Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04177927 |
| Other study ID # |
053 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2019 |
| Est. completion date |
October 1, 2020 |
Study information
| Verified date |
October 2021 |
| Source |
Istanbul Medeniyet University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Does Endtidalcarbondioxide Monitoring in Gastrointestinal Endoscopy Have a Clinical
Advantage?
Description:
This study will be randomized prospectively and conducted in Sancaktepe Prof.Dr. Dr. İlhan
Varank Training and Research Hospital Endoscopy Unit. After the approval from institute
ethics committee, and obtaining written informed consent, sixty patients with ASA I-II who
underwent lumbar spinal surgery between 18 and 65 years of age were included in the study.
Patients with existing heart and lung disease, liver and kidney failure, morbidly obese,
using psychiatric drugs, having malignancy, pregnant and lactating patients will not be
included in the study. All patients admitted to the endoscopy unit will be monitorized for
noninvasive arterial blood and BiS (Bispectral Index) monitorization. Some of the patients
will undergo standard monitoring HR (heart rate) and SpO2 (peripheral oxygen saturation).
Other patients will be placed in appropriate nasal cannula Capnostream 20p / Coviden for
etCO2 (End tidal CO2), RR (Respitarory rate), SpO2 and PR (heart rate) monitorization. Prior
to endoscopic intervention, fentanyl 1mcgr/kg iv and propofol 1mg/kg iv will be administered
to patients for sedation. During the procedure, the BiS value will be arranged 60-85 and
propofol 10-30 mg will be administered intravenously if necessary. If sedation is
insufficient, fentanyl 25 mcg iv will be added. After baseline values are recorded mean
arterial pressure, BiS values, etCO2, RR, SpO2, PR, iPi (Integrated Pulmonary Index) score
values will be recorded at 5 minute intervals after the procedure has started. At the end of
the procedure, ODI (Oxygenesaturation Index), A/Hr (hourly apnea) values will be recorded.
Undesirable events like apnea, desaturation will be intervened and duration of it will be
recorded. Apnea is described as the breathing stops (ETCO2 = 0mmHg, RR = 0 ) for more than 30
seconds and desaturation is described the fall in SpO2 value below 4% of initial value
lasting for at least 4 minutes. When apnea and desaturation are seen, verbal stimulation, jaw
lifting maneuver and oxygen flow will be increased. If the apnea and desaturation periods of
the patients are prolonged or the SpO2 value falls below 10% of the initial value despite the
interventions, the procedure will be terminated and necessary procedures will be performed to
ensure airway safety and the study will be terminated.
Patients who have completed the endoscopic intervention will be taken to the recovery unit
and the Fast-tracking recovery score will be calculated at 10 minute intervals in the first
hour. The time that the fast-tracking score is 14 will be recorded. Patients with two
consecutive Fast-tracking recovery score values 14 will be discharged. Patients will be
called after 24-48 hours and questioned if they have symptoms such as abdominal distension,
fever, nausea and vomiting, dizziness and weakness. The satisfaction score to the patient
will be questioned; 1:not satisfied at all, 2: not satisfied, 3: neutral, 4:satisfied, 5:
very satisfied.
