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

The Use of Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures: a Prospective Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04473846
Enrollment
200
Registered
2020-07-16
Start date
2020-08-31
Completion date
2021-06-30
Last updated
2020-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Anesthesia, Endoscopy, Colonoscopy

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.

Interventions

DRUGPK general anesthesia

Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).

DRUGPFK 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.

Sponsors

University of Jordan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Transient decrease in oxygen saturation1 hourthe investigators will record any episodes of transient reduction of oxygen saturation.
Blood pressure stability1 hourthe investigators will record changes in blood pressure after induction of anesthesia
Recovery time2 hoursthe investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness.

Countries

Jordan

Contacts

Primary ContactAbdelkarim S AlOweidi
akaloweidi@hotmail.com+962795712121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026