Clinical trial NCT05522127: Restritive and Liberal Fluid Management and Colonoscopy
Official title: A Comparison of Restrictive and Liberal Fluid Administration During Elective Colonoscopy Under Sedoanalgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intravenous Infusions
Colonoscopy
Sedoanalgesia
Keywords: Sedoanalgesia
Colonoscopy
Intravenous Infusions
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of systolic blood pressure in restrictive and liberal patients in colonosopy under sedoanalgesia.
timeFrame: During colonoscopy
measure: Comparison of diastolic blood pressure in restrictive and liberal patients in colonosopy
timeFrame: During colonoscopy
measure: Comparison of heart rate in restrictive and liberal patients in colonosopy
timeFrame: During colonoscopy
measure: Comparison of spO2 in restrictive and liberal patients in colonosopy
timeFrame: During colonoscopy
measure: Comparison of procedure times in restrictive and liberal patients in colonosopy
timeFrame: During colonoscopy
measure: Comparison of total anaesthetic doses in restrictive and liberal patients in colonosopy
timeFrame: During colonoscopy
measure: Comparison of nose and vomiting and other effects in restrictive and liberal patients in colonosopy
timeFrame: 24 hours
measure: Comparison of sedation levels in restrictive and liberal patients in colonosopy
timeFrame: 24 hours
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 24 hours
measure: Gastroenterologist satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Baskent University Zubeyde Hanim Practice and Research Center
state: Karşıyaka
Study officials:
affiliation: Baskent University
name: Yonca Özvardar Pekcan
role: PRINCIPAL_INVESTIGATOR
References:
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