Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing ERCP

Sedation in ERCP Clinical Trial

Official title:

Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography: Randomized Single Blinded Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06409104
• Other study ID #: MS-211-2023
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2024
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation in ERCP

Intervention

Drug:
• Propofol
will receive 1-2 mgkg-1 propofol injection over 30s followed by of propofol a 0.05 to 0.1 mg /kg/min infusion
• Dexmedetomidine
will receive dexmedetomidine at a loading dose of 1 µg/kg over 10 min, followed by a 0.2-0.7-µg/kg/h infusion.

Locations

Country	Name	City	State
Egypt	Ahmed Mohamed Soliman	Giza

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bispectral Index sedation Score	>90 indicates an awake patient; 71-90, mild to moderate sedation; 61-70, deep sedation; and 40-60, general anesthesia	intraoperative
Secondary	Change in heart rate during procedure	Change in heart rate during procedure	intraoperative
Secondary	Change in MAP	Change in MAP during procedure	intraoperative
Secondary	Pain during procedure according to Facial Pain Rating Scale	Pain during procedure according to Facial Pain Rating Scale (FPS;0 no pain-10 maximum pain)	first 2hours postoperative
Secondary	Duration to recovery after the end of procedure	Duration to recovery after the end of procedure	first 2hours postoperative
Secondary	Total doses of both agents used	Total doses of Propofol or Dexmedetomidine used	intraoperative