drugset / Trial / NCT04686448

Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release

NCT04686448

Phase 1/2 Unknown 56 enrolled Zagazig University
RandomizedParallel-groupDouble-blindTreatment

Summary

There are different methods of anesthesia for CTR surgery. Procedural sedation will allow rapid recovery and fewer complications than regional or general anesthesia (GA). Attempts have been made in the past to use additives with propofol to reduce its dose. Ketofol (ketamine/propofol combination) was used for procedural sedation and analgesia. Ketamine and propofol administered in combination have offered effective sedation for spinal anesthesia and for gynecologic, ophthalmologic, and cardiovascular procedures in all age groups. The opposing hemodynamic and respiratory effects of each drug may enhance the utility of this drug combination, increasing both safety and efficacy and allowing reduction in the dose of propofol required to achieve sedation. Propofol alone had a significantly greater number of apnea with desaturation (SpO2 \< 90%) episodes. Further, it has been shown that during colonoscopies, propofol in combination with fentanyl provided similar patient satisfaction with shorter recovery times even at lower depths of sedation as compared to propofol. The addition of fentanyl to propofol has been shown to result in better operator feasibility with no difference in recovery time, cognitive impairment, or complications as compared to the use of propofol only for sedation.

Timeline

Start
2021-01-01
Primary completion
2021-04-01
Completion
2021-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 1 ug/kg Intravenous
Comparator Ketamine Small molecule 0.5 mg/kg Intravenous
Comparator Propofol Small molecule 0.05 mg/kg Intravenous

Indications

No indication recorded.