Colonoscopy Clinical Trial
Official title:
A Comparison of Restrictive and Liberal Fluid Administration During Elective Colonoscopy Under Sedoanalgesia
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.
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 |
Country | Name | City | State |
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Turkey | Baskent University Zubeyde Hanim Practice and Research Center | Izmir | Karsiyaka |
Lead Sponsor | Collaborator |
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Baskent University |
Turkey,
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
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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
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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 |
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