Restritive and Liberal Fluid Management and Colonoscopy
NCT ID: NCT05522127
Last Updated: 2023-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-10-11
2023-03-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Group R (Restrictive)
Group R (Restrictive, 2ml/kg 0.9% NaCl during colonoscopy)
Colonoscopy
Colonoscopy
Sedoanalgesia
Ketamine, fentanil, midazolam, propofol
Group L (Liberal )
Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy)
Colonoscopy
Colonoscopy
Sedoanalgesia
Ketamine, fentanil, midazolam, propofol
Interventions
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Colonoscopy
Colonoscopy
Sedoanalgesia
Ketamine, fentanil, midazolam, propofol
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
Yes
Sponsors
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Baskent University
OTHER
Responsible Party
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Yonca Özvardar Pekcan
MD, Anesthesia and Reanimation specialist, principal investigator
Principal Investigators
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Yonca Özvardar Pekcan
Role: PRINCIPAL_INVESTIGATOR
Baskent University
Locations
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Baskent University Zubeyde Hanim Practice and Research Center
Izmir, Karşıyaka, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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
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.
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.
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.
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.
Other Identifiers
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KA22/87
Identifier Type: -
Identifier Source: org_study_id
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