Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release

Zagazig University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Procedural Sedation

Treatments: Drug: propofol-fentanyl; Drug: propofol-ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04686448

6556

Details and patient eligibility

About

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.

Full description

Sample size: assuming that the sedation using modified Ramasy sedation score was 6±0.01 in ketofol group versus 5.38±0.87 in fenofol group so the sample will be 56 patients, 28 patients in each group using OPENEPI at power 80 and CI 95 A computer-generated randomization table divided patients into 2 equal groups.

• Group (K) (n=28): patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.
• Group (F) (n=28): patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.

The depth of sedation will be assessed by modified Ramsay sedation

Enrollment: 56 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 21-55 years old.
• Sex: both sex (males or females).
• Physical status: ASA I & II.
• BMI: 25-30 kg/m2.
• Type of operation: elective unilateral CTR under local anesthesia.
• Written informed consent from the patient.
• Cooperative patient.

Exclusion criteria

• Patient refusal.
• Altered mental status.
• Patients with known history of allergy to study drugs.
• Severe hepatic, renal, Cardiovascular and respiratory diseases.
• Patients on regular sedative or pain killer medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

propofol-ketamine

Active Comparator group

Description:

patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4

Treatment:

Drug: propofol-ketamine

propofol-fentanyl

Active Comparator group

Description:

patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4

Treatment:

Drug: propofol-fentanyl