Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release

NCT ID: NCT04686448

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-05-01

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

Conditions

Procedural Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

propofol-ketamine

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 Type: ACTIVE_COMPARATOR

propofol-ketamine

Intervention Type: DRUG

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

propofol-fentanyl

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

Group Type: ACTIVE_COMPARATOR

propofol-fentanyl

Intervention Type: DRUG

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

Interventions

propofol-ketamine

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

Intervention Type: DRUG

propofol-fentanyl

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

Intervention Type: DRUG

Other Intervention Names

ketofol; fenofol

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marwa Mahmoud Abd Allah Zakzouk

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa Zakzouk, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Zagazig University

Zagazig, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Marwa Zakzouk, MD

Role: CONTACT

dr.marwa.zu@gmail.com

01004178761 ext. 002

Al shaimaa Kamel, MD

Role: CONTACT

AlshaimaaKamel80@yahoo.com

01005593169 ext. 002

Facility Contacts

Marwa Zakzouk, MD

Role: primary

dr.marwa.zu@gmail.com

01004178761 ext. 002

Alshaimaa Kamel, MD

Role: backup

Alshaimaakamel80@yahoo.com

01005593169 ext. 002

Other Identifiers

6556

Identifier Type: -

Identifier Source: org_study_id