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Comparison of Sedative Efficacy Between Propofol Ketamine vs Propofol Fentanyl for Colonoscopy in Patients at Sikhoraphum Hospital A Randomized Controlled Trial

Comparison of Sedative Efficacy Between Propofol Ketamine vs Propofol Fentanyl for Colonoscopy in Patients at Sikhoraphum Hospital A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260707003
Enrollment
110
Registered
2026-07-07
Start date
2026-03-26
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Colorectal diseases Colonoscopy sedation Procedural sedation Colonoscopy Sedation Propofol Ketamine Fentanyl Ketofol Fenofol

Interventions

Participants will receive intravenous ketamine 0.5 mg/kg combined with propofol 1 mg/kg for sedation during colonoscopy. Additional doses of the study medication may be administered to maintain the ta
Experimental Drug,Active Comparator Drug
Propofol Ketamine (Ketofol),Propofol Fentanyl (Fenofol)

Sponsors

Dr.Nutthineenart Tongdee
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective colonoscopy at Sikhoraphum Hospital. 2. American Society of Anesthesiologists Physical Status Classification I to III. 3. Able to understand the study procedures and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Known allergy or hypersensitivity to propofol, ketamine, fentanyl, egg, soy, or soybean products. 2. Pregnancy or breastfeeding. 3. History of psychiatric disorders or neurological conditions that may interfere with sedation assessment. 4. Severe cardiovascular or respiratory disease. 5. Severe hepatic or renal impairment. 6. Uncontrolled hypertension. 7. Use of sedative or hypnotic medications within 24 hours before colonoscopy. 8. History of seizure disorders or brain metastasis. 9. Chronic pain syndrome or regular opioid use. 10. Any condition considered by the investigator to make participation unsafe.

Design outcomes

Primary

MeasureTime frame
Sedation quality During colonoscopy procedure Ramsay Sedation Score

Secondary

MeasureTime frame
Recovery time Post procedure recovery period Time to achieve Aldrete Recovery Score of 9 or higher,Hemodynamic stability Baseline and every 5 minutes during colonoscopy Mean arterial pressure, heart rate and oxygen saturation,Adverse events During procedure and recovery period Incidence of hypotension, desaturation, apnea, airway obstruction and emergence reactions,Patient satisfaction Sixty minutes after colonoscopy Three point satisfaction scale,Endoscopist satisfaction Immediately after colonoscopy Three point satisfaction scale

Countries

Thailand

Contacts

Public ContactNutthineenart Tongdee

Sikhoraphum Hospital

nutthinee2322@gmail.com044561341

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026