Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing ERCP

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

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.

Study Overview

• Status: Completed
• Conditions: Sedation in ERCP
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Ahmed Mohamed Soliman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 .	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
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate during procedure	Change in heart rate during procedure	intraoperative
Change in MAP	Change in MAP during procedure	intraoperative
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
Duration to recovery after the end of procedure	Duration to recovery after the end of procedure	first 2hours postoperative
Total doses of both agents used	Total doses of Propofol or Dexmedetomidine used	intraoperative

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: cancer; ERCP; Dexmedetomidine; sedation; propofol; Endoscopic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: MS-211-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No