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Restritive and Liberal Fluid Management and Colonoscopy

A Comparison of Restrictive and Liberal Fluid Administration During Elective Colonoscopy Under Sedoanalgesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05522127
Enrollment
100
Registered
2022-08-30
Start date
2022-10-11
Completion date
2023-03-30
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravenous Infusions, Colonoscopy, Sedoanalgesia

Keywords

Sedoanalgesia, Colonoscopy, Intravenous Infusions

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.

Interventions

OTHERColonoscopy

Colonoscopy

Ketamine, fentanil, midazolam, propofol

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of sedation levels in restrictive and liberal patients in colonosopy24 hoursRamsey and modified post anaesthetic discharge score level will be recorded.
Comparison of total anaesthetic doses in restrictive and liberal patients in colonosopyDuring colonoscopyTotal anaesthetic doses will be recoded.
Comparison of nose and vomiting and other effects in restrictive and liberal patients in colonosopy24 hoursSide effects will be recorded
Comparison of systolic blood pressure in restrictive and liberal patients in colonosopy under sedoanalgesia.During colonoscopySystolic blood pressure will be recoded.
Comparison of diastolic blood pressure in restrictive and liberal patients in colonosopyDuring colonoscopyDiastolic blood pressure will be recoded.
Comparison of heart rate in restrictive and liberal patients in colonosopyDuring colonoscopyHeart rate will be recoded.
Comparison of spO2 in restrictive and liberal patients in colonosopyDuring colonoscopyspO2 will be recoded.
Comparison of procedure times in restrictive and liberal patients in colonosopyDuring colonoscopyProcedure times will be recoded.

Secondary

MeasureTime frameDescription
Gastroenterologist satisfaction24 hoursAt 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 satisfaction24 hoursPatient 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactYonca Özvardar Pekcan
yncapek@gmail.com+902322411000
Backup ContactBahattin Tuncali
tuncali.bahattin@gmail.com+902322411000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026