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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: PK general anesthesia
* Drug: PFK combination


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF group<br>The first group will undergo general anesthesia using Fentanyl and Propofol. | Drug: PK general anesthesia<br>* Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).<br>|
| Experimental: PFK group<br>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. | Drug: PFK combination<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transient decrease in oxygen saturation | the investigators will record any episodes of transient reduction of oxygen saturation. | 1 hour | 
| Blood pressure stability | the investigators will record changes in blood pressure after induction of anesthesia | 1 hour | 
| Recovery time | the investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Endoscopy, Colonoscopy