalgesia

Interventions

Colonoscopy OTHER

Colonoscopy

Group L (Liberal ); Group R (Restrictive)

Sedoanalgesia OTHER

Ketamine, fentanil, midazolam, propofol

Group L (Liberal ); Group R (Restrictive)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing the informed consent form
• Having irritable bowel disease, suspected colitis, unexplained iron deficiency and planning colonoscopy for screening
• Between the ages of 18-65
• 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)

You may not qualify if:

• Not signing the informed consent form
• Not between the ages of 18-65
• Having epileptic seizures
• The use of drugs that affect the nervous system
• Having a history of allergic reaction to study drugs
• Long-term use of sedatives or sedatives
• Receiving general anesthesia in the last 7 days
• Having adrenocortical insufficiency (hormone deficiency)
• Pregnancy
• Having a psychiatric disorder
• Having irritable bowel disease
• Presence of nausea, vomiting or dizziness before the procedure
• Being overweight
• Having a bad general condition
• Having had bowel surgery

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Zubeyde Hanim Practice and Research Center

Izmir, Karşıyaka, 35540, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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.

  PMID: 29101957 BACKGROUND

• 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.

  PMID: 25801162 BACKGROUND

• 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.

  PMID: 27108817 BACKGROUND

• 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.

  PMID: 28045707 BACKGROUND

• 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.

  PMID: 16733101 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27194403 BACKGROUND

• 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.

  PMID: 16802483 BACKGROUND

• 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.

  PMID: 4835444 BACKGROUND

• 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.

  PMID: 8534468 BACKGROUND

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Yonca Özvardar Pekcan

  Baskent University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonca Özvardar Pekcan

CONTACT

+902322411000; yncapek@gmail.com

Bahattin Tuncali

CONTACT

+902322411000; tuncali.bahattin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesia and Reanimation specialist, principal investigator

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 30, 2022
• Study Start: October 11, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 30, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)