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A study comparing two sedation drug combinations in colonoscopy patients to evaluate comfort, safety, and recovery

A Randomised Controlled Double-Blinded Study Comparing Patient Satisfaction and Hemodynamic Responses Between Ketamine-Propofol Combination and Fentanyl-Propofol During Conscious Sedation and Analgesia in Colonoscopy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103486
Enrollment
106
Registered
2026-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: K635- Polyp of colon

Interventions

Intervention1: Group PF Propofol Fentanyl combination: Midazolam 0.01 milligrams per kilogram before induction followed by Bolus dose of Propofol 0.75 milligrams per kilogram and Fentanyl 1 micrograms

Sponsors

Rakshana S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 and older of both gender Physical status of American Society of Anaesthesiologists ASA grade 1,2 Patients undergoing elective day care colonoscopy procedure Well controlled hypertensive patients without any recent episode of hypertensive episodes

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Patient satisfaction during colonoscopy measured using a five point Likert scale. Where 1 indicates not at all satisfied and 5 indicates extremely satisfied. Assessment will be done after the procedure when the patient is alert and cooperative.Timepoint: Once the patient is alert and cooperative in the post anaesthesia care unit

Secondary

MeasureTime frame
Incidence of hemodynamic events. Hypotension defined as a decrease of more than thirty percent from baseline systolic blood pressure. Bradycardia defined as heart rate less than fifty beats per minuteTimepoint: Intraoperative period- continuous monitoring;Incidence of respiratory events. Desaturation defined as oxygen saturation less than ninety two percent. Apnea defined as cessation of breathing for more than twenty secondsTimepoint: Intraoperative period- continuous monitoring;Incidence of psychological emergence reactions in the post anaesthesia care unit.Timepoint: Post anaesthesia care unit- Every 1 minute for the first 5 minutes, then every 5 minutes until discharge;Incidence of nausea & vomiting in the post anaesthesia care unit.Timepoint: Post anaesthesia care unit-Every 1 minute for the first 5 minutes, then every 5 minutes until discharge;Total propofol dose consumed in milligrams from induction to end of procedure.Timepoint: Durning the entire Intraoperative period;Endoscopist satisfaction rated on a ten point Likert scale.Timepoint: 5 minutes Post procedure;Level of sedation during the procedure assessed every five minutes using Observer s Assessment of Alertness & Sedation scale.Timepoint: Every 5 minutes from the start of the procedure;Recovery time defined as the time taken between the end of procedure & achieving a modified Aldrete score of nine or above.Timepoint: From end of procedure to discharge from Post anaesthesia care unit;Quality of recovery assessed using QoR 15 predesigned questionnaire.Timepoint: Once the patient is alert & cooperative in Post anaesthesia care unit;Patient recall of intra procedural events such as pain or other experiencesTimepoint: Once the patient is alert & cooperative in Post anaesthesia care unit

Countries

India

Contacts

Public ContactRAKSHANA S

Sri Ramachandra Institute for Higher Education and Research

Rampond@gmail.com919380537411

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026