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Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures.

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ClinicalTrials.gov Identifier: NCT04473846
Recruitment Status : Not yet recruiting
First Posted : July 16, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Abdelkarim Saleh AlOweidi, University of Jordan

Tracking Information
First Submitted Date  ICMJE July 13, 2020
First Posted Date  ICMJE July 16, 2020
Last Update Posted Date July 16, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
  • Transient decrease in oxygen saturation [ Time Frame: 1 hour ]
    the investigators will record any episodes of transient reduction of oxygen saturation.
  • Blood pressure stability [ Time Frame: 1 hour ]
    the investigators will record changes in blood pressure after induction of anesthesia
  • Recovery time [ Time Frame: 2 hours ]
    the investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures.
Official Title  ICMJE The Use of Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures: a Prospective Study
Brief Summary

Conscious sedation provides adequate control of pain and anxiety for the majority of routine endoscopic procedures as well as adequate amnesia. Sedation practices vary widely, with some colonoscopists advocating sedation only for the most difficult cases of colonoscopy, while others prefer using deep sedation or general anaesthesia for colonoscopy. However, many physicians are still using moderate sedation for the majority of patients.

The use of propofol, a short acting anesthetic agent, for conscious sedation provides a considerably more rapid onset of action and shorter recovery time, for which it is believed to be a safe drug of choice for patients undergoing endoscopic procedures. Although propofol cannot be used as a single agent for moderate sedation, it can be effectively titrated to moderate sedation after administration of small doses of narcotics and sedatives.

The aim of this study is to compare between general anesthesia and deep sedation using propofol-fentanyl-ketamine (PFK) preparation in terms of perioperative vital signs, intraoperative awareness, post-operative pain scores, and the use of analgesia postoperatively.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Drug: PK general anesthesia
    Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).
  • Drug: PFK combination
    Each patient received an initial dose of 0.05 ml/kg from the solution, then after waiting for 60 seconds, another 0.05 ml/kg were given. Maintenance was given as boluses of 0.025 ml/kg every three to five minutes.
Study Arms  ICMJE
  • Experimental: PF group
    The first group will undergo general anesthesia using Fentanyl and Propofol.
    Intervention: Drug: PK general anesthesia
  • Experimental: PFK group
    The second group will receive a mixture that consists of Fentanyl, Propofol, and Ketamine. In addition, Lidocaine will be added to reduce the pain on injection caused by Propofol.
    Intervention: Drug: PFK combination
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients who were admitted for endoscopic and colonoscopic procedures.
  • ASA (American Society of Anaesthesiologists physical status) score from 1 to 3.

Exclusion Criteria:

  • patient refusal.
  • urgent and emergency cases, which were not elective procedures.
  • Surgeries that were expected to take a long duration (more than 1.5 hour).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Abdelkarim S AlOweidi +962795712121 akaloweidi@hotmail.com
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04473846
Other Study ID Numbers  ICMJE 67/2020/524
Has Data Monitoring Committee No
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 Abdelkarim Saleh AlOweidi, University of Jordan
Study Sponsor  ICMJE University of Jordan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Jordan
Verification Date July 2020

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