Sedation for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography

April 22, 2021 updated by: Gaurav Sindwani, Institute of Liver and Biliary Sciences, India

Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography: A Comparison Between Conventional Versus Bispectral Index Guided Approach and Effect of Diclofenac Sodium Along With Topical Pharyngeal Anaesthesia

This study was performed to evaluate the role of BIS monitored sedation in reducing the dose of propofol and to know the effectiveness of pre-procedure administration of intravenous diclofenac sodium along with topical pharyngeal anesthesia in reducing the dose of propofol in patients undergoing endoscopic retrograde cholangiopancreatography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It was a single-center open-labeled Prospective Randomized study. After approval of the study by the institutional ethical committee & obtaining written informed consent, 90 patients scheduled for ERCP procedure were randomized by using the block randomization method into the following three groups, Group A (n=30)-The intravenous infusion of propofol was administered for the ERCP procedure based on clinical judgment and the patient's requirement.

Group B (n=30) - The intravenous infusion of propofol was administered for ERCP procedure titrated to BIS value 60-80.

Group C (n=30) - Patients received 75 mg of inj. Diclofenac sodium (diluted in 100 ml of 0.9 % normal saline) intravenously 30 mins before the start of procedure & topical pharyngeal anesthesia with 4 squirts of 10% lidocaine spray ( one squirt each to posterior pharyngeal wall, base of tongue, and bilateral palatoglossal and palatopharyngeal folds ) 5 mins before the start of ERCP procedure. Intravenous infusion of propofol was administered for ERCP procedure titrated to BIS value 60-80.

In all three groups, after completing the standard pre-anesthesia checklist, patients were positioned in the semi prone-position and standard ASA monitors were attached (electrocardiogram, pulse oximetry, and non-invasive blood pressure, EtCO2). Also, the BIS monitor was attached in group B & group C. Baseline values were noted before the start of sedation. Supplemental oxygen was provided by nasal prongs @ 2/min. Patients in all groups were sedated with an initial bolus dose of fentanyl 1 mcg/kg & propofol 1-1.5 mg/kg intravenously. Sedation was maintained with propofol infusion at the rate of 80-100 mcg/kg/min. In group A, propofol sedation was further titrated based on clinical judgment and patient's requirement. Whereas in group B & group C, propofol sedation was further titrated to maintain a BIS value between 60-80. If the patient moves despite BIS 60-80, an additional bolus of 30 mg i.v. propofol was administered. In addition to these, i.v. fentanyl 25mcg was administered as a rescue analgesic.All pre-procedure drugs were administered in the preoperative room with standard ASA monitoring.

Hemodynamic parameters were monitored at 5-min intervals. The incidence and number of episodes of patient's movements, cough/gag reflex, and hiccups were noted. The incidence of desaturation (fall in oxygen saturation < 94 % with oxygen supplementation), hypotension (17) (defined as systolic blood pressure < 90 mm of Hg ), and bradycardia (defined as HR < 50 beats per minute) was also be noted. Standard anesthesia protocol was followed for the management of desaturation and hemodynamic instability. Desaturation was managed by chin lift & jaw thrust maneuver. The nasal airway was inserted if deemed necessary by the concerned anesthetist. Further, if desaturation persists & lack of respiratory effort is seen for more than 20 seconds, sedation was discontinued, and mask ventilation is initiated in the lateral position. Insertion of supraglottic airway devise or tracheal intubation (after turning the patient supine) performed as per anesthetist discretion and the patient will be excluded from the study. Hypotension managed with 6-12 mg of intravenous ephedrine or a fluid bolus of 500 cc of plasmalyte. Bradycardia is managed by 0.6 mg of intravenous atropine.

At the end of the procedure, propofol infusion was stopped and the total dose of propofol administered in mg/kg/hr was calculated. Thereafter, time to achieve eye-opening to verbal commands was calculated.

Post-procedure, patients were nursed in the left lateral position, and vitals (HR, NIBP, SpO2) was noted every 5 mins. Also, readiness to discharge is assessed by the noting post-anesthesia discharge score (PADS) every 15 mins. For patients having breakthrough pain, 1 gram iv paracetamol was administered in all the groups. The endpoint of complete recovery was a PADS score of 10. Also at the end of the procedure, the endoscopist was asked to grade ease of procedure based on 1=poor, 2=fair, 3=acceptable, 4=good, 5=excellent scale.

At the time of discharge, the patient's satisfaction for the ERCP procedure was grade on 1=unacceptable, 2=extremely uncomfortable, 3=slightly uncomfortable, 4=no discomfort scale.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110060
        • Gaurav Sindwani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18-65 yrs
  2. ASA I & II

Exclusion Criteria:

  1. Age < 18 yrs & > 65 yrs
  2. ASA III & IV patients
  3. Chronic Liver Disease
  4. Pregnant patients
  5. Patients with a history of (H/O) Drug abuse
  6. Patients refusing consent
  7. H/o Acute kidney injury
  8. H/o allergy to propofol / lidocaine/ NSAIDS
  9. Post liver transplant patients
  10. Patients with h/o egg allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group A
The intravenous infusion of propofol was administered for ERCP procedure based on clinical judgment and the patient's requirement.
Active Comparator: Group B
The intravenous infusion of propofol was administered for ERCP procedure titrated to BIS value 60-80.
Drug: Propofol
Injection propofol was given to keep the BIS value 60-80 during the ERCP procedure
Other Names:
  • Neorof
Active Comparator: Group C
Patients received 75 mg of inj. Diclofenac sodium (diluted in 100 ml of 0.9 % normal saline) intravenously 30 mins before the start of procedure & topical pharyngeal anesthesia with 4 squirts of 10% lidocaine spray ( one squirt each to posterior pharyngeal wall, base of tongue, and bilateral palatoglossal and palatopharyngeal folds ) 5 mins before the start of ERCP procedure. Intravenous infusion of propofol was administered for ERCP procedure titrated to BIS value 60-80.
Drug: Diclofenac Sodium and Lignocaine 10 % spray
Injection Diclofenac sodium was given in the preoperative area 30 minutes before the procedure and four squirts of 10% lignocaine were given 5 minutes prior to the start of the procedure
Other Names:
  • Dynapar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total dose of propofol required in mg/kg/hr during ERCP procedure among different groups.
Time Frame: 2 hours
Total dose of propofol required to complete the ERCP procedure was noted
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean recovery time between different groups.
Time Frame: 24 hours
Total time taken by the patient to reach a post-anesthesia discharge score of 10 was taken as the mean recovery time
24 hours
Time taken to achieve eye opening to verbal stimulus among different groups
Time Frame: 24 hours
Total time taken by the patient to open eyes in response to the verbal commands after the propofol was stopped
24 hours
Incidence of hypotension, bradycardia, limb movements and gag reflex during the ERCP procedure
Time Frame: 24 hours
Incidence of hypotension, bradycardia, limb movement and gag reflex was noted during the ERCP procedure
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: gaurav sindwani, md, ILBS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

September 26, 2019

Study Completion (Actual)

November 14, 2019

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBSIndia3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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