Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04686448
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Marwa Mahmoud Abd Allah Zakzouk, Zagazig University

Tracking Information
First Submitted Date  ICMJE December 22, 2020
First Posted Date  ICMJE December 28, 2020
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2020)
depth of sedation [ Time Frame: from drug injection up to 15 minutes till modified Ramsay sedation scale ≤ 4 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2020)
  • recovery time [ Time Frame: up to 30 minutes postoperative ]
    The time from discontinuation of infusion drug to first response to verbal command
  • • 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 [ Time Frame: up to 1 hour postoperative ]
    Modified Aldert score. Assessment items Condition Grade Activity, able to move, voluntarily or on command 4 extremities 2 2 extremities 1 No 0 Breathing Able to breathe deeply & cough freely 2 Dyspnea, shallow or limited breathing 1 Apnea 0 Consciousness Fully awake 2 Arousable on calling 1 Unresponsive 0 Circulation (BP) ±20% of pre-anesthesia level 2
    • 20% to 49% of pre-anesthesia level 1
    • 50% of pre-anesthesia level 0
    SPO2 Maintains SpO2 >92% in ambient air 2 Maintain SpO2 >90% with O2 1 Maintain SpO2 <90% with O2 0 • Patient having a score of 9 or higher is discharged
  • Total propofol consumption by mg [ Time Frame: from the start of drug injection till discontinuation of propfol infusion about 1 hour ]
    intraoperatice total propofol consumption by mg
  • number of participants with intraoperative complications such as hypotenstion, bradycardia and hypoxia [ Time Frame: from the start of drug injection till end of surgery about 1 hour ]
    Intraoperative Complications such as hypotension (a decrease in mean arterial pressure 20% from base line mean arterial pressure, it will be treated with intravenous fluids and incremental doses of ephedrine), bradycardia (a decrease in heart rate 20% from base line heart rate, it will be treated with atropine) and hypoxia (a decrease in O2 saturation below 92%) will be treated with increasing O2 flow
  • number of participants with postoperative complications such as postoperative nausea and vomting [ Time Frame: within 12 hours postoperative ]
    number of participants with postoperative complications such as postoperative nausea and vomting
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release
Official Title  ICMJE Propofol-Ketamine (Ketofol) Versus Propofol-Fentanyl (Fenofol) as Procedural Sedation for Unilateral Open Carpal Tunnel Release Under Local Anesthesia
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Procedural Sedation
Intervention  ICMJE
  • Drug: 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
    Other Name: ketofol
  • 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
    Other Name: fenofol
Study Arms  ICMJE
  • Active Comparator: 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: Drug: propofol-ketamine
  • Active Comparator: 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: Drug: propofol-fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 22, 2020)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marwa Zakzouk, MD 01004178761 ext 002 dr.marwa.zu@gmail.com
Contact: Al shaimaa Kamel, MD 01005593169 ext 002 AlshaimaaKamel80@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04686448
Other Study ID Numbers  ICMJE 6556
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marwa Mahmoud Abd Allah Zakzouk, Zagazig University
Study Sponsor  ICMJE Zagazig University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marwa Zakzouk, MD Zagazig University
PRS Account Zagazig University
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP