NCT05473949

Ketofol Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients.

Ketofol (Ketamine and Propofol) Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Centro Hospitalar Universitário Lisboa Norte · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a double blind randomized controlled trial. The investigators randomized ASA III and IV patients who underwent cholangiopancreatography. The investigators gave Propofol or Ketofol and compared the outcomes. The primary outcome was security (respiratory depression / hypoventilation).

Detailed description

Randomization is performed by the nurse responsible for preparing the anesthesia drugs. The nurse randomly removes an envelope from a previously prepared container with as many envelopes as the number of patients calculated for the sample. Each envelope, which will be sealed, contains the branch to which the patient belongs (propofol or ketofol) and instructions for the preparation of the respective drugs. The sample was calculated for a significance level of 5% and a test power of 95%, assuming that, on average, the primary outcome of this study - respiratory depression - is observed in 3% of the population undergoing sedation with ketofol and to 25% of patients undergoing sedation with propofol. The result of the calculation includes 51 patients for each branch of the study (considering the one-tailed hypothesis test). Data collection is expected to take place over 5 months, taking place between October 2016 and March 2017. The study is designed to be blinded to the patient and the anesthesiologist/investigator. The anesthesia nurse, after preparing the drugs according to the instructions on the envelope containing the branch of the study to which the patient belongs, should label each syringe in a non-committal manner. Statistical analysis was performed using the IBM SPSS Statistics 27. It will not be necessary to resort to the monitoring committee, since no method or technique different from the one usually practiced will be applied

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients	Use of 1% Propofol (Indution dose: 0.75mg/kg Maintenance dose: 6-7mg/kg/h) for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
DRUG	Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients	use of Ketofol (1% Propofol + 5% Ketamine with a ratio 1/4) Indution dose: 0.75mg/kg Maintenance dose: 6-7mg/kg/h) for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-03-31
• Completion: 2017-03-31
• First posted: 2022-07-26
• Last updated: 2022-08-09