Goal Directed Propofol Sedation With Magnesium Sulphate Versus Dexmedetomidine for ERCP Procedure

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive longer endoscopic procedure. It is performed in remote locations under a continuum of anesthetic depth, ranging from conscious to deep sedation leading to general anesthesia.

Propofol sedation for (ERCP) procedures is the most popular current technique that has generated controversy in the medical field. Propofol can be safely administered because of its shorter half-life which results in a shorter recovery time than conventional sedation (opioid and/or benzodiazepine) that makes it widely used for sedation in many gastrointestinal procedures including ERCP. However, because of its narrow therapeutic window, the level of conscious sedation can easily go deeper from moderately deep sedation to near general anesthesia. Therefore, propofol as a sole agent can cause oversedation and apnea. Depth of sedation could be estimated better when target effect concentration of propofol is titrated by using bispectral index monitoring device(BIS).Targeting BIS within a specific range ensures additional safety during the procedure. Scores between 60-80 have been recommended for sedation. Propofol requirement can be reduced with addition of adjuvants (eg. Ketamine, Magnesium sulfate and Dexmedetomidine). Most adjuncts have analgesic properties with opioid and anesthetic sparing effects, without clinically significant respiratory depression.

Dexmedetomidine, is a selective alpha 2 agonist; it has sedative, amnestic, and analgesic properties. It is a useful addition to a propofol/remifentanil anesthetic combination as it reduced their requirements intraoperatively and can help supplement analgesia postoperatively. Its combination with propofol was proved to provide satisfactory anesthesia for upper gastrointestinal (GI)) endoscopy in obstructive sleep apnea patients .

Magnesium can also act as an adjuvant in analgesia due to its properties as calcium channel blocker and N-methyl-D-aspartate antagonists .It was suggested to be a near ideal intravenous (IV) adjunct to propofol/ remifentanil based total anesthesia in gynaecology patients .

Hypothesis of this study is that Magnesium sulfate can have a propofol sparing effect during ERCP procedures guided by BIS monitoring as efficient as dexmedetomidine but with less cost and complications together with more patient and doctor satisfaction in addition to better patient outcome.

Conditions

• Lack of Drug Action

Interventions

DRUG

Dexmedetomidine

added to propofol sedation

DRUG

Magnesium Sulphate

added to propofol sedation

Sponsors & Collaborators

• Theodor Bilharz Research Institute

  lead OTHER

Principal Investigators

• Hend H Kamel, Professor · Theodor Bilharz Research Institute

• Maher F Mahmoud, Professor · Kasr El Aini hospital,Faculty of medicine, Cairo University,

• Eslam A Mohamed, Lecturer · Kasr El Aini hospital,Faculty of medicine, Cairo University,

• Nabaweya M Kamal, Professor · Theodor Bilharz Research Institute

• Mohammed A Maher, Lecturer · Theodor Bilharz Research Institute

• Ahmed S Abd El Azeem, Residant · Theodor Bilharz Research Institute

• Khalda G Radwan, Professor · Theodor Bilharz Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2016-09-30

Completion

2016-11-30

Countries

• Egypt

Study Locations