A study to establish whether administering intravenous fluids or not during a colonoscopy make a difference to the outcomes of adult patients.
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https://www.omicsdi.org/dataset/ecrin-mdr-crc/2470763
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Interventions: The patients will be randomised to either receive or not receive IV crystalloid fluids during their routine colonoscopy. The intervention treatment in this study is the administration of IV fluids; therefore the intervention arm is recieving fluids. The fluids will be administered by anaesthetic staff through an IV cannula (the IV cannula will be placed in the patient regardless of whether they participate in the trial or not).
All participants who agree to be a part of the study will be asked a series of questions before and after the procedure to gauge their tolerance and outcomes. All participants will also have a blood sample analysed before and after their procedure, and will be appropriately consented as to the risks involved. All participants in this study will be recieving a form of procedural anaesthesia, a black bag will be placed over the intra-venous fluid set up as well to ensure blinding.
The treatment is not personalized nor is it tailored to the individuals, and will be administered according to their randomization. There will be no specific monitoring of adherence, withdrawal after randomization has been recorded.
Primary outcome(s): Hypotensive episodes – this will be defined by a drop in the systolic BP of >20% during the procedure. This outcome will be assessed by comparing their recorded blood pressure at the begingn of the procedure with the recordings made during the procedure at 5 minute intervals. It will be performed by automated cuff linked to the anaesthetic machine.[At the time of the intervention];Electrolyte change - Sodium, Urea, Creatinine)
This will be assessed as a composite primary outcome[These will be collected pre and post procedure by venipuncture. The will be analyzed to assess for evidence statistically significant differences in the patient’s hydration with/without hydration during the procedure.]
Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety
创建时间:
2017-02-15



