Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release

NCT04686448 | Unknown Phase 1

• 1 other identifier: 6556
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Sedation

Outcome Measures

Primary Outcomes (1)

• depth of sedation

  assessed by Modified Ramsay sedation scale. Score Modified Ramsay Sedation Scale Score 1. Awake and alert, minimal or no cognitive impairment 2. Awake but tranquil, purposeful responses to verbal commands at conversational level 3. Appears asleep, purposeful responses to verbal commands at conversational level 4. Appears asleep, purposeful responses to verbal commands but at louder than usual conversational level, requiring light glabellar tap, or both 5. Asleep, sluggish purposeful responses only to loud verbal commands, strong glabellar tap, or both 6. Asleep, sluggish purposeful responses only to painful Stimuli 7. Asleep, reflex withdrawal to painful stimuli only (no purposeful responses) 8. Unresponsive to external stimuli, including pain interpretation: score 1= minimal sedation score 2-4=moderate sedation score 5-7=deep sedation score 8=anesthesia

  from drug injection up to 15 minutes till modified Ramsay sedation scale ≤ 4

Secondary Outcomes (5)

• recovery time

  up to 30 minutes postoperative

• • 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

  up to 1 hour postoperative

• Total propofol consumption by mg

  from the start of drug injection till discontinuation of propfol infusion about 1 hour

• number of participants with intraoperative complications such as hypotenstion, bradycardia and hypoxia

  from the start of drug injection till end of surgery about 1 hour

• number of participants with postoperative complications such as postoperative nausea and vomting

  within 12 hours postoperative

Study Arms (2)

propofol-ketamine

ACTIVE COMPARATOR

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

Drug: propofol-ketamine

propofol-fentanyl

ACTIVE COMPARATOR

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

Drug: propofol-fentanyl

Interventions

propofol-ketamine 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

Also known as: ketofol

propofol-ketamine

propofol-fentanyl 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

Also known as: fenofol

propofol-fentanyl

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Egypt

RECRUITING

Study Officials

• Marwa Zakzouk, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa Zakzouk, MD

CONTACT

01004178761; dr.marwa.zu@gmail.com

Al shaimaa Kamel, MD

CONTACT

01005593169; AlshaimaaKamel80@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: January 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

EG (1)