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Trial record 1 of 1 for:    NCT04099693
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A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP (RAGE)

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ClinicalTrials.gov Identifier: NCT04099693
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : April 6, 2022
Information provided by (Responsible Party):
King Abdullah Medical City

Brief Summary:
Currently there no standard sedation techniques for performing ERCP. It is not clear whether sedation administered by anesthetist is better than anesthesia with intratracheal intubation. To clarify which of these sedative methods are better we plan to conduct a randomized trial comparing anesthetist administered sedation with general anesthesia in patients with ASA ≤3.

Condition or disease

Detailed Description:

ERCP is a relatively complex and lengthy endoscopic procedure. It is increasingly performed in elderly patients with multiple comorbidities and carries serious complications including death in about 0.33% of patients. An important aspect of endoscopy is sedation. The role of sedation is to make the procedure tolerable and acceptable to the patient by reducing anxiety and discomfort. It ensures that the patient is relatively still to avoid injury and enhance the chances of an efficient and successful procedure. Hence, adequate and appropriate sedation is of utmost importance to maximize patient comfort and minimize adverse events in ERCP.

The debate between anesthetist and gastroenterologist continues, as there is dearth of evidence evaluating the best form of sedative technique for ERCP.

Three prospective studies have tried to compare AAS with general anesthesia. Despite the fact that significantly more patients who had a higher body mass index (BMI) and were of ASA class 3 and above in the general anesthesia group, hypoxic events of less than 84% were much more common in patients having AAS then those who had general anesthesia (15% in AAS vs 6.7% in general anesthesia). On the other hand, hypotension (34% in general anesthesia vs 4% in AAS,) and arrhythmias (8% in general anesthesia vs 3% in AAS) were much more frequent in general anesthesia group than AAS. Upto 4% of patients had to be converted to general anesthesia due to cardiopulmonary compromise. However, the conclusion drawn was that AAS is as safe and effective as general anesthesia. Major caveats bring into question the conclusion. The studies were observational and non-randomized which introduces selection bias.

A recent randomized controlled trail that looked at general anesthesia versu AAS during ERCP concluded general anesthesia had a better safety profile than AAS (17). However, this study included only patient who were high risk for sedation related adverse events with ASA class >3 and the anesthesia was provided by nurse anesthetist. Hence, these results cannot be generalized. There are no randomized trials comparing AAS with general anesthesia in patients with ASA ≤3, which includes the vast majority of patients having ERCP

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Study Type : Observational
Estimated Enrollment : 204 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Actual Study Start Date : September 8, 2019
Estimated Primary Completion Date : May 20, 2022
Estimated Study Completion Date : May 20, 2022

General Anesthesia

All the patients will be intubated and ventilated using cisatracurium (0.15 mg/kg) as a muscle relaxant and propofol (1.5-2mg/kg) for induction. The inhalational anesthetic, sevoflurane, will be used to maintain the depth of anesthesia using 50% mix of nitrous oxide and oxygen.

Fentanyl will be used in both groups at a rate of 1-2 microgram /kg to achieve an adequate level of analgesia in both groups.

Anesthetist Administered sedation for ERCP
To ensure a steady level of AAS each patient in this group will be sedated using propofol. An induction bolus of propofol (0.5 - 1 mg/kg) will be administered followed by continuous infusion with variable doses depending on the patients' age, weight, and clinical condition. In addition, fentanyl 1.5 μg/kg will be used at the anesthetist discretion.

Primary Outcome Measures :
  1. The safety of anesthetist administered sedation (AAS) with general anesthesia for ERCP. [ Time Frame: 2 years ]
    Significant cardiopulmonary complications will be defined as 1) Hypotension - when systolic BP drops below 25% of the baseline measurement requiring vasopressor drugs; 2) Cardiac Arrythmia - Bradycardia when heart rate drops below 50 beats/min or rises above 120 beats/min requiring treatment; 3) Hypoxia - when oxygen saturation falls below 90%; 4) Hypercapnia - when expiratory carbon dioxide increase by more than 25% from the baseline; 5) Apnea when respiratory activity ceases for ≥10 seconds via capnography; 6) Any interruption or termination of ERCP procedure related to sedation

Secondary Outcome Measures :
  1. -The patient and endoscopist satisfaction with both types of sedation -The recovery time of AAS and general anesthesia [ Time Frame: 2 years ]
    -Sedation induction time - the time from start of sedation till intubation of scope; - Procedure time - time from scope intubation till scope withdrawal; - Recovery time - time from scope withdrawal till recovery to healthy state scoring 10 on Aldrete system. - Success of ERCP - technical success of achieving deep cannulation of the ducts of interest in patients with native papillae without surgically altered anatomy; - Complications of ERCP - bleeding, perforation, pancreatitis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
all consecutive patients referred for ERCP who meet the below criteria will be approached to participate in the study

Inclusion Criteria:

  • Age >18 years
  • Referred for ERCP
  • Assessed by anesthetist
  • ASA 1-3

Exclusion Criteria:

  • Emergency situation (upper GI bleed, on mechanical ventilation)
  • ASA class ≥4
  • Distorted anatomy - like partial or total gastrectomy
  • Pregnancy
  • Unable to give or obtain consent and/ or disturbed level of consciousness
  • Suspected difficult intubation using Ganzouri score > than 5 (18).
  • Allergy to any study medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099693

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Contact: Adnan Zanbagi, MD +96625549999 ext 10751 Alzanbagi.A2@kamc.med.sa
Contact: Mohammad K Shariff, MD Alzanbagi.A2@kamc.med.sa ext 10751 Shariff.M@kamc.med.sa

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Saudi Arabia
King Abdullah Medical City, Holy Capital Recruiting
Mecca, Makkah Western, Saudi Arabia, 21955
Contact: Rania M Felemban, Msc    0096625549999 ext 18013    felembanr@kamc.med.sa   
Contact: Wedian O Almowlad, Msc    0096625549999 ext 18004    Almwlld.W@kamc.med.sa   
Sponsors and Collaborators
King Abdullah Medical City
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King Abdullah Medical City
ClinicalTrials.gov Identifier: NCT04099693    
Other Study ID Numbers: 18-492
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No