Clinical trial NCT06409104: Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing ERCP
Official title: Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography: Randomized Single Blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation in ERCP
Keywords: ERCP
Endoscopic
cancer
sedation
propofol
Dexmedetomidine
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 202
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * To compare hemodynamic profile of dexmedetomidine and Propfol during sedation in patients undergoing ERCP.
* To study both agents effect on respiratory complications.
* To demonstrate the effect of both drugs on cognitive functions.
* To assess the effect of both drugs on duration of procedure and number of interruptions.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.

Detailed description: Endoscopic retrograde cholangiopancreatography (ERCP) plays a crucial role in the diagnosis and treatment of pancreaticobiliary pathologies, and its use has increased in recent years. The procedure lasts from 30 to 60 position. Patients usually cannot tolerate the procedure because of pain, uncomfortable position, fear, and nausea without adequate sedation; therefore, ERCP is generally performed under moderate to deep sedation or even GA. ERCP under general anesthesia has several limitations. The procedure is often prolonged due to extra time required for patient preparation, induction of anesthesia, tracheal intubation, and recovery. In addition, the cost per procedure is higher. Deep sedation, on the other hand, is an alternative that is used by specific centers under anesthesiologist supervision instead of general anesthesia. Deep sedation has the advantage of offering the extra time required for general anesthesia and better procedure conditions in relation to conscious sedation.

Propofol is a popular drug that is frequently used in day surgery because of its early onset activity, short duration of action, and the fact that the patient regains normal mental functions only minutes after intravenous application. However, an increased dose of propofol may cause undesirable side effects such as hypoxia which is a common occurrence during upper GI endoscopy under sedation with propofol prolonged hypoxia is the most common cause of cardiac arrhythmia and coronary ischemia .Also, propofol lacks adequate analgesic effects to inhibit visceral traction, pain other side effects of propofol include hypotension and apnea.

In recent years, dexmedetomidine has been used as an alternative to Propofol in conscious sedation applications. Because it provides sedation and analgesia but does not cause respiratory depression, dexmedetomidine is considered a suitable drug for operations that are performed under local anesthesia.

According to authors best knowledge, there are no enough studies comparing both drugs in patients undergoing ERCP

Aim of the work The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.

Objectives:

* To compare the hemodynamic profile of dexmedetomidine and Propofol during sedation in patients undergoing ERCP.
* To study both agents effect on respiratory complications.
* To demonstrate the effect of both drugs on cognitive functions.
* To assess the effect of both drugs on the duration of the procedure and the number of interruptions.

Hypothesis:

The investigators hypothesize that dexmedetomidine will provide better sedation and analgesia with fewer side effects when compared to propofol in patients undergoing ERCP.

Eligibility criteria: Inclusion Criteria:

* Age starting from 21 to 60 years.
* Genders eligible for study: males and females
* ASA II-III
* Undergoing ERCP
* 18.5 to 30 kg/m2

Exclusion Criteria:

* Patient refusal
* Known allergy to drugs used in the study.
* Use of any anti-coagulants
* Neurological disorders
* Advanced liver or kidney disease
* Patient with psychiatric disorders

Primary outcomes:
measure: Bispectral Index sedation Score
timeFrame: intraoperative
Secondary outcomes:
measure: Change in heart rate during procedure
timeFrame: intraoperative
measure: Change in MAP
timeFrame: intraoperative
measure: Pain during procedure according to Facial Pain Rating Scale
timeFrame: first 2hours postoperative
measure: Duration to recovery after the end of procedure
timeFrame: first 2hours postoperative
measure: Total doses of both agents used
timeFrame: intraoperative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Mohamed Soliman
Study officials:
References: