Clinical trial NCT04860167: Sedation for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Colic
Keywords: Diclofenac
Propofol
Topical anaesthesia
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total dose of propofol required in mg/kg/hr during ERCP procedure among different groups.
timeFrame: 2 hours
Secondary outcomes:
measure: Mean recovery time between different groups.
timeFrame: 24 hours
measure: Time taken to achieve eye opening to verbal stimulus among different groups
timeFrame: 24 hours
measure: Incidence of hypotension, bradycardia, limb movements and gag reflex during the ERCP procedure
timeFrame: 24 hours
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Gaurav Sindwani
state: Delhi
Study officials:
affiliation: ilbs
name: gaurav sindwani, md
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Quesada N, Judez D, Martinez Ubieto J, Pascual A, Chacon E, De Pablo F, Minchole E, Bello S. Bispectral Index Monitoring Reduces the Dosage of Propofol and Adverse Events in Sedation for Endobronchial Ultrasound. Respiration. 2016;92(3):166-75. doi: 10.1159/000448433. Epub 2016 Sep 7.
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citation: Paspatis GA, Chainaki I, Manolaraki MM, Vardas E, Theodoropoulou A, Tribonias G, Konstantinidis K, Karmiris K, Chlouverakis G. Efficacy of bispectral index monitoring as an adjunct to propofol deep sedation for ERCP: a randomized controlled trial. Endoscopy. 2009 Dec;41(12):1046-51. doi: 10.1055/s-0029-1215342. Epub 2009 Dec 4.