Clinical trial NCT04686448: Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release
Official title: Propofol-Ketamine (Ketofol) Versus Propofol-Fentanyl (Fenofol) as Procedural Sedation for Unilateral Open Carpal Tunnel Release Under Local Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Procedural Sedation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-12-28
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: depth of sedation
timeFrame: from drug injection up to 15 minutes till modified Ramsay sedation scale ≤ 4
Secondary outcomes:
measure: recovery time
timeFrame: up to 30 minutes postoperative
measure: • The total duration of post-anesthesia care unit (PACU) stay (The time from arrival to the PACU to discharge to the ward) according to modified Aldrete score 9
timeFrame: up to 1 hour postoperative
measure: Total propofol consumption by mg
timeFrame: from the start of drug injection till discontinuation of propfol infusion about 1 hour
measure: number of participants with intraoperative complications such as hypotenstion, bradycardia and hypoxia
timeFrame: from the start of drug injection till end of surgery about 1 hour
measure: number of participants with postoperative complications such as postoperative nausea and vomting
timeFrame: within 12 hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: Zagazig University
name: Marwa Zakzouk, MD
role: PRINCIPAL_INVESTIGATOR
References: