Skip to main content
OpenTrials
Completed

NCT Number: NCT06409104

Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing ERCP

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Mohamed Soliman

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

Drug

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.

Primary outcomes

  1. Bispectral Index sedation Score

    Time frame: intraoperative

    >90 indicates an awake patient; 71-90, mild to moderate sedation; 61-70, deep sedation; and 40-60, general anesthesia

Secondary outcomes

  1. Change in heart rate during procedure

    Time frame: intraoperative

    Change in heart rate during procedure

  2. Change in MAP

    Time frame: intraoperative

    Change in MAP during procedure

  3. Pain during procedure according to Facial Pain Rating Scale

    Time frame: first 2hours postoperative

    Pain during procedure according to Facial Pain Rating Scale (FPS;0 no pain-10 maximum pain)

  4. Duration to recovery after the end of procedure

    Time frame: first 2hours postoperative

    Duration to recovery after the end of procedure

  5. Total doses of both agents used

    Time frame: intraoperative

    Total doses of Propofol or Dexmedetomidine used

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 10, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.