Restritive and Liberal Fluid Management and Colonoscopy

Not Applicable

Recruiting

• Conditions: Intravenous Infusions; Colonoscopy; Sedoanalgesia
• Interventions: Other: Colonoscopy; Other: Sedoanalgesia

• Registration Number: NCT05522127
• Lead Sponsor: Baskent University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-27
• Study First Posted: 2022-08-30
• Study Start: 2022-10-11
• Primary Completion: 2022-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group R (Restrictive)	Sedoanalgesia	Group R (Restrictive, 2ml/kg 0.9% NaCl during colonoscopy)
Group L (Liberal )	Colonoscopy	Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy)
Group R (Restrictive)	Colonoscopy	Group R (Restrictive, 2ml/kg 0.9% NaCl during colonoscopy)
Group L (Liberal )	Sedoanalgesia	Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy)

Primary Outcome Measures

Name	Time	Method
Comparison of systolic blood pressure in restrictive and liberal patients in colonosopy under sedoanalgesia.	During colonoscopy	Systolic blood pressure will be recoded.
Comparison of spO2 in restrictive and liberal patients in colonosopy	During colonoscopy	spO2 will be recoded.
Comparison of diastolic blood pressure in restrictive and liberal patients in colonosopy	During colonoscopy	Diastolic blood pressure will be recoded.
Comparison of total anaesthetic doses in restrictive and liberal patients in colonosopy	During colonoscopy	Total anaesthetic doses will be recoded.
Comparison of heart rate in restrictive and liberal patients in colonosopy	During colonoscopy	Heart rate will be recoded.
Comparison of nose and vomiting and other effects in restrictive and liberal patients in colonosopy	24 hours	Side effects will be recorded
Comparison of procedure times in restrictive and liberal patients in colonosopy	During colonoscopy	Procedure times will be recoded.
Comparison of sedation levels in restrictive and liberal patients in colonosopy	24 hours	Ramsey and modified post anaesthetic discharge score level will be recorded.

Secondary Outcome Measures

Name	Time	Method
Gastroenterologist satisfaction	24 hours	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)..
Patient satisfaction	24 hours	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.

Trial Locations

Locations (1)

Baskent University Zubeyde Hanim Practice and Research Center; 🇹🇷 İzmir, Karşıyaka, Turkey