Ankara Etlik City Hospital
Altındağ, Ankara, 06000, Turkey (Türkiye)
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NCT Number: NCT07809230
"This prospective observational study aims to evaluate the effects of adding low-dose ketamine (0.25 mg/kg) to standard propofol sedation on hemodynamic stability, sedation depth, and recovery times in adult patients undergoing elective colonoscopy. Sedation depth will be objectively monitored using the Bispectral Index (BIS) alongside clinical scoring. The study observes and compares two standard sedation regimens routinely used in the clinic: propofol alone versus a combination of propofol and low-dose ketamine.
Researchers will record intraoperative hemodynamic parameters (mean arterial pressure, heart rate, oxygen saturation) and BIS values at regular intervals from baseline to the end of the procedure. Furthermore, postoperative recovery quality, cognitive function, and discharge readiness will be comprehensively assessed using the Modified Aldrete Score, Post Anesthetic Discharge Scoring System (PADSS), and a computerized Psychomotor Vigilance Test (PVT-B) at specific time points. The total amount of propofol consumed to maintain adequate sedation will also be compared between the two observational cohorts."
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Altındağ, Ankara, 06000, Turkey (Türkiye)
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Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in this group will receive standard propofol sedation titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy
Patients in this group will receive a combination of standard propofol sedation and low-dose ketamine (0.25 mg/kg). Propofol will be titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy
Time frame: Baseline, at induction, and every 3 minutes until the end of the procedure
Evaluation of Mean Arterial Pressure (MAP)
Time frame: Intraoperative (Continuous monitoring from baseline to the end of the procedure)
Objective assessment of sedation depth using the BIS monitor
Time frame: At the end of the procedure
Total amount of propofol (in mg) consumed to maintain adequate sedation (Ramsay Score 2-3)
Contact information is provided by the study sponsor or research team.
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Ankara Etlik City Hospital
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The Effects of Adding Low-Dose Ketamine to Propofol Sedation on Bispectral Index Values, Hemodynamic Stability, and Recovery Time in Patients Undergoing Colonoscopy
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