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Anesthesia; Adverse EffectNCT04087668

Different Anesthetic Technique For ERCP

A study testing Monitored Anesthesia Care, General Anesthesia and Induction Without Neuromuscular Blockade in people with Anesthesia; Adverse Effect, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Providing the appropriate anesthetic technique for endoscopic retrograde cholangiopancreatography (ERCP) in remote locations can be challenging. The aim of this study was therefore to prospectively assess and compare the feasibility of monitored anesthesia care (MAC) with propofol based deep sedation, standard general… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anesthesia; Adverse Effect
What is being tested?
Monitored Anesthesia Care, General Anesthesia and Induction Without Neuromuscular Blockade
Could I receive a placebo?
No, everyone receives an active treatment
How many people
405 participants
Where
1 siteChina
Study dates
1 Sep 2019to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-70 years old
  • Grade Ⅰ and Ⅲ according to physical status classification system of the American Society of Anesthesiologists (ASA)
  • Coagulation function tests in normal range

Who cannot join

  • Potentially difficult airways
  • Administration of sedative or narcotic drugs in the previous 24 hours
  • Severe renal or hepatic impairment
  • Severe cardiopulmonary comorbidities (defined as American Society of Anesthesiologists physical status IV or greater)
  • Contraindications to a nasotracheal intubation
  • Coagulopathy
Show all 9Show fewer
  • History of frequent episodes of epistaxis
  • Emergent ERCP
  • At risk for reflux and aspiration

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography

Providing the appropriate anesthetic technique for endoscopic retrograde cholangiopancreatography (ERCP) in remote locations can be challenging. The aim of this study was therefore to prospectively assess and compare the feasibility of monitored anesthesia care (MAC) with propofol based deep sedation, standard general anesthesia and general anesthesia without neuromuscular blockade in patients undergoing ERCP.

Read the detailed description

ERCP is identified as one of the most invasive endoscopic procedures, during which patients may experience anxiety, discomfort and suffer different degree of pain. So, anesthesia and analgesia are essential for this invasive procedure, especially therapeutic ERCPs. Thus, we compared the efficacy of using monitored anesthesia care (MAC) with deep sedation versus general anesthesia (GA) to perform this procedure and the incidence of complications associated with these methods of anesthesia.

Previous studies have concluded that intubation is possible without the use of neuromuscular blockade. We assume that the use of propofol and adjuvants short-acting opioids may provide adequate conditions for tracheal intubation. It was also hypothesized that it may also be useful in facilitating ERCP under general anesthesia without neuromuscular blockade.

Being tested
Monitored Anesthesia Care, General Anesthesia, Induction Without Neuromuscular Blockade
Keywords
ERCP, General anesthesia, Endoscopy, MAC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitored Anesthesia CareProcedure or surgery

    MAC was induced and maintained via the continuous infusion of propofol AND remifentanil using a target-controlled infusion (TCI) pump. The appropriate level of sedation was 65 to 80 points on BIS. The adjunctive sedatives (eg, fentanyl, midazolam) was at the discretion of the anesthesia team.

  • General AnesthesiaProcedure or surgery

    Induction was done with propofol (2 mg/kg) , cis-atracurium (0.15 mg/kg) , and fentanyl (5μg/kg). After orotracheal intubation, general anesthesia was maintained with sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min) and repetitive doses of 0.1mg atracurium per kilogram were administered. After the procedure was completed, neostigmine mixed with atropine was used as a reversal agent for the neuromuscular blockade, and the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .

  • Induction Without Neuromuscular BlockadeProcedure or surgery

    Anaesthesia was induced with propofol (2 mg/kg), remifentanil(3 ug/kg) and 2% lidocaine (1 mg/kg). Nasotracheal intubation was performed 60 s after the administration. After intubation, general anesthesia was sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min). After the procedure was completed, the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .

Study groups in NCT04087668
Study groupRoleWhat they receive
Monitored Anesthesia CareOtherPatients in this arm will undergo an ERCP using monitored anesthesia care (MAC) with propofol based deep sedation.
Receives: Procedure: Monitored Anesthesia Care
General AnesthesiaOtherPatients in this arm will receive standard general anesthesia with neuromuscular blockade.
Receives: Procedure: General Anesthesia
General Anesthesia Without Neuromuscular BlockadeOtherPatients in this arm will receive nasotracheal intubation without neuromuscular blockade.
Receives: Procedure: Induction Without Neuromuscular Blockade

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The overall complication rate

    The primary outcome was the overall pulmonary and cardiac complication rate.

    Measured: within 72 hours of ERCP

Secondary outcomes (9)

  1. Conversion to GA

    Conversion to general anesthesia

    Measured: During the procedure

  2. Temporary interruption rate of ERCP

    Measured: During the procedure

  3. Premature termination rate of ERCP

    Measured: During the procedure

  4. Procedural failure rate of ERCP

    Measured: During the procedure

  5. Procedure time

    Measured: During the procedure

  6. Anesthesia time

    Measured: During the procedure

  7. Room time

    Patient room-in to room-out time in the ERCP suite ("room time").

    Measured: During the procedure

  8. Immediate Adverse Events

    Measured: within 24 hours of ERCP

  9. Delayed Adverse Events

    Measured: within 72 hours of ERCP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study start1 Sep 2019
  3. Primary completion30 Dec 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04087668
Sponsor's protocol ID
2019-SR-205
Status last verified
May 2023
First submitted
9 Sep 2019
Last updated
24 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smith A, Silvestro L, Rodriguez RE, Austin PN. Evidence-Based Selection of Sedation Agents for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Gastroenterol Nurs. 2016 Jan-Feb;39(1):32-41. doi: 10.1097/SGA.0000000000000195.

    PubMed 26825562

  • Yang JF, Farooq P, Zwilling K, Patel D, Siddiqui AA. Efficacy and Safety of Propofol-Mediated Sedation for Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). Dig Dis Sci. 2016 Jun;61(6):1686-91. doi: 10.1007/s10620-016-4043-3. Epub 2016 Jan 29.

    PubMed 26825844

  • Barnett SR, Berzin T, Sanaka S, Pleskow D, Sawhney M, Chuttani R. Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci. 2013 Nov;58(11):3287-92. doi: 10.1007/s10620-013-2783-x. Epub 2013 Jul 23.

    PubMed 23877477

  • Coghlan SF, McDonald PF, Csepregi G. Use of alfentanil with propofol for nasotracheal intubation without neuromuscular block. Br J Anaesth. 1993 Jan;70(1):89-91. doi: 10.1093/bja/70.1.89.

    PubMed 8431342

  • Grant S, Noble S, Woods A, Murdoch J, Davidson A. Assessment of intubating conditions in adults after induction with propofol and varying doses of remifentanil. Br J Anaesth. 1998 Oct;81(4):540-3. doi: 10.1093/bja/81.4.540.

    PubMed 9924229

  • Erhan E, Ugur G, Gunusen I, Alper I, Ozyar B. Propofol - not thiopental or etomidate - with remifentanil provides adequate intubating conditions in the absence of neuromuscular blockade. Can J Anaesth. 2003 Feb;50(2):108-15. doi: 10.1007/BF03017840.

    PubMed 12560298

  • Klemola UM, Mennander S, Saarnivaara L. Tracheal intubation without the use of muscle relaxants: remifentanil or alfentanil in combination with propofol. Acta Anaesthesiol Scand. 2000 Apr;44(4):465-9. doi: 10.1034/j.1399-6576.2000.440419.x.

    PubMed 10757583

Questions about this trial

What is this clinical trial studying?

A study testing Monitored Anesthesia Care, General Anesthesia and Induction Without Neuromuscular Blockade in people with Anesthesia; Adverse Effect, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The overall complication rate (time frame: within 72 hours of ERCP). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04087668, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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